1. ALPHARETTA, Ga., April 05, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer, will present at two upcoming virtual conferences in April 2021:

    Needham Virtual Healthcare Conference
    Monday, April 12, 2021 at 12:45 p.m. ET

    • The live and archived Needham Virtual Healthcare Conference presentation webcast may be accessed on the Clearside website under the Investors section: Events and Presentations.

    Wet AMD & DME Drug Development Summit
    Wednesday, April 14, 2021
    Event…

    ALPHARETTA, Ga., April 05, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer, will present at two upcoming virtual conferences in April 2021:

    Needham Virtual Healthcare Conference

    Monday, April 12, 2021 at 12:45 p.m. ET

    • The live and archived Needham Virtual Healthcare Conference presentation webcast may be accessed on the Clearside website under the Investors section: Events and Presentations.

    Wet AMD & DME Drug Development Summit

    Wednesday, April 14, 2021

    Event details are available on the conference website.

    • 10:45 a.m. ET - Panel Discussion: Ending the Burden of Monthly Treatments – Mechanisms to Increasing the Durability & Accessibility of Wet AMD & DME Therapeutics
    • 1:40 p.m. ET - Suprachoroidal Drug Delivery & CLS-AX: A Potential Solution for Treatment Burden
    • 2:55 p.m. ET - Chair Led Q&A: Making Strides Forward in Drug Delivery & Dosing

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:

    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

     



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  2. - OASIS Wet AMD Phase 1/2a Trial Initiated and Cohort 1 Dosing Completed -

    - Initial Safety Data from OASIS Trial Expected Mid-2021 -

    - Four Ongoing Internal & Partner Clinical Trials Using Clearside's SCS Microinjector®-

    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., March 10, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update.

    "Over the past year, our team has executed on our key initiatives…

    - OASIS Wet AMD Phase 1/2a Trial Initiated and Cohort 1 Dosing Completed -

    - Initial Safety Data from OASIS Trial Expected Mid-2021 -

    - Four Ongoing Internal & Partner Clinical Trials Using Clearside's SCS Microinjector® -

    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., March 10, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update.

    "Over the past year, our team has executed on our key initiatives with purpose and focus," said George Lasezkay, Pharm.D., J.D., Clearside's President and Chief Executive Officer. "As the pioneers in treating back of the eye diseases through the suprachoroidal space, we expanded the use of our first in class, proprietary SCS Microinjector® into four clinical programs in the U.S. based on our internal product pipeline and our collaborators' efforts."

    "We advanced our high-potential CLS-AX program with suprachoroidally-administered axitinib into the clinic and have fully enrolled and completed dosing in Cohort 1 of OASIS, our Phase 1/2a trial in patients with neovascular age-related macular degeneration (wet AMD). We expect to report initial safety data from Cohort 1 in mid-2021. In addition, we remain on track to resubmit our New Drug Application for XIPERE™ in the second quarter of 2021, which is in line with our prior guidance. With our recently completed financings, we are well-funded to reach multiple potential value-creating events over the next 12 months," concluded Dr. Lasezkay.

    Key Highlights and Anticipated Milestones

    • Initiation of OASIS, Clearside's U.S. based, open-label, dose-escalation Phase 1/2a trial in wet AMD patients, to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection via Clearside's SCS Microinjector®.
    • Completion of patient dosing in Cohort 1 of the OASIS trial with initial safety data expected mid-2021.
    • Completion of registered direct offering of 4.2 million shares in January 2021, resulting in total gross proceeds of approximately $12.0 million.
    • Clearside's adeno-associated virus (AAV)-based gene therapy partner, REGENXBIO, expects to: report interim efficacy data in the third quarter of 2021 from Cohort 1 and complete enrollment in Cohort 2 in the second quarter of 2021 in AAVIATE™, a Phase 2 trial for treatment of wet AMD; and report initial data from ALTITUDE, a Phase 2 trial for treatment of diabetic retinopathy, in 2021.
    • Multiple presentations featuring Clearside's suprachoroidal injection platform in a range of indications, including wet AMD, uveitis, diabetic macular edema and ocular gene therapy, were highlighted at global conferences, including the American Academy of Ophthalmology Annual Meeting, the 44th Annual Meeting of The Macula Society and the Angiogenesis, Exudation, and Degeneration 2021 Meeting.
    • Data was published in the British Journal of Ophthalmology in February 2021 titled "Suprachoroidal CLS-TA for Non-infectious Uveitis: an Open-label, Safety Trial (AZALEA)".
    • Data was published in Expert Opinion on Drug Delivery in January 2021 titled "Biomechanics of Suprachoroidal Drug Delivery: From Benchtop to Clinical Investigation in Ocular Therapies".
    • Data was published in Translational Vision Science & Technology, a journal of the Association for Research in Vision and Ophthalmology, in December 2020 titled "Suprachoroidally Delivered DNA Nanoparticles Transfect Retina and Retinal Pigment Epithelium/Choroid in Rabbits".

    Fourth Quarter 2020 Financial Results

    Clearside's license and other revenue for the fourth quarter of 2020 was $11,000, compared to $1.9 million for the fourth quarter of 2019. The $1.9 million decrease was primarily attributable to lower revenue from partner licensing agreements in the fourth quarter of 2020.

    Research and development expenses for the fourth quarter of 2020 were $4.5 million, compared to $1.3 million for the fourth quarter of 2019. The $3.2 million increase was primarily attributable to increased expenses related to preparation for initiation of the CLS-AX Phase 1/2a clinical trial and costs related to drug manufacturing activities for XIPERE.

    General and administrative expenses for the fourth quarter of 2020 were $2.6 million, compared to $3.7 million for the fourth quarter of 2019. The $1.0 million decrease was primarily attributable to reduced marketing-related expenses resulting from the out-licensing of XIPERE commercialization.

    Net loss for the fourth quarter of 2020 was $7.1 million, or $0.14 per share of common stock, compared to a net loss of $3.1 million, or $0.07 per share of common stock, for the fourth quarter of 2019. The increase in net loss was primarily attributable to higher research and development expenses in the fourth quarter of 2020.  

    Full Year 2020 Financial Results

    Clearside's license and other revenue for the year ended December 31, 2020 was $7.9 million, compared to $2.2 million for the year ended December 31, 2019. The $5.7 million increase was primarily attributable to higher revenue from partner licensing agreements in 2020.

    Research and development expenses for the year ended December 31, 2020 were $15.1 million, compared to $15.7 million for the year ended December 31, 2019.

    General and administrative expenses for the year ended December 31, 2020 were $10.8 million, compared to $16.8 million for the year ended December 31, 2019. The $6.1 million decrease was primarily attributable to reduced marketing-related expenses resulting from the out-licensing of XIPERE commercialization.

    Net loss for the year ended December 31, 2020 was $18.2 million, or $0.39 per share of common stock, compared to a net loss of $30.8 million, or $0.81 per share of common stock, for the year ended December 31, 2019. The decrease in net loss was primarily attributable to higher revenue from partner licensing agreements and lower general and administrative expenses in 2020.  

    As of December 31, 2020, Clearside's cash and cash equivalents totaled $17.3 million. In January 2021, aggregate net proceeds of $14.4 million were raised from a registered direct offering of 4.2 million shares and issuances of 1.2 million shares through an at-the-market agreement. The Company believes it will have sufficient resources to fund its planned operations into the first quarter of 2022, not including receipt of potential partner milestone payments.

    Conference Call & Webcast Details

    Clearside's management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 5286349. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development, including the timing of safety data from the OASIS clinical trial, and the potential benefits, of CLS-AX and therapies using Clearside's SCS Microinjector®, the timeline for resubmitting the NDA for XIPERE and Clearside's ability to fund its operations into the first quarter of 2022. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    -Financial Tables Follow-

    CLEARSIDE BIOMEDICAL, INC.

    Selected Financial Data

    (in thousands, except share and per share data)

    (unaudited)

    Statements of Operations DataThree Months Ended 

    December 31,
      Twelve Months Ended 

    December 31,
     
     2020  2019  2020  2019 
    License and other revenue$11  $1,942  $7,894  $2,173 
    Operating expenses:               
    Research and development 4,472   1,305   15,073   15,658 
    General and administrative 2,649   3,650   10,756   16,819 
    Total operating expenses 7,121   4,955   25,829   32,477 
    Loss from operations (7,110)  (3,013)  (17,935)  (30,304)
    Other expense (2)  (83)  (275)  (466)
    Net loss$(7,112) $(3,096) $(18,210) $(30,770)
    Net loss per share of common stock — basic and diluted$(0.14) $(0.07) $(0.39) $(0.81)
    Weighted average shares outstanding — basic and diluted 49,048,402   42,394,959   46,506,540   38,170,830 



    Balance Sheet DataDecember 31,  December 31, 
     2020  2019 
            
    Cash and cash equivalents$17,287  $22,595 
    Total assets 19,322   26,776 
    Deferred revenue 5,000   5,000 
    Long-term debt (including current portion) 991   5,152 
    Total liabilities 10,559   15,619 
    Total stockholders' equity 8,763   11,157 

    Source: Clearside Biomedical, Inc.



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  3. - Initial Safety Data from First Cohort Expected Mid-2021 -

    ALPHARETTA, Ga., March 02, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today completion of dosing in the first cohort of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD).

    OASIS is a U.S.-based, multi-center, open-label, dose-escalation trial in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection. The first cohort…

    - Initial Safety Data from First Cohort Expected Mid-2021 -

    ALPHARETTA, Ga., March 02, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today completion of dosing in the first cohort of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD).

    OASIS is a U.S.-based, multi-center, open-label, dose-escalation trial in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection. The first cohort of patients have received aflibercept at their first visit and a single dose of CLS-AX at their second visit one month later. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for three months following the administration of CLS-AX.

    "We are pleased to have made rapid progress enrolling patients in our OASIS trial evaluating the use of axitinib, a highly-potent small molecule tyrosine kinase inhibitor (TKI), administered by suprachoroidal injection," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "This progress was made possible through the combined efforts and commitment by patients, investigators, advisors and our internal team. We believe that by combining the high potency and pan-VEGF attributes of axitinib with our proprietary CLS-AX formulation and delivery via our SCS Microinjector®, we may extend the duration of therapeutic action and reduce or relieve the profound treatment burden for wet AMD patients. We expect to report initial safety data from this first cohort of patients in mid-2021 and continue on to a higher dose in the next cohort in the second half of the year."

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effects with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. CLS-AX is currently being investigated in an ongoing U.S.-based, multi-center, open-label, dose-escalation, Phase 1/2a, safety and tolerability study, entitled OASIS, in wet AMD patients, and additional information can be found on https://clinicaltrials.gov (NCT04626128).

    About the OASIS Phase 1/2a Clinical Trial

    OASIS is an open-label, dose-escalation Phase 1/2a trial in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection via Clearside's SCS Microinjector®. Eligible patients are those who demonstrate stable visual acuity following two or more previous injections with an intravitreal anti-VEGF agent. Enrolled patients initially receive aflibercept at the first visit followed by a single dose of CLS-AX at the second visit one month later. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for the three months following the administration of CLS-AX, and secondary endpoints will evaluate the pharmacokinetics, visual function, ocular anatomy, and the need for additional treatment with intravitreal aflibercept during the three-month period.

    The study design is planned with 3 cohorts of approximately 5 patients each (n=15). Cohort 1 participants received the lowest dose, 0.03 mg of axitinib delivered via suprachoroidal injection. Dose escalation will then proceed following review of the safety data by the Safety Monitoring Committee and their recommendation to advance to the next higher dose cohort. Additional information on the Phase 1/2a trial can be found on https://clinicaltrials.gov (NCT04626128).

    About Clearside's SCS Microinjector®

    Clearside's patented, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is composed of a syringe and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, within a custom-designed hub that optimizes insertion and suprachoroidal administration of drugs.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development, including the timing of safety data from the OASIS clinical trial, and the potential benefits, of CLS-AX and therapies using Clearside's SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



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  4. ALPHARETTA, Ga., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its fourth quarter and full year 2020 financial results will be reported on Wednesday, March 10, 2021 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213…

    ALPHARETTA, Ga., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its fourth quarter and full year 2020 financial results will be reported on Wednesday, March 10, 2021 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 5286349. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



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  5. ALPHARETTA, Ga., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the Company will participate in two upcoming investor conferences in March 2021:

    Cowen 41st Annual Health Care Conference
    Blazing New Paths in Clinical Development and Structure Panel
    Tuesday, March 2, 2021 at 2:10 pm ET

    33rd Annual ROTH Conference
    Ophthalmology Panel
    Tuesday, March 16, 2021 at 9:00 am ET

    The panels will be available for attendees on the conference websites. Management will be participating in live, virtual one-on-one meetings with investors who are registered…

    ALPHARETTA, Ga., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the Company will participate in two upcoming investor conferences in March 2021:

    Cowen 41st Annual Health Care Conference

    Blazing New Paths in Clinical Development and Structure Panel

    Tuesday, March 2, 2021 at 2:10 pm ET

    33rd Annual ROTH Conference

    Ophthalmology Panel

    Tuesday, March 16, 2021 at 9:00 am ET

    The panels will be available for attendees on the conference websites. Management will be participating in live, virtual one-on-one meetings with investors who are registered to attend the conferences.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



    Primary Logo

    View Full Article Hide Full Article
  6. ALPHARETTA, Ga., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that David M. Brown, M.D. delivered a presentation entitled, "Axitinib: A Novel TKI Delivered by Suprachoroidal Injection for AMD" at the virtual Angiogenesis, Exudation, and Degeneration 2021 program hosted by the University of Miami Health System Bascom Palmer Eye Institute on February 12 & 13, 2021.

    Dr. Brown's presentation highlighted several of the key attributes of axitinib and Clearside's suprachoroidal delivery of the agent, including the ease of administration as…

    ALPHARETTA, Ga., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that David M. Brown, M.D. delivered a presentation entitled, "Axitinib: A Novel TKI Delivered by Suprachoroidal Injection for AMD" at the virtual Angiogenesis, Exudation, and Degeneration 2021 program hosted by the University of Miami Health System Bascom Palmer Eye Institute on February 12 & 13, 2021.

    Dr. Brown's presentation highlighted several of the key attributes of axitinib and Clearside's suprachoroidal delivery of the agent, including the ease of administration as demonstrated in a video of a clinical trial patient undergoing the office-based suprachoroidal delivery procedure. In preclinical studies, axitinib showed intrinsic high potency, pan-VEGF inhibition through receptor blockade versus focused VEGF-A inhibition seen in currently marketed anti-VEGF treatments. Axitinib is a highly potent tyrosine kinase inhibitor (TKI) that has been observed preclinically to be greater than ten times more potent than other TKIs, and inhibits and regresses angiogenesis.

    Suprachoroidal delivery of Clearside's proprietary, injectable suspension of axitinib, known as CLS-AX, has produced up to eleven times higher drug levels in affected tissues than intravitreal administration of axitinib in preclinical models. This compartmentalized delivery to affected posterior tissues may minimize treatment related adverse events, such as vitreous floaters and corneal and anterior segment exposure. With the prolonged duration observed in pharmacokinetic studies, this targeted treatment approach also has the potential to reduce treatment burden for patients.

    "We appreciate Dr. Brown's thorough presentation which highlighted the potential of axitinib and CLS-AX to improve the treatment landscape for the millions of patients suffering from wet AMD," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "By combining the high potency and pan-VEGF attributes of axitinib with our proprietary CLS-AX formulation and delivery via our SCS Microinjector®, we believe we can achieve clinical adoption of this technique by the retina community and improve the overall patient experience with a longer lasting treatment that may reduce or eliminate the challenging side effects seen with other agents. Our Phase 1/2a OASIS clinical trial in wet AMD is an ongoing US-based, multi center, open-label, dose-escalation, safety and tolerability study. We expect to report initial safety data from the first OASIS cohort mid-year 2021."

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effects with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. CLS-AX is currently being investigated in an ongoing US-based, multi-center, open-label, dose-escalation, Phase 1/2a, safety and tolerability study, entitled OASIS, in wet AMD patients, and additional information can be found on https://clinicaltrials.gov (NCT04626128).

    About Clearside's SCS Microinjector®

    Clearside's patented, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is composed of a syringe and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, within a custom-designed hub that optimizes insertion and suprachoroidal administration of drugs.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development, including the timing of safety data from the OASIS clinical trial, and the potential benefits, of CLS-AX and therapies using Clearside's SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



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  7. - Proprietary suprachoroidal injection platform demonstrates broad applicability across multiple retinal disorders -

    - CLS-AX will also be featured at the upcoming virtual Angiogenesis, Exudation, and Degeneration 2021 conference on February 13, 2021 -

    ALPHARETTA, Ga., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that numerous clinical presentations were delivered at the 44th Virtual Annual Macula Society Meeting which took place February 6-7, 2021. Clearside also announced that David M. Brown, M.D. will deliver a presentation entitled…

    - Proprietary suprachoroidal injection platform demonstrates broad applicability across multiple retinal disorders -

    - CLS-AX will also be featured at the upcoming virtual Angiogenesis, Exudation, and Degeneration 2021 conference on February 13, 2021 -

    ALPHARETTA, Ga., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that numerous clinical presentations were delivered at the 44th Virtual Annual Macula Society Meeting which took place February 6-7, 2021. Clearside also announced that David M. Brown, M.D. will deliver a presentation entitled, "Axitinib: A Novel TKI Delivered by Suprachoroidal Injection for AMD" at the virtual Angiogenesis, Exudation, and Degeneration 2021 event hosted by the University of Miami Health System Bascom Palmer Eye Institute on February 13, 2021.

    "With well over one thousand injections performed to date, the mounting evidence points to the potential reliability and consistency of our suprachoroidal injection delivery approach," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "Our SCS Microinjector® has now been used to deliver small molecules, gene therapy and viral nanoparticle conjugates in eye diseases including macular edema associated with uveitis, neovascular age-related macular degeneration (wet AMD), diabetic retinopathy, and choroidal melanoma. With its broad applicability and in-office delivery method, our suprachoroidal injection platform could facilitate novel targeted treatment options for patients suffering from retinal diseases."

    CLS-AX (axitinib injectable suspension) and other therapies

    Title: Suprachoroidal Administration of Small Molecule and Nanoparticle Suspensions: Pre-Clinical Results Correlate to Clinical Trial Outcomes

    Lead Author: Mathew MacCumber, MD, PhD

    Conclusions: Suprachoroidal delivery of small molecule suspensions, including corticosteroids, tyrosine kinase inhibitors (TKIs), complement inhibitors, and nanoparticles, has undergone investigation based on the potential for targeted delivery to affected tissues for efficacy, compartmentalization away from unaffected tissues for safety, and durability to address treatment burden. Several small molecule suspensions, including axitinib, a potent TKI that has shown inhibition of angiogenesis in multiple ocular models, exhibited prolonged durability when injected suprachoroidally in preclinical pharmacokinetic studies. Favorable results from preclinical studies of a triamcinolone acetonide suspension translated to favorable clinical trial results for macular edema associated with non-infectious uveitis. There is potential for similar read-through of preclinical studies in the four current clinical trials enrolling patients utilizing suprachoroidal injection with the SCS Microinjector®: CLS-AX for wet AMD; viral vector RX-314 for wet AMD and diabetic retinopathy; and viral-like particle AU-011 for choroidal melanoma.

    Suprachoroidal Space Injection Platform

    Title: Multimodal Imaging of Suprachoroidal Injections: A Retina Surgeon's Perspective

    Lead Author: Seenu Hariprasad, MD

    Conclusions: Utilizing novel imaging modalities for ocular injections, three important treatment attributes were demonstrated: 1) acute opening of the suprachoroidal space; 2) circumferential, posterior spread of injectate; and 3) compartmentalization of injectate to posterior tissues away from anterior and corneal tissues. These characterizations support suprachoroidal injections to target affected tissue layers in chorioretinal disorders for potential efficacy benefits, while compartmentalizing therapy away from unaffected tissues for potential safety benefits.

    Title: Safety of the Suprachoroidal Injection Procedure Utilizing SCS Microinjector® across Three Retinal Disorders

    Lead Author: Shree Kurup, MD, FACP

    Conclusions: In this analysis, safety data from the day of the procedure was compiled from eight clinical trials where suprachoroidal injections were performed across three disease states, including non-infectious uveitis, diabetic macular edema, and retinal vein occlusion. Analysis included a total of 621 patients who received one or more suprachoroidal injections. Importantly, rare but serious adverse events (SAEs) that are known to occur with intraocular injection were assessed, and there were no SAEs involving lens injury, suprachoroidal hemorrhage, or endophthalmitis in any patient receiving one or more suprachoroidal injections. In these eight clinical trials, the safety profile of suprachoroidal injections was comparable to intravitreal injections alone for events occurring during or on the same day as the injection procedure. The results from the retrospective analysis demonstrated the robustness of the suprachoroidal injection regardless of indication.

    Current Anti-VEGF Treatment Outcomes, Treatment Burden, and Unmet Need

    Title: Anti-VEGF Outcomes in RVO-Related Macular Edema Compared to nAMD and DME: Greater 1-Year Visual Gain but Larger Gap versus Respective Randomized Trials: A Real-World Analysis of 93,756 Patient Eyes

    Lead Author: Thomas Ciulla, MD

    Conclusions: In this study, real world anti-VEGF treatment outcomes were compared between wet AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO) associated macular edema. In this analysis, 93,756 patient eyes were assessed from de-identified medical records from hundreds of retina specialists across the United States. The assessment found that "real world" RVO patients experienced a modest gain in visual acuity (VA) with anti-VEGF treatment, and that injection frequency plays a large role in this outcome. It was found that an inverse relationship existed between outcomes and baseline VA, with the better baseline VA resulting in an increased risk of VA loss, reflecting a ceiling effect. The analysis showed that "real world" RVO patients experienced greater 1-year VA gain than "real world" wet AMD and DME patients, but exhibited a larger gap compared to respective randomized controlled trials. Current anti-VEGF therapies are associated with significant treatment burden for patients, families, and the health care system; there remains significant unmet need for more effective therapy with durability to address this treatment burden.

    CLS-TA (XIPERE™) and Uveitic Macular Edema

    Title: Post Hoc Analysis of Suprachoroidal CLS-TA versus Rescue Therapies for Uveitic Macular Edema: Safety and Visual Function

    Lead Author: Eric Suhler, MD

    Conclusions: Potential benefits of suprachoroidal delivery were explored in this analysis. CLS-TA is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration in the treatment of macular edema associated with uveitis. In this post hoc analysis, unrescued CLS-TA subjects experienced statistically significant greater reduction in central subfield thickness (CST) and tended towards greater improvement in best corrected visual acuity (BCVA) compared with control subjects rescued with therapies reflecting current clinical treatment. Suprachoroidally administered CLS-TA also appeared to be associated with a lower incidence of intraocular pressure (IOP)-related safety findings. This post hoc analysis provides a comparison of CLS-TA to a "real world" mix of rescue treatments, and corroborates the pre-specified endpoints of the Phase 3 PEACHTREE study.

    Title: Systemic Therapy and Efficacy of CLS-TA: Results from the Phase 3 PEACHTREE Clinical Trial

    Lead Author: Phoebe Lin, MD, PhD

    Conclusions: This analysis explored the potential impact of systemic immunomodulatory therapy on outcomes for CLS-TA treatment of uveitic macular edema. For this post hoc analysis, subjects were classified into two groups: those who did or did not receive systemic immunomodulatory therapy during the baseline visit. The benefit of suprachoroidally injected CLS-TA versus the control in treating macular edema associated with non-infectious uveitis was noted regardless of administration of systemic therapy at baseline, and these results corroborate the prespecified study analyses in PEACHTREE.

    Title: OCT Anatomic and Temporal Biomarkers in Uveitic Macular Edema

    Lead Author: Dilraj S. Grewal, MD

    Conclusions: There is limited information on longitudinal structure-functional correlations in uveitic macular edema. In clinical practice, physicians often base treatment decisions on both BCVA and optical coherence tomography (OCT) assessment.  This study assessed these relationships, focusing on baseline anatomic features with potential prognostic value for visual response in a post hoc analysis of 198 eyes with non-infectious uveitis. The analysis showed clinically relevant relationships between BCVA and OCT anatomic and temporal features. Anatomic response may precede visual response in uveitic macular edema.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effects with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. CLS-AX is currently in a Phase 1/2a clinical trial and additional information can be found on https://clinicaltrials.gov (NCT04626128).

    About Clearside's Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector®

    Clearside's patented, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company's unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is composed of a syringe and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, within a custom-designed hub that optimizes insertion and suprachoroidal administration of drugs.

    About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)

    XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye that is being investigated for the treatment of macular edema associated with uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (TSX:BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and an exclusive option for Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health's affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

    About PEACHTREE

    PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, and compared XIPERE dosed every 12 weeks to sham control. The PEACHTREE trial met its primary endpoint, with 47% of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16% of patients in the sham control arm (p<0.001), using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing. All key secondary and additional endpoints of the PEACHTREE trial were also achieved.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development and the potential benefits of CLS-TA and therapies using Clearside's SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



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    View Full Article Hide Full Article
  8. ALPHARETTA, Ga., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the first patients have been enrolled in its Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD). Clinical sites, all based in the United States, are activated and currently screening wet AMD patients for this Phase 1/2a trial, known as OASIS, involving CLS-AX, a proprietary suspension of axitinib for suprachoroidal injection.

    "The enrollment of the first patients for our OASIS trial…

    ALPHARETTA, Ga., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the first patients have been enrolled in its Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD). Clinical sites, all based in the United States, are activated and currently screening wet AMD patients for this Phase 1/2a trial, known as OASIS, involving CLS-AX, a proprietary suspension of axitinib for suprachoroidal injection.

    "The enrollment of the first patients for our OASIS trial is a key milestone for Clearside as we execute our strategy to expand our ophthalmology pipeline with innovative and relevant opportunities targeting critical medical needs through the suprachoroidal space (SCS®)," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "We believe that axitinib, a small molecule tyrosine kinase inhibitor (TKI), could provide safety and efficacy comparable to, or better than, current standard of care. And by delivering axitinib as a suspension into the suprachoroidal space using our in-office, non-surgical SCS Microinjector®, we may potentially extend the duration of therapeutic action and reduce or relieve the profound treatment burden for wet AMD patients. We expect data from our first cohort of patients in mid-2021."

    OASIS is a Phase 1/2a open-label, dose-escalation study in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection. Eligible patients are those who demonstrate stable visual acuity following two or more previous injections with an intravitreal anti-VEGF agent. Enrolled patients initially receive aflibercept at the first visit followed by a single dose of CLS-AX at the second visit one month later. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for the three months following the administration of CLS-AX, and secondary endpoints will evaluate the pharmacokinetics, visual function, ocular anatomy, and the need for additional treatment with intravitreal aflibercept during the three month period.

    The study design consists of 3 cohorts of 5 patients each (n=15). Cohort 1 participants will receive the lowest dose, 0.03 mg of axitinib delivered via suprachoroidal injection. Dose escalation will then proceed following review of the safety data by the Safety Monitoring Committee and their recommendation to advance to the next higher dose cohort. Additional information on the Phase 1/2a trial can be found on https://clinicaltrials.gov (NCT04626128).

    In preclinical studies, CLS-AX delivered suprachoroidally was observed to be well tolerated and showed significant ocular tissue concentrations over time. These characteristics, if demonstrated clinically, may support the potential for suprachoroidal axitinib to reduce or relieve the treatment burden for patients suffering from wet AMD.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effects with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD. CLS-AX is currently in a Phase 1/2a clinical trial and additional information can be found on https://clinicaltrials.gov (NCT04626128).

    About Clearside's Suprachoroidal Space (SCS®) Injection Platform

    Clearside's patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. Clearside's unique platform is inherently flexible and intended to work with certain established medications, new formulations of small molecule medicines, as well as future innovations such as gene therapy.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and the timing of data from the Phase 1/2a clinical trial for CLS-AX in wet AMD. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



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  9. ALPHARETTA, Ga., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that it has entered into a securities purchase agreement with institutional investors and certain existing stockholders, providing for the purchase and sale of 4,209,050 shares of common stock at a price of $2.851 per share, priced at-the-market under Nasdaq rules based on the five-day average closing price of the common stock, in a registered direct offering, resulting in total gross proceeds of approximately $12.0 million, before deducting the placement agent's fees and other…

    ALPHARETTA, Ga., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that it has entered into a securities purchase agreement with institutional investors and certain existing stockholders, providing for the purchase and sale of 4,209,050 shares of common stock at a price of $2.851 per share, priced at-the-market under Nasdaq rules based on the five-day average closing price of the common stock, in a registered direct offering, resulting in total gross proceeds of approximately $12.0 million, before deducting the placement agent's fees and other estimated offering expenses.

    The offering is expected to close on or about January 8, 2021, subject to the satisfaction of customary closing conditions.

    Roth Capital Partners is acting as the sole placement agent for the offering.

    The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-238128) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 8, 2020, amended on May 19, 2020 and declared effective by the SEC on May 22, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for Clearside, including statements about the closing of the offering and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the offering on the anticipated terms or at all, uncertainties inherent in the initiation of future clinical trials and such other factors as are set forth in the risk factors detailed in Clearside's Annual Report on Form 10-K filed with the SEC on March 13, 2020, Clearside's Quarterly Report on Form 10-Q filed with the SEC on November 10, 2020 and other filings with the SEC under the heading "Risk Factors." In addition, the forward-looking statements included in this press release represent Clearside's views as of the date hereof. Clearside anticipates that subsequent events and developments will cause Clearside's views to change. However, while Clearside may elect to update these forward-looking statements at some point in the future, Clearside specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Clearside's views as of any date subsequent to the date hereof.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



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    View Full Article Hide Full Article
  10. ALPHARETTA, Ga., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting.

    Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data…

    ALPHARETTA, Ga., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting.

    Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data described in this paper demonstrate that suprachoroidal injection was well accepted by physician-investigators, and that the device and procedure may accommodate a wide range of anatomic and demographic variables. These data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapies.

    "Reflecting on the past year, I am grateful to our team and the numerous physicians and researchers who have delivered 33 presentations on our assets and suprachoroidal space (SCS®) injection platform during 2020," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "In addition to our conference presentations, we have placed four publications in peer reviewed journals to further educate the medical community on our clinical progress. This coverage and attention on our programs have established Clearside as the leader in suprachoroidal delivery. We look forward to continuing to advance our suprachoroidal delivery programs with data expected in 2021 from our CLS-AX (axitinib injectable suspension) Phase 1/2a clinical trial, and our integrin inhibitor preclinical studies."

    Dr. Ciulla continued, "In addition to our internal progress, we are pleased with the advancements of our clinical development partners. This weekend at the AAO conference, suprachoroidal delivery was featured by our gene therapy partner, REGENXBIO, as well as in a late breaking presentation from Aura Biosciences in choroidal melanoma. Both of these companies are using our SCS Microinjector® to deliver their assets into the suprachoroidal space."

    Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)

    Authors: Robert Bhisitkul; Viral Kansara; Thomas Ciulla

    Conclusions:

    CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection. Axitinib has intrinsic high potency and pan-VEGF inhibition through receptor blockade. In pharmacokinetic studies, CLS-AX demonstrated prolonged duration. The U.S. Food and Drug Administration has accepted Clearside's Investigational New Drug Application and a Phase 1/2a clinical trial in wet age-related macular degeneration (wet AMD) is expected to initiate by the end of 2020.

    Title: Systemic Therapy and Efficacy of CLS-TA: Results from the Phase 3 PEACHTREE Clinical Trial

    Authors: Quan Nguyen; Thomas Ciulla

    Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. The visual acuity and macular edema improvements associated with suprachoroidally injected CLS-TA versus the control in treating macular edema associated with noninfectious uveitis, was noted regardless of administration of systemic therapy at baseline.

    About Clearside's Suprachoroidal Space (SCS®) Injection Platform

    Clearside's patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. Clearside's unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

    About XIPERE (triamcinolone acetonide suprachoroidal injectable suspension)

    XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health") (TSX:BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health's affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of initiation of and data from the Phase 1/2a clinical trial for CLS-AX in wet AMD, as well as the timing of data from preclinical studies in Clearside's integrin inhibitor program. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.



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  11. ALPHARETTA, Ga., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Management will present a company overview at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020 at 8:40 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that…

    ALPHARETTA, Ga., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Management will present a company overview at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020 at 8:40 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  12. - Initiation of Phase 1/2a Trial of CLS-AX (axitinib injectable suspension) for Wet Age-Related Macular Degeneration Expected by Year-End 2020 -
    - Phase 2 Trials Using SCS Microinjector®Ongoing by Gene Therapy and Oncology Partners -
    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the third quarter ended September 30, 2020 and provided a corporate update on key initiatives.

    "Over the last 15 months, we have been focused…

    - Initiation of Phase 1/2a Trial of CLS-AX (axitinib injectable suspension) for Wet Age-Related Macular Degeneration Expected by Year-End 2020 -

    - Phase 2 Trials Using SCS Microinjector® Ongoing by Gene Therapy and Oncology Partners -

    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the third quarter ended September 30, 2020 and provided a corporate update on key initiatives.

    "Over the last 15 months, we have been focused on implementing our strategy of building an internal research and development pipeline and establishing targeted external clinical development and commercial collaborations in the suprachoroidal space," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "We are making excellent progress on our internal and external programs and expect to have three novel therapeutic assets delivered via our SCS Microinjector® in four clinical trials by the end of this year. We expect this momentum to continue into 2021 with key catalyst events including the potential U.S. Food and Drug Administration approval of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) and initial data from our Phase 1/2a CLS-AX clinical trial in wet age-related macular degeneration (wet AMD). We also plan to advance our preclinical programs and look forward to initial clinical data readouts from our collaboration partners."

    Recent Key Highlights

    • Clearside's adeno-associated virus (AAV)-based gene therapy partner, REGENXBIO, dosed the first patient in its Phase 2 clinical trial, entitled AAVIATE, to evaluate the suprachoroidal delivery of RGX-314, an AAV gene therapy, using Clearside's SCS Microinjector for the treatment of wet AMD. REGENXBIO expects to complete enrollment of the first cohort by the end of 2020, and report initial safety data from the first cohort in early 2021.
    • REGENXBIO recently announced that its Phase 2 trial, ALTITUDE, to evaluate the targeted, in-office suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy (DR), is active. REGENXBIO expects to begin enrolling patients by the end of 2020 and plans to report interim data from this trial in 2021.
    • Clearside's ophthalmic oncology partner, Aura Biosciences, dosed the first patient in its Phase 2 clinical trial evaluating the safety and efficacy of suprachoroidal administration of AU-011 as a potential first-line treatment for patients with primary choroidal melanoma. Aura is using Clearside's SCS Microinjector to deliver AU-011 into the suprachoroidal space (SCS®).
    • Three new Clearside patents were issued in the United States and Europe, including a U.S. patent that covers Clearside's SCS Microinjector for the suprachoroidal administration of axitinib (CLS-AX), and two European patents related to suprachoroidal administration of any therapeutic agent and suprachoroidal administration of triamcinolone.
    • Multiple posters and oral presentations on Clearside's pipeline targeting the suprachoroidal space and its proprietary SCS Microinjector were delivered at the virtual 53rd Annual Scientific Meeting of The Retina Society.
    • Data from the Clearside's Phase 2 clinical trial in diabetic macular edema (DME) was published in Ophthalmology Retina. The trial, entitled TYBEE, evaluated the investigational suprachoroidally injected drug XIPERE when used with intravitreally administered aflibercept in patients with DME over a 6-month evaluation period. This early data suggest a potential role for XIPERE in reducing treatment burden for DME patients.
    • Data was published on the clinical characterization of the suprachoroidal injection procedure across three retinal disorders in Translational Vision Science and Technology, a journal of the Association for Research in Vision and Ophthalmology. The data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapeutics.

    Upcoming Events and Projected Milestones

    • Initiation of a Phase 1/2a clinical trial by the end of 2020 to assess safety and tolerability of CLS-AX administered via suprachoroidal injection in wet AMD with initial safety data from the first cohort expected in mid-2021.
    • AAV gene therapy partner, REGENXBIO, expects to report initial safety data from the first suprachoroidal cohort of its AAVIATE trial in wet AMD in early 2021 and interim data from its ALTITUDE trial in DR in 2021.
    • Data presentations on Clearside's programs will be made at the American Academy of Ophthalmology 2020 Annual Meeting which will be held virtually from Friday, November 13, 2020 through Sunday, November 15, 2020.
    • Clearside's management team will present at two virtual investor events: Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17, 2020, and the JMP Securities Wet AMD Call on Friday, November 20, 2020.
    • XIPERE New Drug Application (NDA) resubmission is targeted for no later than the first half of 2021.

    Third Quarter 2020 Financial Results

    Clearside's license revenue for the third quarter of 2020 was $3.4 million, compared to $141,000 for the third quarter of 2019. The $3.3 million increase was primarily attributable to the receipt of a partner milestone payment upon the initiation of a Phase 2 clinical trial using Clearside's SCS Microinjector.

    Research and development expenses for the third quarter of 2020 were $3.5 million, compared to $2.7 million for the third quarter of 2019. The $0.8 million increase was primarily attributable to increased expenses related to preparation for initiation of the CLS-AX Phase 1/2a clinical trial and costs related to drug manufacturing for XIPERE.

    General and administrative expenses for the third quarter of 2020 were $2.4 million, compared to $3.8 million for the third quarter of 2019. The $1.4 million decrease was primarily attributable to reduced marketing-related expenses resulting from the out-licensing of XIPERE commercialization.

    Net loss for the third quarter of 2020 was $2.4 million, or $0.05 per share of common stock, compared to a net loss of $6.5 million, or $0.17 per share of common stock, for the third quarter of 2019.

    As of September 30, 2020, Clearside's cash and cash equivalents totaled $14.8 million. Based on Clearside's current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the third quarter of 2021.

    Conference Call & Webcast Details

    Clearside's management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 3169417.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the timelines for resubmitting the NDA for and the potential approval of XIPERE, the timing of initiation of future clinical trials, the timing of receipt of data from clinical trials, future management and data presentations and Clearside's ability to fund its operations into the third quarter of 2021, including the receipt of potential milestone payments. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC on November 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    -Financial Tables Follow-



    CLEARSIDE BIOMEDICAL, INC.

    Selected Financial Data

    (in thousands, except share and per share data)

    (unaudited)

    Statements of Operations Data Three Months Ended

    September 30,
      Nine Months Ended

    September 30,
     
      2020  2019  2020  2019 
    License and other revenue $3,432  $141  $7,883  $231 
    Operating expenses:                
    Research and development  3,490   2,728   10,601   14,353 
    General and administrative  2,374   3,781   8,107   13,169 
    Total operating expenses  5,864   6,509   18,708   27,522 
    Loss from operations  (2,432)  (6,368)  (10,825)  (27,291)
    Other expense  (1)  (168)  (273)  (383)
    Net loss $(2,433) $(6,536) $(11,098) $(27,674)
    Net loss per share of common stock — basic and diluted $(0.05) $(0.17) $(0.24) $(0.75)
    Weighted average shares outstanding — basic and diluted  46,976,649   38,414,751   45,653,068   36,747,314 
                     



    Balance Sheet DataSeptember 30,  December 31, 
     2020  2019 
            
    Cash and cash equivalents$14,839  $22,595 
    Restricted cash 360   360 
    Total assets 17,405   26,776 
    Deferred revenue 5,000   5,000 
    Long-term debt (including current portion) 991   5,152 
    Total liabilities 9,281   15,619 
    Total stockholders' equity 8,124   11,157 

    Source: Clearside Biomedical, Inc.

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  13. ALPHARETTA, Ga., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its third quarter 2020 financial results will be reported on Tuesday, November 10, 2020 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959…

    ALPHARETTA, Ga., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its third quarter 2020 financial results will be reported on Tuesday, November 10, 2020 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 3169417.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

     

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    View Full Article Hide Full Article
  14. ALPHARETTA, Ga., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today several clinical data presentations were given at the virtual 53rd Annual Scientific Meeting of The Retina Society.

    Clearside also announced that data from the Company's Phase 2 clinical trial in diabetic macular edema (DME) was published in Ophthalmology Retina and can be accessed here. The trial, entitled TYBEE, evaluated the investigational drug XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) when used with intravitreally administered aflibercept…

    ALPHARETTA, Ga., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today several clinical data presentations were given at the virtual 53rd Annual Scientific Meeting of The Retina Society.

    Clearside also announced that data from the Company's Phase 2 clinical trial in diabetic macular edema (DME) was published in Ophthalmology Retina and can be accessed here. The trial, entitled TYBEE, evaluated the investigational drug XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) when used with intravitreally administered aflibercept in patients with DME over a 6-month evaluation period. This early data suggests that, if approved, XIPERE administered suprachoroidally, may have the potential to reduce treatment burden for some patients.

    "Our primary goal at Clearside is to deliver targeted treatments for patients suffering from serious retinal diseases," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "We are committed to educating physicians and the broader retinal community on our programs. The presentations delivered this week and the publication of our work in DME underscore the broad scope of development activities for our suprachoroidal injection platform. We continue to expand our pipeline with new opportunities and indications and look forward to starting our Phase 1/2a clinical trial with CLS-AX in neovascular age-related macular degeneration (wet AMD) this year."

    Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)

    Authors: David Brown; Viral Kansara; Thomas Ciulla

    Conclusions: CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity. There was sustained, high exposure observed in ocular tissues with the highest concentration found in the tissues of the sclera, choroid, and retinal pigment epithelium (RPE), followed by the retina. CLS-AX has intrinsic high potency, pan-VEGF inhibition through receptor blockade, and demonstrated prolonged duration observed in pharmacokinetic studies, as well as pharmacodynamic effect in multiple animal models. CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection and has the potential to be a bi-annual therapy for wet AMD.

    Title: Post Hoc Analysis of Clinical Suprachoroidal Injection Experience Across Indications

    Author: Chris Henry; faculty sponsor Amy Schefler; Cherry Wan; Barry Kapik; Colette Hall; Thomas Ciulla

    Conclusions: To date, this is the most robust aggregate dataset of clinical suprachoroidal injections with mounting evidence pointing to the potential reliability and consistency of the procedure. The results from the retrospective analysis demonstrated the robustness of the suprachoroidal injection regardless of indications. The two needle length options successfully accommodated for anatomical variations across patients.

    Title: Suprachoroidal Delivery of Small Molecule Suspensions and Nanoparticles

    Authors: Judy Kim; Viral Kansara; Thomas Ciulla 

    Conclusions: Delivery of small molecule suspensions may provide targeted, well-tolerated, and long-acting delivery of a wide variety of pharmacologic agents, including corticosteroids, tyrosine kinase inhibitors (TKIs), and complement inhibitors to the RPE, sclera and choroid. Preclinical models for these compounds were promising and based on the favorable clinical results of a small molecule corticosteroid for macular edema associated with noninfectious uveitis, further testing is warranted for these other molecules. Additionally, suprachoroidal delivery of DNA nanoparticle-based gene has potential as an office-based retinal gene therapy; and further testing is warranted.

    Title: Suprachoroidally delivered non-viral DNA nanoparticles transfect chorioretinal cells in non-human primates and rabbits

    Authors: Nancy Holekamp; Viral Kansara; Thomas Ciulla

    Conclusions: Suprachoroidal injections of DNA Nanoparticles may address several unmet needs in ocular gene delivery. DNA nanoparticles are relatively non-immunogenic compared to viral vector-based gene therapy, and suprachoroidal injection facilitates the potential for office-based repeat dosing with fewer safety risks compared to subretinal injection via pars plana vitrectomy surgery. In addition, DNA nanoparticles can transfer genes beyond the capacity of viral vectors, including those in common inherited retinal diseases (IRDs) such as Stargardt disease and Usher syndrome. Additional research evaluating suprachoroidal injection in non-human primates and delivery of a therapeutic transgene is needed.

    Title: Results from the Phase 3 PEACHTREE Clinical Trial: Systemic Therapy and the Efficacy of CLS-TA, a Post-Hoc Analysis

    Authors: Pauline Merrill; Thomas Ciulla

    Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. With respect to best corrected visual acuity (BCVA) and central subfield thickness (CST), CLS-TA showed a clinically meaningful relative benefit over control in patients receiving systemic immunosuppression and patients not receiving systemic immunosuppression.

    Title: Correlation of Best Corrected Visual Acuity and Central Subfield Thickness in Macular Edema Due to Retinal Vein Occlusion, Diabetic Retinopathy and Uveitis

    Authors: Michael Ip; Thomas Ciulla

    Conclusions: In this cohort of over 1,000 eyes, there were moderate baseline relationships between BCVA and CST in patients with macular edema (ME) due to retinal vein occlusion (RVO), diabetic macular edema (DME) and noninfectious uveitis. There were also moderate relationships between BCVA and CST across these disease states with respect to change from baseline to 6 months. These correlations provide context around the use of CST in clinical decision making.

    Title: Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Macular Edema Due to Retinal Vein Occlusion: An Analysis of 12,214 Eyes

    Authors: Thomas Ciulla; John Pollack; David Williams

    ConclusionsReal-world RVO patients with macular edema experience worse visual outcomes compared with patients in randomized controlled trials. Mean change in visual acuity (VA) correlated with treatment intensity at 1 year. Patients with better VA at presentation tended to be particularly vulnerable to vision loss.

    Copies of these presentations will be available on Clearside's website under the Publications & Presentations page here: https://www.clearsidebio.com/publications.htm.

    About Clearside's Suprachoroidal Space (SCS®) Injection Platform

    Clearside's patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The company's unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

    About XIPERE (triamcinolone acetonide suprachoroidal injectable suspension)

    XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health") (TSX:BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health's affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of the Phase 1/2a clinical trial for CLS-AX in wet AMD. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

     

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  15. ALPHARETTA, Ga., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its licensing partner, Aura Biosciences, has dosed the first patient in its Phase 2 clinical trial evaluating the safety and efficacy of suprachoroidal administration of AU-011 as a potential first-line treatment for patients with primary choroidal melanoma. Aura is using Clearside's SCS Microinjector® to deliver AU-011 into the suprachoroidal space (SCS®).

    Aura also announced that AU-011 passed the Safety Review for the first dose escalation cohort which demonstrated…

    ALPHARETTA, Ga., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its licensing partner, Aura Biosciences, has dosed the first patient in its Phase 2 clinical trial evaluating the safety and efficacy of suprachoroidal administration of AU-011 as a potential first-line treatment for patients with primary choroidal melanoma. Aura is using Clearside's SCS Microinjector® to deliver AU-011 into the suprachoroidal space (SCS®).

    Aura also announced that AU-011 passed the Safety Review for the first dose escalation cohort which demonstrated favorable safety data with no safety findings and no adverse events noted. Aura's preclinical data on suprachoroidal injection of AU-011 presented at the Association for Research in Vision and Ophthalmology conference can be accessed here.

    "With this trial initiation, we are on track to have three product candidates delivered via our SCS Microinjector in four clinical trials this year," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "Choroidal melanoma is a rare and aggressive type of eye cancer and is the most common primary intraocular tumor in adults. Aura is a leader in their field and there is an unmet need for a new first-line treatment option for early stage choroidal melanoma. We are excited by ocular oncologists' interest in suprachoroidal delivery and look forward to Aura's continued progress." 

               

    About Clearside's SCS Microinjector®

    Clearside's patented, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is composed of a syringe and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, within a custom-designed hub that optimizes insertion and suprachoroidal administration of drugs.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development and the potential benefits of therapies using Clearside's SCS Microinjector® and the timing of data presentations by Clearside's licensing partner. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

     

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  16. ALPHARETTA, Ga., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer and Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer will present a company overview at the Virtual H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020 at 11:30 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be…

    ALPHARETTA, Ga., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer and Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer will present a company overview at the Virtual H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020 at 11:30 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  17. ALPHARETTA, Ga., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its licensing partner, REGENXBIO Inc. (NASDAQ:RGNX), has dosed the first patient in its Phase 2 clinical trial to evaluate the suprachoroidal delivery of RGX-314, an adeno-associated virus (AAV) gene therapy, using Clearside's SCS Microinjector® for the treatment of wet age-related macular degeneration (wet AMD).

    "We are pleased to see the progress made by REGENXBIO using our proprietary SCS Microinjector® for the suprachoroidal delivery of its innovative gene therapy…

    ALPHARETTA, Ga., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its licensing partner, REGENXBIO Inc. (NASDAQ:RGNX), has dosed the first patient in its Phase 2 clinical trial to evaluate the suprachoroidal delivery of RGX-314, an adeno-associated virus (AAV) gene therapy, using Clearside's SCS Microinjector® for the treatment of wet age-related macular degeneration (wet AMD).

    "We are pleased to see the progress made by REGENXBIO using our proprietary SCS Microinjector® for the suprachoroidal delivery of its innovative gene therapy into the back of the eye," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "Our targeted drug delivery approach has broad applicability utilizing proven compounds, novel small molecules, and gene therapy to deliver treatment in an office-based, non-surgical procedure. We believe this route of administration represents an important potential advancement in patient care."

    About Clearside's SCS Microinjector®

    Clearside's patented, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside's proprietary SCS Microinjector® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is composed of a syringe and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, within a custom-designed hub that optimizes insertion and suprachoroidal administration of drugs.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development and the potential benefits of therapies using Clearside's SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Primary Logo

    View Full Article Hide Full Article
  18. ALPHARETTA, Ga., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today the recent issuance of three additional patents in the United States and Europe.

    The United States Patent and Trademark Office (USPTO) recently granted patent number 10,722,396 to Clearside.  This patent covers Clearside's SCS Microinjector® for the suprachoroidal administration of axitinib (CLS-AX) and expires in 2034.

    The European Patent Office (EPO) issued two patents in the largest European markets. Patent number 2,563,429 expires in 2031 and covers a device for the suprachoroidal…

    ALPHARETTA, Ga., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today the recent issuance of three additional patents in the United States and Europe.

    The United States Patent and Trademark Office (USPTO) recently granted patent number 10,722,396 to Clearside.  This patent covers Clearside's SCS Microinjector® for the suprachoroidal administration of axitinib (CLS-AX) and expires in 2034.

    The European Patent Office (EPO) issued two patents in the largest European markets. Patent number 2,563,429 expires in 2031 and covers a device for the suprachoroidal administration of any therapeutic agent. Patent number 2,916,827 expires in 2033 and covers the use of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) and the treatment of uveitis and other posterior ocular diseases with triamcinolone acetonide.

    Clearside's 21 granted U.S. patents and its 20 granted European patents provide extensive coverage of the SCS Microinjector device, the use of the device, administration of any drug into the suprachoroidal space by injection, as well as specific product candidates.

    "Clearside is the market leader in suprachoroidal delivery, and the issuance of these patents in two of the largest world markets significantly strengthens the IP portfolio governing our proprietary SCS Microinjector and our product candidates," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "We are committed to broadening our global patent estate as we continue to expand our internal pipeline and increase patient access to innovative therapies. We look forward to achieving additional milestones by the end of 2020 as we and our partners expect to have three product candidates delivered via our SCS Microinjector in four clinical trials."

    About Clearside's Suprachoroidal Space (SCS®) Injection Platform

    Clearside's patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company's unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

    About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)

    XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and an exclusive option for Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health's affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding XIPERE, the potential benefits of CLS-AX and the SCS Microinjector, the anticipated timing of clinical trials conducted by Clearside's partners and the expected achievement of certain milestones. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 10, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  19. - IND Accepted by FDA for Suprachoroidal CLS-AX (axitinib injectable suspension) -
    - Expanded Internal Suprachoroidal Pipeline with Two New Preclinical Programs -
    - Engaged New Contract Manufacturer for XIPERE-
    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update on key initiatives.

    Key Highlights

    • The Investigational New Drug (IND) application for suprachoroidal…

    - IND Accepted by FDA for Suprachoroidal CLS-AX (axitinib injectable suspension) -

    - Expanded Internal Suprachoroidal Pipeline with Two New Preclinical Programs -

    - Engaged New Contract Manufacturer for XIPERE-

    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update on key initiatives.

    Key Highlights

    • The Investigational New Drug (IND) application for suprachoroidal CLS-AX (axitinib injectable suspension) was submitted as planned and accepted by the U.S. Food and Drug Administration (FDA).
    • Expanded the suprachoroidal development pipeline by initiating two new programs:
      • A non-viral vector gene therapy program ("therapeutic biofactory") designed to express and secrete anti-VEGF therapeutic protein after suprachoroidal administration of DNA nanoparticles containing the corresponding gene.
      • A preclinical development program utilizing suprachoroidal administration of an integrin inhibitor small molecule suspension.
    • Engaged a new contract manufacturing partner for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) to allow for a more efficient and predictable process for New Drug Application (NDA) resubmission and review.
    • Clearside's ophthalmic oncology partner, Aura Biosciences, presented preclinical research at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting regarding the ocular distribution and efficacy in a rabbit model of AU-011 utilizing Clearside's SCS Microinjector®. According to Aura, the data showed distribution of AU-011 in the suprachoroidal space (SCS®) and complete necrosis of tumors following laser activation of choroidal melanoma. Preclinical studies have been completed, and Aura expects to initiate a Phase 2 clinical trial evaluating suprachoroidal delivery of AU-011 during the third quarter of 2020.
    • Clearside's adeno-associated virus (AAV)-based gene therapy partner, REGENXBIO, announced that their Phase 2 clinical trial (AAVIATE) for RGX-314 for the treatment of wet AMD using suprachoroidal delivery is active, with enrollment expected to begin in the third quarter of 2020 and an interim data update from the first cohort expected by the end of 2020. REGENXBIO also expects to initiate a Phase 2 clinical trial for RGX-314 using suprachoroidal delivery in diabetic retinopathy in the second half of 2020.
    • In April 2020, Clearside and Bausch Health Companies Inc. and its leading global eye health business, Bausch + Lomb, amended their licensing agreement for the commercialization and development of XIPERE.
    • Experienced research and development executive, Nancy J. Hutson, Ph.D., was appointed to Clearside's Board of Directors.
    • A Scientific Advisory Board was established with highly respected and experienced retinal physicians who will provide input on new technology, preclinical programs and clinical development.
    • Multiple posters and oral presentations on Clearside's pipeline targeting the suprachoroidal space and its proprietary SCS Microinjector were delivered at the 2020 Virtual Annual Meetings of ARVO and the American Society of Retina Specialists (ASRS).

    Upcoming Events and Projected Milestones

    • Initiation of a Phase 1/2a clinical trial by the end of 2020 to assess safety and tolerability of CLS-AX in neovascular age-related macular degeneration (wet AMD) with initial safety data from the first cohort expected in mid-2021.
    • XIPERE NDA resubmission targeted in the first half of 2021.
    • Data presentations on Clearside's programs will be made at the Retina Society 2020 Annual Meeting which will be held virtually.
    • Clearside's management team will present at two virtual investor conferences: 2020 Wedbush PacGrow Healthcare Conference and the H.C. Wainwright 22nd Annual Global Investment Conference.

    George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer, commented, "Over the past year, we have worked purposefully and diligently to reorient Clearside from a single product company to one that has multiple relevant and promising opportunities targeting the suprachoroidal space. We have made important progress in our key clinical and preclinical programs and we are positioning ourselves to have a strong year in 2021 with potential approval of XIPERE and initial patient data from our CLS-AX program."

    Dr. Lasezkay continued, "Our IND application for CLS-AX was accepted and we are preparing to initiate a Phase 1/2a trial in wet AMD later this year to assess the safety and tolerability of our proprietary suspension of axitinib delivered via our SCS Microinjector. We also continue to expand our internal suprachoroidal pipeline with two new preclinical programs: a ‘therapeutic biofactory' program which is our second, non-viral vector, suprachoroidal gene therapy preclinical program; and a small molecule preclinical  program utilizing a suprachoroidal integrin inhibitor suspension. We look forward to advancing our expanded internal development pipeline over the next year."

    "We have also engaged a new, U.S.-based contract manufacturing organization (CMO) for XIPERE, which we believe will allow for a more efficient and predictable process for NDA resubmission and review. We were recently notified by our previous CMO that it is no longer willing to serve as our commercial supplier for XIPERE. While this news was unexpected, we had proactively begun evaluating alternative manufacturers given previously disclosed delays due to manufacturing and facility issues. Therefore, we were able to quickly engage a new CMO and rapidly initiate manufacturing technology transfer activities," said Dr. Lasezkay.

    "This transition is a positive step forward to achieving XIPERE approval as the new CMO provides Clearside and our licensees with an experienced and reliable partner for the manufacture of registration batches and future commercial supplies of XIPERE, if approved. The new CMO has an established track record with respect to FDA inspections, has extensive experience with production of small molecule suspensions, steroids and ophthalmic products, and is prepared to move quickly to produce the necessary batches of XIPERE to support our NDA resubmission. We expect to resubmit the XIPERE NDA as quickly as possible after the transfer of the manufacturing process has been completed and the required three-month stability data is generated. Although we are still in the process of finalizing the timelines with the new CMO, our current expectation is that resubmission will occur no later than the first half of 2021," Dr. Lasezkay concluded.

    Second Quarter 2020 Financial Results

    Clearside's license revenue for the second quarter of 2020 was $0.4 million, compared to $45,000 for the second quarter of 2019.

    Research and development expenses for the second quarter of 2020 were $3.3 million, compared to $0.7 million for the second quarter of 2019. The $2.6 million increase was attributable to vendor credits of $2.6 million received in the second quarter of 2019 upon reconciliation of final costs from the closure of two late-stage clinical trials.

    General and administrative expenses for the second quarter of 2020 were $2.6 million, compared to $5.0 million for the second quarter of 2019. The $2.4 million decrease was primarily attributable to reduced employee and marketing expenses resulting from executive management changes and the out-licensing of XIPERE commercialization.

    Net loss for the second quarter of 2020 was $5.8 million, or $0.13 per share of common stock, compared to a net loss of $5.7 million, or $0.15 per share of common stock, for the second quarter of 2019.

    As of June 30, 2020, Clearside's cash and cash equivalents totaled $15.1 million. During the second quarter of 2020, due to various restrictions and other limiting covenants, the Company elected to make an early payoff of its outstanding $5.0 million principal balance under its bank loan, plus $0.3 million reflecting the final payment fee and accrued interest. Based on Clearside's current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the second quarter of 2021.

    Conference Call & Webcast Details

    Clearside's management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 2290836. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the timelines for resubmitting the NDA for XIPERE, initiation of future clinical trials, future management and data presentations, manufacturing expectations with respect to XIPERE and Clearside's ability to fund its operations into the second quarter of 2021, including the receipt of potential milestone payments. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 to be filed with the SEC on August 10, 2020 and Clearside's other Periodic Reports filed with the SEC.. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    -Financial Tables Follow-

     
    CLEARSIDE BIOMEDICAL, INC.
    Selected Financial Data
    (in thousands, except share and per share data)
    (unaudited)
     
    Statement of Operations DataThree Months Ended

    June 30,
      Six Months Ended

    June 30,
     
     2020  2019  2020  2019 
    License and other revenue$354  $45  $4,451  $90 
    Operating expenses:               
    Research and development 3,300   658   7,111   11,625 
    General and administrative 2,611   5,004   5,733   9,388 
    Total operating expenses 5,911   5,662   12,844   21,013 
    Loss from operations (5,557)  (5,617)  (8,393)  (20,923)
    Other expense (197)  (117)  (272)  (215)
    Net loss$(5,754) $(5,734) $(8,665) $(21,138)
    Net loss per share of common stock — basic and diluted$(0.13) $(0.15) $(0.19) $(0.59)
    Weighted average shares outstanding — basic and diluted 45,214,500   37,636,053   44,984,005   35,899,777 
                    



        
    Balance Sheet DataJune 30, December 31,
     2020 2019
          
    Cash and cash equivalents$15,071 $22,595
    Restricted cash 360  360
    Total assets 17,738  26,776
    Deferred revenue 5,000  5,000
    Long-term debt (including current portion) 991  5,152
    Total liabilities 10,451  15,619
    Total stockholders' equity 7,287  11,157

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  20. - Initiation of CLS-AX Phase 1/2a Clinical Trial in Wet AMD Targeted by Year-End 2020 -

    ALPHARETTA, Ga., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for CLS-AX (axitinib injectable suspension), enabling initiation of a Phase 1/2a clinical trial of CLS-AX in neovascular age-related macular degeneration (wet AMD) patients by the end of 2020.

    "The FDA's acceptance of our IND submission for CLS-AX is a significant achievement for…

    - Initiation of CLS-AX Phase 1/2a Clinical Trial in Wet AMD Targeted by Year-End 2020 -

    ALPHARETTA, Ga., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for CLS-AX (axitinib injectable suspension), enabling initiation of a Phase 1/2a clinical trial of CLS-AX in neovascular age-related macular degeneration (wet AMD) patients by the end of 2020.

    "The FDA's acceptance of our IND submission for CLS-AX is a significant achievement for Clearside and demonstrates our ability to successful move another internally-developed program into the clinic," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "As a tyrosine kinase inhibitor (TKI), axitinib has demonstrated pan-VEGF inhibition in independent studies and may have the potential to be more efficacious than current, more narrowly focused VEGF inhibition approaches. In our internal preclinical studies, CLS-AX delivered through suprachoroidal injection was well tolerated and showed durability over several months, providing Clearside the opportunity to potentially reduce treatment burden and address a primary need for wet AMD patients. We look forward to initiating clinical work by the end of 2020."

    The Phase 1/2a clinical trial in wet AMD patients is expected to be an open-label, dose-escalation study to assess the safety and tolerability of single doses of CLS-AX administered through suprachoroidal injection following two or more prior treatments with an intravitreal anti-VEGF agent.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the timing of initiating the Phase 1/2a clinical trial for CLS-AX in wet AMD and the potential benefits of CLS-AX and the SCS Microinjector. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q filed with the SEC on May 8, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  21. ALPHARETTA, Ga., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer and Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer will present a company overview at the 2020 Wedbush PacGrow Healthcare Virtual Conference on August 11, 2020 at 9:10 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months…

    ALPHARETTA, Ga., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer and Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer will present a company overview at the 2020 Wedbush PacGrow Healthcare Virtual Conference on August 11, 2020 at 9:10 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  22. ALPHARETTA, Ga., July 30, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its second quarter 2020 financial results will be reported on Monday, August 10, 2020 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international…

    ALPHARETTA, Ga., July 30, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its second quarter 2020 financial results will be reported on Monday, August 10, 2020 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 2290836.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

    Primary Logo

    View Full Article Hide Full Article
  23. ALPHARETTA, Ga., July 27, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple posters and oral presentations on Clearside's pipeline and its proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) were delivered at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting.

    "Clearside continues to stay top-of-mind with the ophthalmic and retina communities as our clinical development pipeline and suprachoroidal delivery system are featured at prominent medical meetings," said Thomas A. Ciulla, M.D., MBA…

    ALPHARETTA, Ga., July 27, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple posters and oral presentations on Clearside's pipeline and its proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) were delivered at the American Society of Retina Specialists (ASRS) 2020 Virtual Annual Meeting.

    "Clearside continues to stay top-of-mind with the ophthalmic and retina communities as our clinical development pipeline and suprachoroidal delivery system are featured at prominent medical meetings," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "This year, ASRS held a successful annual meeting with a virtual format that allowed for easy access to presentations and interactions with treating physicians. We look forward to keeping our stakeholders appraised of our pipeline developments as we advance our programs."

    CLS-AX (axitinib injectable suspension)

    Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)

    Authors: David Brown; Thomas Ciulla; Viral Kansara

    Conclusions: CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity. There was sustained, high exposure observed in ocular tissues with the highest concentration found in the tissues of the sclera, choroid, and retinal pigment epithelium (RPE), followed by the retina. CLS-AX demonstrated intrinsic high potency, pan-VEGF inhibition through receptor blockade, prolonged duration observed in pharmacokinetic studies, and a pharmacodynamic effect in multiple animal models. CLS-AX may be a targeted therapy for affected tissue layers via suprachoroidal injection and has the potential to be a bi-annual therapy for nAMD.

    Suprachoroidal Delivery

    Title: Suprachoroidal Delivery of Suspensions of Tyrosine Kinase Inhibitor, Complement Inhibitor, and Corticosteroid: Preclinical and Clinical Correlates

    Authors: Steven Yeh; Thomas Ciulla, Viral Kansara

    Conclusions: Suprachoroidal injection of suspensions of tyrosine kinase inhibitor (TKI), complement inhibitor, and triamcinolone acetonide demonstrated prolonged therapeutic levels with the potential for a sustained release and high bioavailability. Suprachoroidal injection showed compartmentalization with the potential to minimize adverse effects. Preclinical attributes correlated to clinical trial outcomes for steroids. Further study of TKI and complement factors suspensions are warranted.

    Title: Post hoc Analysis of Clinical Suprachoroidal Injection Experience Across Retinal Disease Indications

    Authors: Christopher R. Henry; Cherry Wan; Barry Kapik

    Conclusions: To date, this is the largest aggregate dataset of clinical suprachoroidal injections with mounting evidence pointing to the reliability and consistency of the procedure. The two needle length options successfully accommodate for anatomical variations across patients and retinal disease states. Correlations were found between needle length, gender and injection quadrant.

    Title: Post Hoc Analysis of Clinical Suprachoroidal Injection Experience for Non-infectious Uveitis

    Authors: Shree Kurup; Cherry Wan, Barry Kapik

    Conclusions: Overall, the two needles provided in the kit accommodated patient ocular anatomic and demographic variation. Suprachoroidal injections showed consistency across demographics and ocular characteristics. Small correlations existed between needle length used and age, injection quadrant, and disease duration. Supratemporal injection quadrant correlations were particularly consistent with previously reported anatomic variation by quadrant.

    Macular Edema associated with Uveitis

    Title: Variations in Intraocular Pressure Following Administration of Suprachoroidal Triamcinolone Acetonide Suspension (CLS-TA):

    Results from the Phase 3 PEACHTREE Clinical Trial for Uveitic Macular Edema


    Authors: Quan Dong Nguyen

    Conclusions: In the trial, the primary endpoint was met, with ~47% of patients gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Suprachoroidally injected CLS-TA significantly improved vision and macular edema in noninfectious uveitis at all anatomical locations. There were no serious adverse events attributable to CLS-TA. Low rates of elevated intraocular pressure (IOP) and cataracts were observed, and the cataract rate was similar to the control arm.

    Title: Results from the Phase 3 PEACHTREE Clinical Trial: Systemic Therapy and the Efficacy of CLS-TA, a Post-Hoc Analysis

    Authors: Ashvini Reddy; Thomas A. Ciulla

    Conclusions: These results corroborate the prespecified study analyses in PEACHTREE. The benefit of CLS-TA over the control in treating macular edema associated with non-infectious uveitis was noted regardless of administration of systemic therapy at baseline.

    Macular Edema

    Title: "Real World" Outcomes of Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Retinal Vein Occlusion

    Authors: Thomas A. Ciulla

    Conclusions: Real-world retinal vein occlusion (RVO) patients with macular edema experience worse visual outcomes compared with patients in randomized controlled trials. Mean change in visual acuity correlates with treatment intensity at one year. Patients with better visual acuity at presentation tend to be particularly vulnerable to vision loss.

    Title: Correlation of Best Corrected Visual Acuity and Central Subfield Thickness in Macular Edema Due to Retinal Vein Occlusion, Diabetic Retinopathy and Noninfectious Uveitis

    Authors: Michael Ip; Thomas A Ciulla

    Conclusions: There were moderate correlations between best corrected visual acuity (BCVA) and central subfield thickness (CST) in all diseases at baseline and for change at week 24. These correlations provide context around the use of CST in clinical decision making and visual recovery.

    Copies of these presentations will be available on Clearside's website under the Publications & Presentations page here: https://www.clearsidebio.com/publications.htm.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have showed pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

    About Clearside's Suprachoroidal Space (SCS®) Injection Platform

    Clearside's patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company's unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX, CLS-TA and the SCS Microinjector. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q filed with the SEC on May 8, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

    Primary Logo

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  24. – Preclinical CLS-AX data demonstrates a potentially long-acting therapy for neovascular age-related macular degeneration –

    – Evidence supports the reliability, repeatability, and consistency of Clearside's suprachoroidal injection procedure for chorio-retinal diseases using patented SCS Microinjector®

    ALPHARETTA, Ga., June 17, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and its proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) are available online at the ARVO…

    – Preclinical CLS-AX data demonstrates a potentially long-acting therapy for neovascular age-related macular degeneration –

    – Evidence supports the reliability, repeatability, and consistency of Clearside's suprachoroidal injection procedure for chorio-retinal diseases using patented SCS Microinjector®

    ALPHARETTA, Ga., June 17, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and its proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) are available online at the ARVO 2020 Meeting.

    Due to COVID-19, the ARVO 2020 Annual Meeting is being held virtually.  As a result, abstracts are available online and presentations can be accessed on the ARVOLearn website

    "Clearside's pipeline and our proprietary suprachoroidal delivery system were strongly represented at ARVO this year with thirteen distinct presentations," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. "Notably, CLS-AX, our proprietary suspension of axitinib delivered via our SCS Microinjector, demonstrated sustained, well-tolerated and targeted delivery of axitinib to the back of the eye in preclinical studies. In addition, CLS-AX showed inhibition of neovascularization and leakage, as well as durability.  With its intrinsic highly potent pan-VEGF inhibition through receptor blockade, CLS-AX has the potential to be an effective therapy for neovascular age-related macular degeneration (nAMD)."

    Dr. Ciulla continued, "Another area we are excited to explore, based on data presented at the conference, is complement inhibitors. Preclinical delivery of a complement inhibitor via our SCS Microinjector showed the agent was well tolerated, sustained high drug levels, and merits further studies in the development of long-acting small molecule complement inhibitors for dry AMD.  In addition, several presentations featuring delivery of agents via our patented SCS Microinjector continue to support the reliability, repeatability, and consistency of our procedure for the treatment of chorio-retinal diseases. The results continue to demonstrate the robustness of suprachoroidal injection across indications and that the two needle length options successfully accommodate for anatomical variations across patients."

    Dr. Ciulla concluded, "We are pleased with the progress of our partner, Aura Biosciences, with whom we have a worldwide licensing agreement for the use of our SCS Microinjector to deliver their proprietary drug candidates into the SCS for the potential treatment of certain ocular cancers, including choroidal melanoma. Aura presented preclinical research at ARVO regarding the ocular distribution and efficacy in a rabbit model of AU-011. According to Aura, the data showed excellent distribution of AU-011 in the SCS and complete necrosis of tumors following laser activation in a rabbit  model of choroidal melanoma. Further preclinical studies are currently ongoing, and Aura expects to initiate a Phase 2 clinical study evaluating suprachoroidal delivery of AU-011 during the third quarter of 2020."

    CLS-AX (axitinib injectable suspension) and Complement Inhibitors

    Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)

    Authors: Peter K Kaiser; Thomas Ciulla; Viral Kansara

    Conclusions: CLS-AX was well tolerated with durability in the suprachoroidal space. Results from laser choroidal neovascularization  studies corroborate other studies, showing inhibition of neovascularization in animal models. Given this pharmacodynamic effect, ability to directly target affected tissues, and intrinsic highly potent pan-VEGF inhibition through receptor blockade, CLS-AX has the potential to be a long-acting therapy for nAMD.

    Presentation: https://learning.arvo.org/diweb/catalog/launch/media/eid/5237422

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2768322&resultClick=1

    Title: Pharmacokinetics and Ocular Tolerability of Suprachoroidal CLS-AX (axitinib injectable suspension) in rabbits

    Authors: Leroy Muya; Viral Kansara; Thomas Ciulla

    Conclusions: Suprachoroidal CLS-AX provided sustained, safe and targeted delivery of axitinib to the back of the eye. Given the durability, intrinsic high potency and pan-VEGF inhibition, suprachoroidal CLS-AX has the potential to be a bi-annual therapy for nAMD.

    Presentation: https://learning.arvo.org/diweb/catalog/launch/media/eid/5257731

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2768760&resultClick=1

    Title: Suprachoroidal Delivery of Suspensions of Tyrosine Kinase Inhibitor, Complement Inhibitor, and Corticosteroid: Preclinical and Clinical Correlates 

    Authors: Debra A Goldstein; Thomas A Ciulla

    Conclusions: Suprachoroidal delivery of suspensions of tyrosine kinase inhibitor (TKI), complement inhibitor, and corticosteroid demonstrated prolonged therapeutic levels with the potential for sustained release and high bioavailability, and showed compartmentalization with the potential to minimize adverse effects. These attributes correlate to clinical trial outcomes for corticosteroid; further study of TKI and complement factors suspensions are warranted.

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2769326&resultClick=1

    Title: Ocular Pharmacokinetics and Safety of Suprachoroidal A01017, Small Molecule Complement Inhibitor, Injectable Suspension in Rabbits 

    Authors: Shelley E Hancock; Avinash Phadke; Viral Kansara; David Boyer; Jose Rivera; Christopher Marlor; Steven Podos; Jason Wiles; Rick McElheny; Thomas A Ciulla; Mingjun Huang; Mark Cartwright

    Conclusions: Suprachoroidal delivery of A01017 suspension, a highly potent complement factor D inhibitor that blocks alternative pathway activity, provided well tolerated, sustained high drug levels in the posterior segment in rabbits, and merits further studies in the development of long-acting small molecule complement inhibitors for dry AMD.

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2768184&resultClick=1

    Treatment Burden and Unmet Need in AMD and Macular Edema

    Title: Treatment Burden and Visual Outcomes in Neovascular Age-Related Macular Degeneration (AMD)  

    Authors: Saira Khanna; Rahul Komati; David Aaron Eichenbaum; Ishani Hariprasad; Thomas A Ciulla; Seenu Hariprasad

    Conclusions: Despite the varying durability of the different anti-VEGF agents, there is a positive correlation between the number of injections in 12-months and the change in mean best corrected visual acuity (BCVA) (ETDRS letters). While challenging in practice, frequent treatment regimens have benefits in terms of vision; however, this needs to be mitigated by real-world constraints.

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2769144&resultClick=1

    Title: Visual Acuity Outcomes and Anti-VEGF Intensity in Macular Edema due to RVO: A "Real World" Analysis in 12,214 Eyes

    Authors: Thomas A Ciulla

    Conclusions: Real-world retinal vein occlusion (RVO) patients with macular edema (ME) experience worse visual outcomes compared with patients in randomized controlled trials. Mean change in visual acuity (VA) correlates with treatment intensity at 1 year. Patients with better VA at presentation tend to be particularly vulnerable to vision loss.

    Presentation: https://learning.arvo.org/diweb/catalog/launch/media/eid/5256808

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2768105&resultClick=1

    Gene Therapy

    Title: Gene Therapy Biofactory: Mathematical Modeling of Pharmacokinetics

    Authors: Lucia Carichino; Giovanna Guidoboni; Viral Kansara; Thomas Ciulla; Alon Harris

    Conclusions: The model allowed the estimation of therapeutic protein levels in the retina and vitreous, and showed an aqueous humor level (AHL)-dependent increase of these levels. Future studies are needed to expand the model to account for the retina pigmented epithelium and choroid compartments that contribute to the production of the anti-VEGF protein in this biofactory approach, and whose levels are challenging to extract in the clinical setting. In the future, precision medicine aided by mathematical modeling could be employed after anterior chamber diagnostic testing of pathologic proteins, to select therapeutic options of different gene therapy biofactory approaches.

    Presentation: https://learning.arvo.org/diweb/catalog/item?id=5254050

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2769091&resultClick=1

    Suprachoroidal Delivery

    Title: Suprachoroidal Delivery with the SCS Microinjector™: Characterization of Operational Forces

    Authors: Nathan Fisher; Cherry Wan

    Conclusions: Forces to operate the SCS Microinjector using a variety of injectates are far below the international standard recommendations for low-volume hypodermic syringe operation. This may improve the usability of the SCS Microinjector by minimizing resistance forces inherent to the device, therefore allowing the user more accurate tactile feedback with loss of resistance when the suprachoroidal space is reached.

    Presentation: https://learning.arvo.org/diweb/catalog/launch/media/eid/5256365

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2766412&resultClick=1

    Title Retrospective Correlation Analysis of Suprachoroidal Injection Experience and Refraction

    Authors: Cherry Wan; Barry Kapik; Milan Shah; Christopher R Henry; Charles Clifton Wykoff; Mark Barakat

    Conclusions: While these analyses with a 900 µm needle compared to a 1100 µm needle are retrospective with a relatively small sample size, refraction appeared to have little correlation with the needle length used for suprachoroidal injections. This is supported by the literature that scleral thinning with myopia is more prominent along the anterior-posterior axis than around the circumference near the pars plana, where suprachoroidal injections are administered. Taken together, this indicates that suprachoroidal injections with the SCS Microinjector have the potential to reliably and repeatably deliver drugs for chorio-retinal diseases among a wide span of refractive values.

    Presentation: https://learning.arvo.org/diweb/catalog/launch/media/eid/5237367

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2769773&resultClick=1

    Title: Post hoc Analysis of Clinical Suprachoroidal Injection Experience Across Indications

    Authors: Mark Barakat; Cherry Wan; Barry Kapik

    Conclusions: To date, this is the largest aggregate dataset of suprachoroidal clinical injections with mounting evidence pointing to the reliability and consistency of the procedure. Despite the retrospective nature of the analyses, the results demonstrated the robustness of the suprachoroidal injection regardless of indications. The two needle length options successfully accommodate for anatomical variations across patients.

    Presentation: https://learning.arvo.org/diweb/catalog/launch/media/eid/5252042

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2769429&resultClick=1

    Macular Edema

    Title: Best Corrected Visual Acuity and Central Subfield Thickness in Macular Edema Due to Retinal Vein Occlusion, Diabetic Retinopathy and Noninfectious Uveitis

    Authors: Dilraj Grewal; Thomas A Ciulla; Barry Kapik

    Conclusions: In this cohort of over 1000 eyes, there were moderate relationships between BCVA and central subfield thickness (CST) in patients with ME due to RVO, diabetic macular edema (DME) and noninfectious uveitis at baseline and these were similar across disease states. There were also moderate relationships between BCVA and CST across these disease states with respect to change from baseline to 6 months. These correlations provide context around the use of CST in clinical decision making and visual recovery.

    Presentation: https://learning.arvo.org/diweb/catalog/item?id=5255154

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2767953&resultClick=1

    Title: Results from the Phase 3 PEACTHREE Clinical Trial: Efficacy of CLS-TA in Patients Not Taking Systemic Therapy, a Post-Hoc Analysis

    Authors: Christopher R Henry; Thomas Ciulla; Colette Hall

    Conclusions : These post hoc results corroborate the prespecified study analyses in the PEACHTREE trial. With respect to BCVA and CST, a clinically meaningful relative benefit of CLS-TA over control was noted in patients on systemic immunosuppression as well as those not on other systemic therapies.

    Presentation: https://learning.arvo.org/diweb/catalog/launch/media/eid/5229294   

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2769192&resultClick=1

    Title: Area of Disorganization of the Retinal Inner Layers (DRIL) as a Quantitative Biomarker in Eyes with Diabetic Macular Edema 

    Authors: Swetha Bindu Velaga; Muneeswar Gupta Nittala; Jyotsna Maram; Thomas A Ciulla; Michael S Ip; Srinivas Sadda

    Conclusions : The extent of DRIL appears to decrease following treatment of DME. Area of DRIL correlates better with visual function than the linear extent of DRIL, and may be a useful quantitative biomarker in future studies of diabetic macular edema.

    Abstract: https://iovs.arvojournals.org/article.aspx?articleid=2768726&resultClick=1

    Copies of these presentations will also be available on Clearside's website under the Publications & Presentations page here: https://www.clearsidebio.com/publications.htm.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade by acting at a different level of the angiogenesis cascade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies and may benefit patients who sub-optimally respond to current anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and outside investigators showed pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

    About Clearside's Suprachoroidal Space (SCS) Injection Platform

    Clearside's patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company's unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and the SCS Microinjector and the timeline for submitting the IND for CLS-AX. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, Clearside's Quarterly Report on Form 10-Q filed with the SEC on May 8, 2020 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  25. ALPHARETTA, Ga., May 08, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the first quarter ended March 31, 2020.

    "Our team remains focused on progressing our programs as we navigate the evolving business and regulatory environment," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "We are committed to advancing our first product candidate, XIPERE™, to the U.S. regulatory finish line as quickly as possible to maximize its commercial potential. Our Investigational New Drug application remains on track…

    ALPHARETTA, Ga., May 08, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the first quarter ended March 31, 2020.

    "Our team remains focused on progressing our programs as we navigate the evolving business and regulatory environment," said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. "We are committed to advancing our first product candidate, XIPERE™, to the U.S. regulatory finish line as quickly as possible to maximize its commercial potential. Our Investigational New Drug application remains on track for submission in mid-2020 for CLS-AX (axitinib injectable suspension) in wet age-related macular degeneration, which would potentially enable us to initiate a Phase 1/2a clinical trial before the end of this year. Additionally, we continue to support our clinical development partners in gene therapy and ocular cancer as they move their programs forward using our SCS Microinjector®."

    Key Highlights

    • Clearside and Bausch Health Companies Inc. and its leading global eye health business, Bausch + Lomb, amended their licensing agreement for the commercialization and development of XIPERE in the U.S. and Canada. Clearside granted Bausch + Lomb an exclusive option for the right to commercialize and develop XIPERE in (i) Europe and the United Kingdom, (ii) Australia and New Zealand, and/or (iii) South America and Mexico; and Bausch + Lomb extended the time allowed for Clearside to obtain regulatory approval for XIPERE in the U.S.   
    • NDA resubmission timeline for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension) is currently targeted for the fourth quarter of 2020 based on recent manufacturing updates.
    • Clearside received an upfront payment of $4.0 million from Arctic Vision pursuant to a license agreement for the commercialization and development of XIPERE in China, Hong Kong, Macau, Taiwan and South Korea.
    • Experienced research and development executive, Nancy J. Hutson, Ph.D., was appointed to Clearside's Board of Directors.
    • Clearside established a Scientific Advisory Board with highly experienced retinal physicians who will provide input on program and clinical development.
    • Multiple presentations featuring Clearside's suprachoroidal injection platform in a range of indications, including wet AMD, uveitis, diabetic macular edema and ocular gene therapy, were highlighted at global conferences, including the Annual Meeting of the Macula Society, the Annual Angiogenesis Meeting, and the Annual American Uveitis Society Winter Symposium.
    • Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, published results from the Phase 3 clinical trial of XIPERE (the PEACHTREE trial).

    First Quarter 2020 Financial Results

    Clearside's license revenue for the first quarter of 2020 was $4.1 million, compared to $45,000 for the first quarter of 2019. The $4.0 million increase was related to the receipt of the upfront payment from Arctic Vision.

    Research and development expenses for the first quarter of 2020 were $3.8 million, compared to $11.0 million for the first quarter of 2019. The $7.2 million decrease was primarily attributable to reduced expenses from two closed late-stage clinical trials.

    General and administrative expenses for the first quarter of 2020 were $3.1 million, compared to $4.4 million for the first quarter of 2019. The $1.3 million decrease was primarily attributable to lower marketing and employee-related expenses due to Clearside's out-licensing of the commercialization of XIPERE.

    Net loss for the first quarter of 2020 was $2.9 million, or $0.07 per share of common stock, compared to a net loss of $15.4 million, or $0.45 per share of common stock, for the first quarter of 2019. The decrease in net loss was primarily attributable to lower research and development expenses in 2020. 

    As of March 31, 2020, Clearside's cash and cash equivalents totaled $20.9 million. Based on Clearside's current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the second quarter of 2021.

    Clearside will not be hosting a conference call in conjunction with this release. The Company conducted a corporate update call on April 28, 2020, which is accessible on the Clearside website under the Investors section: Events and Presentations.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the timelines for resubmitting the NDA for XIPERE and submitting the IND for CLS-AX, as well as Clearside's ability to fund its operations into the second quarter of 2021, including the receipt of potential milestone payments. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    -Financial Tables Follow-


    CLEARSIDE BIOMEDICAL, INC.
    Selected Financial Data
    (in thousands, except share and per share data)
    (unaudited)

    Statements of Operations Data   Three Months Ended
    March 31,
     
        2020     2019  
    License and other revenue   $ 4,097     $ 45  
    Operating expenses:                
    Research and development     3,811       10,967  
    General and administrative     3,122       4,384  
    Total operating expenses     6,933       15,351  
    Loss from operations     (2,836 )     (15,306 )
    Other expense     (75 )     (98 )
    Net loss   $ (2,911 )   $ (15,404 )
    Net loss per share of common stock — basic and diluted   $ (0.07 )   $ (0.45 )
    Weighted average shares outstanding — basic and diluted     44,753,510       34,144,209  


    Balance Sheet Data March 31,     December 31,  
      2020     2019  
                   
    Cash and cash equivalents $ 20,930     $ 22,595  
    Restricted cash   360       360  
    Total assets   25,043       26,776  
    Deferred revenue   5,100       5,000  
    Debt (including current portion)   5,183       5,152  
    Total liabilities   14,603       15,619  
    Total stockholders' equity   10,440       11,157  

    Source: Clearside Biomedical, Inc. 

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  26. - Management to Host Webcast and Conference Call Today at 8:30 A.M. ET -

    ALPHARETTA, Ga., April 28, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today an update to the XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) New Drug Application (NDA) resubmission timeline and to its commercialization and development partnership with Bausch Health Companies Inc. ("Bausch Health") and Bausch + Lomb, its leading global eye health business.

    As previously disclosed, the contract manufacturing organization (CMO) for XIPERE has been completing…

    - Management to Host Webcast and Conference Call Today at 8:30 A.M. ET -

    ALPHARETTA, Ga., April 28, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today an update to the XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) New Drug Application (NDA) resubmission timeline and to its commercialization and development partnership with Bausch Health Companies Inc. ("Bausch Health") and Bausch + Lomb, its leading global eye health business.

    As previously disclosed, the contract manufacturing organization (CMO) for XIPERE has been completing certain requalification activities within its facility. While these manufacturing activities are not specifically related to XIPERE, the CMO has advised Clearside that they continue to impact the timing of its production. Although extensive progress has been made, the CMO needs to resolve a final step affecting the proper functioning of its filling line equipment in order to produce the required stability batches to generate the data necessary for the XIPERE NDA resubmission. As a result, and due in part to COVID-19 related challenges that have impacted work schedules, the CMO has informed Clearside that there will be a delay in completing the necessary corrective action. Based on this current information, Clearside now expects to resubmit the XIPERE NDA in the fourth quarter of 2020.

    In conjunction with this update, Clearside and Bausch Health have amended and revised their partnership for XIPERE. Bausch + Lomb acquired an exclusive license in October 2019 for the commercialization and development of XIPERE in the United States and Canada. Bausch + Lomb has now been granted exclusive options for the right to commercialize and develop XIPERE in (i) Europe and the United Kingdom, (ii) Australia and New Zealand, and (iii) South America and Mexico. In the amended agreement, Bausch + Lomb has extended the time allowed for Clearside to obtain XIPERE approval in the United States.

    "We remain firmly committed to receiving approval from the U.S. Food and Drug Administration for XIPERE as a potential treatment option for patients suffering from macular edema associated with uveitis," said George Lasezkay, Pharm.D., J.D., Clearside's President and Chief Executive Officer. "We have been working collaboratively with Bausch Health throughout this process and they have proven to be the ideal partner. We are pleased that their continued support of XIPERE and their interest in our suprachoroidal space (SCS®) injection platform has resulted in an opportunity to expand our relationship to maximize the commercial potential for XIPERE in additional important territories around the world."

    "Our other pipeline programs and external collaborations are not impacted by this timing, as there are separate CMOs for the SCS Microinjector®, CLS-AX (axitinib injectable suspension), and other compounds to be used in various clinical trials by our partners. We remain on track to submit an Investigational New Drug (IND) application in mid-2020 for CLS-AX in wet age-related macular degeneration, which would potentially enable us to initiate a Phase 1/2a clinical trial before the end of this year. We also expect a number of IND submissions in 2020 from our clinical development partners in gene therapy and ocular cancer utilizing our SCS Microinjector," concluded Dr. Lasezkay.

    As of March 31, 2020, Clearside's cash and cash equivalents totaled $20.9 million. Based on Clearside's current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the second quarter of 2021. Detailed financial results for the quarter will be reported via a press release on May 8, 2020.

    Management will host a webcast and conference call today at 8:30 a.m. Eastern Time to discuss this announcement and provide an update on the Company's clinical development pipeline.  The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 5612638.

    About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)

    XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and an exclusive option for Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health's affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector® targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the timelines for resubmitting the NDA for XIPERE and submitting the IND for CLS-AX, as well as submissions of INDs by Clearside's partners. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  27. ALPHARETTA, Ga., April 09, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today the formation of a Scientific Advisory Board comprised of world-renowned retinal physicians to advise on the Company's research and development programs. 

    "Over the past year, we have been building awareness around the potential benefits of targeting treatment in the suprachoroidal space and working closely with retinal specialists to present data on this novel approach. These efforts have led to the formation of a group of leading retinal physicians who can provide real-world…

    ALPHARETTA, Ga., April 09, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today the formation of a Scientific Advisory Board comprised of world-renowned retinal physicians to advise on the Company's research and development programs. 

    "Over the past year, we have been building awareness around the potential benefits of targeting treatment in the suprachoroidal space and working closely with retinal specialists to present data on this novel approach. These efforts have led to the formation of a group of leading retinal physicians who can provide real-world insights and validate the scientific rationale for our expanding pipeline programs. We are honored and grateful that Drs. Boyer, Brown, Holekamp, Kaiser and Regillo have joined our newly formed Scientific Advisory Board," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer of Clearside. "These physicians have collectively published at least a thousand scientific papers and are recognized thought leaders in the field of ophthalmology. We look forward to their guidance as we expand our research and clinical development strategy."

    "Clearside's novel technology platform delivering proprietary pharmacologic agents to the suprachoroidal space may offer innovative new treatment options for our patients.  My advisory board colleagues and I look forward to working with the Clearside team as they advance their research and development programs and explore new therapeutic targets," added Peter K. Kaiser, M.D.

    Members of the Clearside Scientific Advisory Board:

    David S. Boyer, M.D. is a clinician, surgeon, and educator at the Retina-Vitreous Associates Medical Group in Southern California. He is board certified in ophthalmology and has completed formal sub-specialty training in medical and surgical diseases of the retina, vitreous, and macula. Dr. Boyer is currently a leading investigator for various national clinical trials on retinal diseases and serves as an advisor for multiple research, educational and charitable institutions. He received his medical degree from the Chicago Medical School, finished his residency at the Los Angeles County - USC County Medical Center, and completed his retinal surgery fellowship at the Wills Eye Hospital in Philadelphia.

    David M. Brown, M.D. is a medical and surgical retinal specialist and clinical trial specialist at Retina Consultants Houston. He has pioneered research in the areas of age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion. He is the director of the Greater Houston Retina Research Center, a clinical professor of Ophthalmology at Baylor College of Medicine, the Vice-Chair for research at the Blanton Eye Institute at Houston Methodist Hospital, and serves as the consultant retinal specialist for NASA. Dr. Brown received his medical degree from Baylor College of Medicine, and completed ophthalmology and retina training at the University of Iowa.

    Nancy M. Holekamp, M.D. is a professor of Clinical Ophthalmology and Visual Sciences at the Washington University School of Medicine, and director of Retina Services at the Pepose Vision Institute, both in St. Louis, Missouri. She has been actively involved in clinical trials dealing with AMD, retinal vascular occlusion, and diabetic retinopathy. Dr. Holekamp serves as a reviewer for multiple major ophthalmology journals, and served on the American Academy of Ophthalmology Ethics Committee for six years. She received her medical degree from the Johns Hopkins School of Medicine, completed an internship in internal medicine and a residency in ophthalmology at the Washington University School of Medicine, and completed her fellowship training in vitreoretinal surgery with the Retina Consultants in St. Louis.

    Peter K. Kaiser, M.D. is the Chaney Family Endowed Chair for Ophthalmology Research and a Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine. As an NIH grant funded investigator, Dr. Kaiser leads a team involved in the evaluation of vascular biology in AMD and diabetic retinopathy, and is actively involved in numerous clinical trials. He is Editor-in-Chief of Retinal Physician, Associate Editor of International Ophthalmology Clinics, and serves on the editorial boards of several other publications. Dr. Kaiser received his medical degree from Harvard Medical School, completed his internal medicine internship at Massachusetts General Hospital, an ophthalmology residency at the Massachusetts Eye and Ear Infirmary, and a vitreoretinal fellowship at Bascom Palmer Eye Institute.

    Carl D. Regillo, M.D., F.A.C.S is the Director of the Retina Service of Wills Eye Hospital, and Professor of Ophthalmology at Thomas Jefferson University School of Medicine. He is the principal investigator of numerous international clinical trials investigating new forms of treatment for macular degeneration, diabetic retinopathy, and other retinal conditions.  Dr. Regillo is a fellow of the American College of Surgeons and has served on the scientific editorial board for several ophthalmic publications. He received his medical degree from Harvard Medical School and performed his internship in internal medicine at Harvard's Brigham and Women's Hospital in Boston, and both his ophthalmology residency and vitreoretinal fellowship at Wills Eye Hospital in Philadelphia. After training, he was commissioned as a Major in the United States Air Force and served four years as a vitreoretinal surgeon at the San Diego Naval Medical Center.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential of the suprachoroidal injection platform and the advancement of Clearside's research and development programs. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission ("SEC") on March 13, 2020, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  28. ALPHARETTA, Ga., April 08, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer and Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer will present a company overview at the Needham Virtual Healthcare Conference on April 15, 2020 at 12:00 p.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About

    ALPHARETTA, Ga., April 08, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer and Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer will present a company overview at the Needham Virtual Healthcare Conference on April 15, 2020 at 12:00 p.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:



    Jenny Kobin

    Remy Bernarda



    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  29. - IND Submission for CLS-AX (axitinib injectable suspension) On Track for Mid-2020 -
    - Greater China Licensing Partnership and Updated NDA Resubmission Timeline for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) -
    - Partners Expected to Initiate Clinical Testing in 2020 for Treatment of Wet AMD, Diabetic Retinopathy and Ocular Cancer Using SCS Microinjector -
    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., March 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for…

    - IND Submission for CLS-AX (axitinib injectable suspension) On Track for Mid-2020 -
    - Greater China Licensing Partnership and Updated NDA Resubmission Timeline for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) -
    - Partners Expected to Initiate Clinical Testing in 2020 for Treatment of Wet AMD, Diabetic Retinopathy and Ocular Cancer Using SCS Microinjector -
    - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

    ALPHARETTA, Ga., March 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update.

    "The momentum for Clearside is building as we increase awareness of our suprachoroidal space injection platform, develop our internal pipeline and work with our partners to advance multiple clinical programs," said George Lasezkay, Pharm.D., J.D., Clearside's President and Chief Executive Officer. "We have been encouraged by the medical community's interest in our preclinical data on CLS-AX (axitinib injectable suspension), which we believe could support the potential for long-acting pan-VEGF inhibition in wet age-related macular degeneration. We expect to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CLS-AX in mid-2020, which would potentially enable us to initiate a Phase 1/2a clinical trial before the end of this year. Our pipeline is also growing as our partners in gene therapy and ocular cancer are moving to initiate clinical testing of their compounds using our proprietary SCS Microinjector™. Based on our partners' plans, we expect several IND submissions and the initiation of multiple clinical trials in 2020."

    Dr. Lasezkay continued, "As we continue to progress our XIPERE program and partnerships, we are working together with Bausch + Lomb and our commercial manufacturer to ensure the most thorough and highest quality New Drug Application (NDA) resubmission. We currently expect to resubmit our NDA for XIPERE by the end of August 2020 and believe the FDA will review the NDA within six months of receipt of the resubmission. We also signed a new development and commercialization partnership with Arctic Vision that expands the global reach of XIPERE to Greater China and South Korea. This collaboration adds $4.0 million in an upfront payment to our balance sheet with the possibility of additional revenue through future milestone payments up to $31.5 million and royalties on product sales."

    Key Highlights and Upcoming Milestones

    • License agreement with upfront and milestone payments and royalties on product sales from Arctic Vision for the commercialization and development of XIPERE in Greater China and South Korea.
    • George Lasezkay, Pharm.D., J.D. was appointed President and Chief Executive Officer, transitioning from the Interim CEO position.
    • Adeno-associated virus (AAV) gene therapy partner, REGENXBIO, plans to initiate its Phase 2 clinical trial for suprachoroidal delivery of RGX-314 using the SCS Microinjector for treatment of wet age-related macular degeneration (wet AMD) in the first half of 2020, with interim data from the first cohort expected by the end of 2020.
    • REGENXBIO expects to submit an IND application for a Phase 2 trial for treatment of diabetic retinopathy in the first half of 2020 using the SCS Microinjector to deliver RGX-314 to the suprachoroidal space. The trial is expected to begin in the second half of 2020 and enrollment of the first cohort is expected to be complete by the end of 2020, with interim data expected in 2021.
    • Ocular oncology partner, Aura Biosciences, expects to initiate clinical testing during the second half of 2020 using suprachoroidal delivery for AU-011 for the potential treatment of certain ocular cancers, including choroidal melanoma.
    • Preclinical data on Clearside's lead development asset, CLS-AX was presented at the 43rd Annual Meeting of The Macula Society.
    • Multiple oral presentations featuring Clearside's suprachoroidal injection platform in a range of indications, including wet AMD, uveitis, diabetic macular edema and ocular gene therapy, were highlighted at global conferences, including the Annual Meeting of The Macula Society, the Annual Angiogenesis Meeting, the Annual American Uveitis Society Winter Symposium and the American Academy of Ophthalmology Annual Meeting.
    • Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, published results from the Phase 3 clinical trial of XIPERE (the PEACHTREE trial).

    Fourth Quarter 2019 Financial Results

    Clearside's license revenue for the fourth quarter of 2019 was $1.9 million, compared to $30,000 for the fourth quarter of 2018. The $1.9 million increase was associated with payments from partner licensing agreements.

    Research and development expenses for the fourth quarter of 2019 were $1.3 million, compared to $17.5 million for the fourth quarter of 2018. The $16.2 million decrease was primarily attributable to reduced expenses from two closed late-stage clinical trials and  subsequent vendor credits of $2.0 million upon reconciliation of final trial costs.

    General and administrative expenses for the fourth quarter of 2019 were $3.7 million, compared to $4.2 million for the fourth quarter of 2018. The $0.5 million decrease was primarily attributable to lower marketing and employee-related expenses due to Clearside's out-licensing of the commercialization of XIPERE.

    Net loss for the fourth quarter of 2019 was $3.1 million, or $0.07 per share of common stock, compared to a net loss of $21.6 million, or $0.68 per share of common stock, for the fourth quarter of 2018. The decrease in net loss was primarily attributable to lower research and development expenses in 2019. 

    Full Year 2019 Financial Results

    Clearside's license and collaboration revenue for the year ended December 31, 2019 was $2.2 million, compared to $30,000 for the year ended December 31, 2018. The $2.1 million increase was associated with payments from partner licensing agreements.

    Research and development expenses for the year ended December 31, 2019 were $15.7 million, compared to $68.3 million for the year ended December 31, 2018. The $52.6 million decrease was primarily attributable to reduced expenses from two closed late-stage clinical trials.

    General and administrative expenses were $16.8 million for the year ended December 31, 2019, compared to $14.7 million for the year ended December 31, 2018. The $2.1 million increase was primarily attributable to increased employee-related costs, including accrued expenses related to the resignation of Clearside's former CEO.

    Net loss for the year ended December 31, 2019 was $30.8 million, or $0.81 per share of common stock, compared to a net loss of $82.8 million, or $2.69 per share of common stock, for the year ended December 31, 2018. The decrease in net loss was primarily attributable to lower research and development expenses in 2019.

    Cash and cash equivalents totaled $22.6 million as of December 31, 2019, which included partner licensing revenue and private placement funding received in the fourth quarter of 2019. The Company expects to have sufficient resources to fund planned operations into the first quarter of 2021.

    Conference Call & Webcast Details

    Clearside's management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 2462408. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding opportunities for expanding Clearside's internal pipeline, the potential benefits of XIPERE and the SCS injection platform, the potential receipt of milestone payments, the timing for resubmitting the XIPERE NDA and the anticipated outcome of interactions with the FDA and the development and potential benefits of CLS-AX, including the timing for the IND submission for CLS-AX. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 8, 2019 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    -Financial Tables Follow-



    CLEARSIDE BIOMEDICAL, INC.
    Selected Financial Data
    (in thousands, except share and per share data)
    (unaudited)

    Statements of Operations Data   Three Months Ended
    December 31,
        Year Ended
    December 31,
     
        2019     2018     2019     2018  
    License revenue   $ 1,942     $ 30     $ 2,173     $ 30  
    Operating expenses:                                
    Research and development     1,305       17,486       15,658       68,291  
    General and administrative     3,650       4,176       16,819       14,684  
    Total operating expenses     4,955       21,662       32,477       82,975  
    Loss from operations     (3,013 )     (21,632 )     (30,304 )     (82,945 )
    Other (expense) income, net     (83 )     (6 )     (466 )     127  
    Net loss   $ (3,096 )   $ (21,638 )   $ (30,770 )   $ (82,818 )
    Net loss per share of common stock — basic and diluted   $ (0.07 )   $ (0.68 )   $ (0.81 )   $ (2.69 )
    Weighted average shares outstanding — basic and diluted     42,394,959       32,041,305       38,170,830       30,733,600  


    Balance Sheet Data December 31,     December 31,  
      2019     2018  
                   
    Cash, cash equivalents and short-term investments $ 22,595     $ 40,878  
    Restricted cash   360       360  
    Total assets   26,776       44,120  
    Deferred revenue   5,000       ̶   
                   
    Long-term debt (including current portion)   5,152       9,975  
    Total liabilities   15,619       20,500  
    Total stockholders' equity   11,157       23,620  
                   

    Source: Clearside Biomedical, Inc.

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  30. ALPHARETTA, Ga., March 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., has been appointed President and Chief Executive Officer. He will continue to serve on the Board of Directors. This appointment was effective March 1, 2020.

    William Humphries, Chairman of the Clearside Board of Directors, said, "Clearside has made meaningful progress during George's tenure as Interim CEO. We are very pleased that he has agreed to take the position of President and CEO, given his proven ability to focus and lead the organization…

    ALPHARETTA, Ga., March 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., has been appointed President and Chief Executive Officer. He will continue to serve on the Board of Directors. This appointment was effective March 1, 2020.

    William Humphries, Chairman of the Clearside Board of Directors, said, "Clearside has made meaningful progress during George's tenure as Interim CEO. We are very pleased that he has agreed to take the position of President and CEO, given his proven ability to focus and lead the organization in a complex environment. In less than one year, we have concluded preclinical studies to advance CLS-AX (axitinib injectable suspension) into the clinic and have added multiple partnerships for our suprachoroidal space injection platform, including two key licensing agreements for the commercialization of our late stage asset, XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension). These accomplishments provide strong momentum for Clearside as we build on the value of our proprietary suprachoroidal injection platform."

    "I am excited about having the opportunity to continue working closely with the Clearside team and I am grateful to the Board for their confidence and support," said George Lasezkay, Pharm.D., J.D., President and CEO, Clearside Biomedical. "We are well underway in executing our two-pronged strategy of building an internal research and development pipeline in areas such as novel small molecules and gene therapy, as well as creating external collaborations with other companies to enable them to deliver therapies in a targeted, repeatable, non-surgical manner via the suprachoroidal space. I look forward to continued interactions with the medical and investor communities."

    About George Lasezkay, Pharm.D., J.D.

    Dr. Lasezkay has an accomplished history of success in the life sciences industry. For the past 15 years, he has served as an independent director on the boards of a number of domestic and foreign emerging biopharmaceutical companies, including serving as a director of Clearside since August 2017. Beginning in April 2019, Dr. Lasezkay served as the Company's Interim CEO.

    Previously, Dr. Lasezkay served as Executive Vice President and General Counsel at Acucela Inc., a development stage company that specializes in identifying and developing novel ophthalmic therapeutics. For the 10 years prior to joining Acucela, he was President of Horizon Pharma Group, a private life sciences consultancy practice. Prior to Horizon, Dr. Lasezkay was Corporate Vice President for Corporate Development at Allergan, Inc., the global pharmaceutical and medical aesthetics company. His 13 years of progressive experience at Allergan involved a number of executive leadership positions, including being a member of the company's Executive Committee, Assistant General Counsel for Commercial Affairs, and General Counsel for the Asia-Pacific Region.

    Dr. Lasezkay has played a critical role in developing corporate strategy and has been responsible for a wide variety of licensing, research and development collaboration and acquisition transactions involving new technologies, products and companies. He also has a multi-disciplinary background in private firm and in-house legal practice, hospital pharmacy practice, clinical pharmacokinetics consultation and clinical drug research.

    Dr. Lasezkay earned his B.S. Pharmacy and Doctor of Pharmacy degrees from the State University of New York at Buffalo School of Pharmacy, and a J.D. degree from the University of Southern California Gould School of Law.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential of the suprachoroidal injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 6, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  31. – Arctic Vision to Lead Expansion of Novel Approach to Treating Macular Edema Associated with Uveitis in Asia –
    – Clearside Eligible to Receive Upfront and Milestone Payments and Royalties on Product Sales –
    – Increasing Global Awareness of Innovative Suprachoroidal Injection Platform –

    ALPHARETTA, Ga. and SHANGHAI, China, March 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Arctic Vision, a company focused on developing and commercializing innovative ophthalmology therapies in China and Asia, has acquired an exclusive license for the commercialization…

    – Arctic Vision to Lead Expansion of Novel Approach to Treating Macular Edema Associated with Uveitis in Asia –
    – Clearside Eligible to Receive Upfront and Milestone Payments and Royalties on Product Sales –
    – Increasing Global Awareness of Innovative Suprachoroidal Injection Platform –

    ALPHARETTA, Ga. and SHANGHAI, China, March 11, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Arctic Vision, a company focused on developing and commercializing innovative ophthalmology therapies in China and Asia, has acquired an exclusive license for the commercialization and development of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.

    XIPERE is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration via Clearside's proprietary SCS Microinjector™ that is being investigated as a targeted treatment of macular edema associated with uveitis.

    "This licensing agreement further enables Clearside to expand the commercial opportunity for XIPERE in an attractive geographic market," said George Lasezkay, Pharm.D., J.D., President and CEO, Clearside Biomedical. "We look forward to collaborating with Arctic Vision's seasoned team of ophthalmic industry veterans who have substantial global experience at leading eye care companies, including Allergan, and expertise in launching eye care products in China, such as OZURDEX® (dexamethasone intravitreal implant). With strong resources and backing by top-tier global biotech venture capital investor, Pivotal bioVenture Partners, we believe Arctic Vision will be an effective strategic partner in helping to drive the expansion of XIPERE, if approved, in this important market."

    "We are excited to enter into this partnership with Clearside and we look forward to working together to bring this novel therapy to patients and healthcare providers in Greater China and South Korea," said Eddy (Hoi Ti) Wu, Ph.D., Founder and CEO, Arctic Vision. "Due to the lack of satisfactory treatment with optimal efficacy and safety in our region, patients living with uveitis are in great need of an innovative approach. By potentially bringing meaningful benefit to these patients, XIPERE is an excellent addition to our growing portfolio of breakthrough treatments as we strive to lead the China ophthalmology market."

    Under the terms of the agreement, Clearside may receive up to a total of $35.5 million in development and sales milestones. This amount includes a $4.0 million upfront payment plus additional milestone payments for the achievement of specified events prior to and including receipt of approval of XIPERE in the United States. Clearside also will be entitled to receive tiered royalties of 10% to 12% based on annual net sales of XIPERE in Greater China and South Korea. Arctic Vision may pursue development and commercialization of XIPERE for additional ophthalmic indications in Greater China and South Korea, with consent from Clearside.

    About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)

    XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has the exclusive license for the commercialization and development of XIPERE in the United States and Canada (through a license agreement between Clearside and Bausch Health's affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS®) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    About Arctic Vision

    Arctic Vision is a leading specialty ophthalmology company in China with a portfolio of breakthrough technologies. The Company is led by an elite team of ophthalmic industry veterans with substantial and successful China and global experiences in R&D and commercialization of eye care products. Arctic Vision has top-tier biotech venture capital investors with a broad network in both China and the U.S./European ophthalmic markets, in-depth knowledge and an unprecedented track record in company incubation in China. For more information, please visit www.arcticvision.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding XIPERE's commercial potential and Arctic Vision's ability to successfully launch XIPERE in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 6, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  32. ALPHARETTA, Ga., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its fourth quarter and full year 2019 financial results will be reported on Wednesday, March 11, 2020 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213…

    ALPHARETTA, Ga., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that its fourth quarter and full year 2019 financial results will be reported on Wednesday, March 11, 2020 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

    The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 2462408. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  33. ALPHARETTA, Ga., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the Company will present at two upcoming investor conferences in March 2020:

    Cowen 40th Annual Health Care Conference
    Company Presentation: Wednesday, March 4, 2020 at 8:00 am ET
    Boston, MA

    32nd Annual ROTH Conference
    Panel Presentation: Tuesday, March 17, 2020 at 12:00 pm PT
    Dana Point, CA

    A link to the live and archived webcasts may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcasts will be available for…

    ALPHARETTA, Ga., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the Company will present at two upcoming investor conferences in March 2020:

    Cowen 40th Annual Health Care Conference
    Company Presentation: Wednesday, March 4, 2020 at 8:00 am ET
    Boston, MA

    32nd Annual ROTH Conference
    Panel Presentation: Tuesday, March 17, 2020 at 12:00 pm PT
    Dana Point, CA

    A link to the live and archived webcasts may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcasts will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  34. – Preclinical data presented on lead development asset, CLS-AX (axitinib injectable suspension) –

    – Suprachoroidal injection platform featured in multiple indications including wet AMD, uveitis, diabetic macular edema, and ocular gene therapy –

    ALPHARETTA, Ga., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space were given this month at the 17th Annual Angiogenesis Meeting and 43rd Annual Macula Society Meeting.

    "February…

    – Preclinical data presented on lead development asset, CLS-AX (axitinib injectable suspension) –

    – Suprachoroidal injection platform featured in multiple indications including wet AMD, uveitis, diabetic macular edema, and ocular gene therapy –

    ALPHARETTA, Ga., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space were given this month at the 17th Annual Angiogenesis Meeting and 43rd Annual Macula Society Meeting.

    "February was an extremely productive month for Clearside as our pipeline continues to gain exposure within the physician community, resulting in multiple oral presentations on our programs," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer. "Importantly, preclinical data was discussed on axitinib for suprachoroidal injection (CLS-AX) supporting the potential for long-acting pan-VEGF inhibition in wet AMD. This positive data provides the rationale to advance this asset that could ultimately lead to improved, long-term, real-world visual outcomes and reduced treatment burden for patients. We expect to submit an Investigational New Drug (IND) application for CLS-AX in mid-2020 and we look forward to initiating Phase 1/2 clinical trial."

    Dr. Ciulla concluded, "Numerous presentations were also given on our clinical trials results for XIPERETM and on the broad applicability of our suprachoroidal injection platform. Also featured was a discussion on the potential advantages of suprachoroidal injection of gene therapy. We believe that suprachoroidal injection can be an in-office procedure, with potential safety benefits for patients by avoiding the risks of sub-retinal administration. We are grateful to the numerous retinal specialists who dedicated their time at these medical meetings and support our efforts to potentially offer improved treatment options for their patients."

    CLS-AX (axitinib injectable suspension) & Suprachoroidal Injection

    Title:  Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
    Author: Shree K. Kurup, M.D., FACP, Director, Division of Vitreoretinal Diseases, Surgery and Ocular Immunology and Uveitis, University Hospitals
    Summary: Dr. Kurup presented the first public data for Clearside's lead investigational agent, CLS-AX (axitinib injectable suspension) for suprachoroidal injection. Suprachoroidal axitinib has the potential to address primary needs for neovascular AMD patients, as its durability may reduce treatment burden while maintaining vision. Its pan-VEGF inhibition in wet AMD has the potential to be more efficacious than current focused VEGF inhibition approaches.  Information from Dr. Kurup's literature review showed there is strong preclinical evidence on the potential efficacy of axitinib as a tyrosine kinase inhibitor (TKI). Specifically: (1) Anti-VEGF A upregulated VEGF-C and VEGF-D, (2) axitinib inhibited neovascularization in the cornea, retina, and choroid, and (3) axitinib had improved biocompatibility with ocular cells relative other TKIs. Suprachoroidal CLS-AX was tested in multiple animal models demonstrating high drug concentration in the retina and choroid-RPE/sclera and lower concentration in the vitreous, and reduction of fluorescein leakage and vessel growth versus control. Across all animal models, suprachoroidal CLS-AX was well tolerated with no signs of toxicity at the intended clinical dose, with sparing of the anterior chamber of the eye and systemic circulation. Overall, suprachoroidal CLS-AX could lead to reduced treatment burden on patients and improved, longer term visual outcomes.
       
    Title:  Update on Therapeutic Suprachoroidal Injection
    Author: Thomas A. Albini, M.D., Bascom Palmer Eye Institute; Professor of Clinical Ophthalmology, University of Miami Miller School of Medicine
    Summary: Dr. Albini's presentation reviewed the benefits and broad uses of suprachoroidal injection as it relates to Clearside's pipeline. His discussion focused on the key aspects and uses of this delivery mechanism: 1) small molecule suspension suprachoroidal delivery has shown durability and has been demonstrated with triamcinolone, a tyrosine kinase inhibitor (TKI), and a complement inhibitor; 2) suprachoroidal compartmentalization has potential for safety as demonstrated in the clinical trials with triamcinolone; and 3) the unique ocular distribution of suprachoroidal delivery creates a  potential path forward for other therapies including office-based gene therapy and choroidal diseases such as melanoma. Data from Clearside's clinical trials and information on the Company's recent partnerships were also referenced.

    XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) for Uveitis

    Title: Front-line Local Therapies for Uveitis: From Clinical Trials to Practice
    Author: Steven Yeh, M.D., Associate Professor, Emory Eye Center
    Summary:  In his presentation, Dr. Yeh discussed the complications of uveitis and current treatment options. He showed multiple Phase 3 studies that have demonstrated the benefits of local corticosteroids administered via novel drug delivery platforms for macular edema due to noninfectious uveitis.  Data from Clearside's PEACHTREE and MAGNOLIA clinical trials were highlighted as evidence of the potential effectiveness of suprachoroidal delivery. He also reviewed other agents in development and concluded that the field currently has a promising outlook for local delivery options for noninfectious uveitis.
       
    Title:  Intraocular Pressure Following Administration of Suprachoroidal Triamcinolone Acetonide Suspension (CLS-TA): Results from the Phase 3 PEACHTREE Clinical Trial for Uveitis
    Author: Michael A. Singer, M.D., Medical Center Ophthalmology Associates; Clinical Professor, Ophthalmology, University of Texas Health Science Center
    Summary: Dr. Singer presented preclinical and clinical data which  demonstrated that injection into the suprachoroidal space allows for targeted and compartmentalized delivery. Preclinical data showed that posterior tissues, including the sclera/choroid and outer retina contained higher concentration of triamcinolone (TA) when injected suprachoroidally compared to intravitreally. TA was also found in lower concentration in the aqueous humor and iris/ciliary body when delivered suprachoroidally compared to intravitreally. Dr. Singer presented clinical data from the PEACHTREE trial with a focus on intraocular pressure (IOP). With respect to elevated IOP-related adverse events (AEs), the rate was 11.5% in the CLS-TA treatment group (n=11/96) compared to 15.6% in the control group (n=10/64). The number of IOP events in the control group was due to the type of rescue medications delivered, at the discretion of the investigator. Rescue medications were required in 72% (n=46/64) of the patients in the control group and only 13% (n=13/96) in the CLS-TA group. Clinically relevant IOP endpoints were evaluated through week 24. IOP ≥ 30mmHg was observed in only 4.8% of CLS-TA treated eyes (n=4/83) that did not receive rescue medication compared to 10.9% of control eyes (n=5/46) that received rescue. Similarly, IOP lowering medications were used in fewer eyes treated only with CLS-TA (7.2%; n=6/83) compared to the control eyes receiving rescue treatment (13%; n=6/46). 

    Ocular Gene Therapy

    Title:  Suprachoroidal Delivery for Ocular Gene Therapy: Nonclinical Experiments Evaluating Non-Viral DNA Nanoparticles in Non-Human Primates (NHPs)
    Author: Mathew W. MacCumber, M.D., Ph.D., Illinois Retina Associates; Professor and Associate Chairman for Research. Department of Ophthalmology, Rush University Medical Center
    Summary: In his presentation, Dr. MacCumber provided the rationale for using suprachoroidal (SC) injection as a potentially safe, targeted and efficient delivery mechanism for gene therapy. He shared information on suprachoroidal delivery of viral vectors in preclinical models, including data from non-human primates showing that suprachoroidal RGX-314 (REGENXBIO) resulted in similar suppression of VEGF-induced vascular leakage as subretinal delivery. He reviewed the potential advantages of DNA Nanoparticles (DNPs), including efficacy in animal models, the ability to transfer large genes, and safety aspects, specifically that DNPs are non-immunogenic and offer the potential for repeat dosing. Dr. MacCumber shared the results of SC injection of Luciferase DNPs in non-human primates, which resulted in luciferase activity observed in the retina and choroid of all eyes that received an SC injection. SC injection of DNPs in non-human primates were generally well tolerated across groups with no significant abnormalities observed.

    Diabetic Macular Edema

    Title: Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Diabetic Macular Edema: A "Real World" Analysis in 28,456 Eyes
    Author:  Thomas A Ciulla, M.D., MBA, Clearside Chief Medical Officer
    Summary: This retrospective analysis was designed to assess visual acuity (VA) outcomes and anti-VEGF treatment intensity in patients with diabetic macular edema (DME). The analysis of 28,456 eyes was performed in treatment-naïve DME patients from 2013 to 2018, using a database of aggregated de-identified electronic medical records. The study found that although the introduction of anti-VEGF agents has led to notably improved outcomes for patients with DME, there are several practical limitations, including the need for frequent injections and incomplete response in some patients.  In clinical practice, DME patients undergo fewer anti-VEGF injections and exhibit worse visual outcomes compared to patients in randomized clinical trials. Consequently, "real world" DME treatment compliance can be poor. This analysis demonstrates a large unmet need for DME therapies that address treatment burden and incomplete response.
       
    Title: Analysis of OCT Biomarkers in the Randomized Phase 2 TYBEE Trial of Suprachoroidal CLS-TA Plus Aflibercept Compared with Aflibercept Monotherapy for DME
    Lead Author: Michael S. Ip, M.D., The Doheny Image Reading Center, Doheny Eye Institute, University of California – Los Angeles
    Summary: Dr. Ip and his team evaluated secondary results from Clearside's Phase 2, double-masked, 6-Month TYBEE clinical trial in patients with Diabetic Macular Edema (DME). The trial evaluated combination aflibercept and suprachoroidal CLS-TA treatment compared to aflibercept monotherapy at Week 24. The results from TYBEE demonstrated that fewer treatment visits were needed in the combination arm (2.8) compared to aflibercept monotherapy (4.7), suggesting the potential to address treatment burden. The trial also showed greater reduction of central subfield thickness (CST) with combination treatment (-226.5μm) versus monotherapy (-176.1μm). Analysis of additional anatomical outcomes when comparing the two treatments included disorganization of the retinal inner layers (DRIL) and choroidal vascularity index (CVI). In the trial, changes in DRIL were similar in both arms and DRIL could be a reasonable biomarker to evaluate in future DME clinical trials.

    These presentations will be available on Clearside's website in the Publications section under Programs: https://www.clearsidebio.com/publications.htm.

    About CLS-AX (axitinib injectable suspension)

    CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer, that achieves pan-VEGF blockade by acting at a different level of the angiogenesis cascade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies and may benefit patients who sub-optimally respond to current anti-VEGF therapies. Suprachoroidal injection of a proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. First, axitinib has intrinsic high potency and can achieve pan-VEGF inhibition through receptor blockade. Second, preclinical results from Clearside and outside investigators showed pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. Third, suprachoroidal administration of axitinib can potentially achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for wet AMD and expects to submit an IND application in mid-2020.

    About XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension)

    XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., has the exclusive license for the commercialization and development of XIPERE in the United States and Canada (through a license agreement between Clearside and Bausch Health's affiliate).

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding opportunities for expanding Clearside's internal pipeline, the potential benefits of XIPERE and the SCS injection platform, and the development and potential benefits of CLS-AX, including the timing for the IND submission for CLS-AX. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 6, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc. 

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  35. ALPHARETTA, Ga., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space will be given at the upcoming annual Angiogenesis and Macula Society meetings.

    Presentations at the 17th Annual Angiogenesis Meeting to be held February 8, 2020 in Miami, Florida:

    Title: Front-line Local Therapies for Uveitis: From Clinical Trials to Practice
    Lead Author: Steven Yeh, M.D., Associate Professor, Emory Eye Center
    Date/Time: Saturday, February

    ALPHARETTA, Ga., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space will be given at the upcoming annual Angiogenesis and Macula Society meetings.

    Presentations at the 17th Annual Angiogenesis Meeting to be held February 8, 2020 in Miami, Florida:

    Title: Front-line Local Therapies for Uveitis: From Clinical Trials to Practice
    Lead Author: Steven Yeh, M.D., Associate Professor, Emory Eye Center
    Date/Time: Saturday, February 8th, 5:24 p.m. ET


    Title: Update on Therapeutic Suprachoroidal Injection
    Lead Author:  Thomas A. Albini, M.D., Bascom Palmer Eye Institute; Professor of Clinical Ophthalmology, University of Miami Miller School of Medicine
    Date/Time: Saturday, February 8th, 5:32 p.m. ET

    Presentations at the 43rd Annual Macula Society Meeting to be held February 19-22, 2020 in San Diego, California:

    Title: Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Diabetic Macular Edema: A "Real World" Analysis in 28,456 Eyes
    Lead Author: Thomas A. Ciulla, M.D., Chief Medical Officer, Clearside Biomedical, Inc.
    Date/Time: Thursday, February 20th, 10:28 a.m. PT
    Session: Session VI – Diabetic Retinopathy I

                   

    Title: Intraocular Pressure Following Administration of Suprachoroidal Triamcinolone Acetonide Suspension (CLS-TA): Results from the Phase 3 PEACHTREE Clinical Trial for Uveitis
    Lead Author: Michael A. Singer, M.D., Medical Center Ophthalmology Associates; Clinical Professor, Ophthalmology, University of Texas Health Science Center
    Date/Time: Thursday, February 20th, 12:21 p.m. PT
    Session: VII – Retinal Vein Occlusion and Uveitis


    Title: Pre-Clinical Results to Clinical Trial Outcomes: Results Correlate in Suprachoroidal Delivery for Treatment of Macular Edema Associated with Uveitis
    Lead Author: Dennis M. Marcus, M.D., Southeast Retina Center
    Date/Time: Thursday, February 20th,  12:42 p.m. PT
    Session: VII – Retinal Vein Occlusion and Uveitis


    Title: Suprachoroidal CLS-AX (axitinib injectable suspension), as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
    Lead Author: Shree K. Kurup, M.D., FACP, Director, Division of Vitreoretinal Diseases, Surgery and Ocular Immunology and Uveitis, University Hospitals
    Date/Time:  Friday, February 21st, 11:53 a.m. PT     
    Session: XII – Neovascular AMD II


    Title: Suprachoroidal Delivery for Ocular Gene Therapy: Nonclinical Experiments Evaluating Non-Viral DNA Nanoparticles in Non-Human Primates (NHPs)
    Lead Author: Mathew W. MacCumber, M.D., Ph.D., Illinois Retina Associates; Professor and Associate Chairman for Research. Department of Ophthalmology, Rush University Medical Center
    Date/Time: Saturday, February 22nd, 9:03 a.m. PT
    Session: XIV – Genetics and Gene Therapy

                   

    Title: Disorganization of the Retinal Inner Layers (DRIL) as a Marker: Results of TYBEE Phase 2 in Diabetic Macular Edema
    Lead Author: Michael S. Ip, M.D., Doheny Eye Institute, David Geffen School of Medicine at University of California Los Angeles
    Date/Time: Saturday, February 22nd, 11:24 a.m. PT 
    Session #: XVI - Diabetic Retinopathy Imaging and Screen

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential benefits of CLS-AX and the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc. 

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  36. LAVAL, Quebec and ALPHARETTA, Ga., Jan. 28, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (TSX:BHC) ("Bausch Health") and Bausch + Lomb, its leading global eye health business, and Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the randomized, controlled, double-masked Phase 3 clinical trial (PEACHTREE study) of XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), an investigational therapy with a proposed indication of treatment of macular…

    LAVAL, Quebec and ALPHARETTA, Ga., Jan. 28, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (TSX:BHC) ("Bausch Health") and Bausch + Lomb, its leading global eye health business, and Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the randomized, controlled, double-masked Phase 3 clinical trial (PEACHTREE study) of XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), an investigational therapy with a proposed indication of treatment of macular edema associated with uveitis.1  

    "Macular edema is the leading cause of vision loss in patients with uveitis," said Steven Yeh, M.D., lead author and principal investigator for the PEACHTREE study, and M. Louise Simpson Associate professor of ophthalmology, Emory Eye Center. "The efficacy and safety data from the PEACHTREE Phase 3 trial showed that delivery of XIPERE via suprachoroidal administration, an alternative technique for delivering ocular therapies, may facilitate more targeted delivery of therapeutic agents to the retina and choroid. Targeted drug delivery via the suprachoroidal space may also limit corticosteroid exposure to the anterior segment with the potential to decrease adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, that can commonly arise from other local corticosteroid delivery techniques."

    The data demonstrated that patients with noninfectious uveitis in the XIPERE study arm experienced clinically significant improvement in vision relative to the control arm, demonstrating the potential efficacy of suprachoroidal injection of XIPERE for the treatment of macular edema associated with uveitis. No serious adverse events (AEs) considered by the investigators related to treatment were reported.

    "The publication of our positive Phase 3 XIPERE clinical trial results is an important milestone for Clearside as it expands the understanding of our suprachoroidal treatment approach," said Thomas A. Ciulla, M.D., MBA, chief medical officer, Clearside Biomedical. "We are coordinating closely with Bausch Health, our exclusive licensee of XIPERE in the United States and Canada, and are excited for the potential to add this treatment option to the repertoire for retinal specialists."

    "We are encouraged by the results of these data as they demonstrated clinically meaningful improvement in vision for nearly half of the patients treated, further supporting the efficacy profile of XIPERE," said Joseph C. Papa, chairman and CEO, Bausch Health. "We look forward to continuing to advance this promising therapy with Clearside, and we are hopeful that, if approved, we will quickly bring forward this potential new treatment option for patients." 

    About the Phase 3 PEACHTREE Study
    The PEACHTREE study was a randomized, controlled, masked, Phase 3 clinical trial that evaluated the safety and efficacy of XIPERE in 160 patients with macular edema associated with noninfectious uveitis. Patients were randomized to receive XIPERE at baseline and at 12 weeks versus control. The PEACHTREE study met its primary endpoint, with 47 percent of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16 percent of patients in the control arm (p<0.001), using the standardized Early Treatment of Diabetic Retinopathy Study scale (visual acuity testing). All key secondary and additional endpoints of the PEACHTREE study were also achieved. No serious AEs considered by the investigators to be related to treatment were reported. Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the XIPERE and control groups, respectively. Cataract AE rates were comparable (7.3% and 6.3%, respectively).

    About XIPERE™
    XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye that is being investigated for the treatment of macular edema associated with uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. An affiliate of Bausch Health acquired the exclusive license for the commercialization and development of XIPERE in the United States and Canada in October 2019.

    About Clearside Biomedical
    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    About Bausch + Lomb
    Bausch + Lomb, the leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see. Its core businesses include over-the-counter products, dietary supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in more than 100 countries. For more information, visit www.bausch.com.  

    About Bausch Health
    Bausch Health Companies Inc. (TSX:BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.

    Cautionary Note Regarding Forward-Looking Statements
    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the timing for resubmitting the XIPERE NDA, the potential approval of XIPERE for the treatment of macular edema associated with uveitis, opportunities for expanding Clearside's internal pipeline, and the potential benefits of XIPERE and the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Bausch Health Forward-looking Statements
    This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of Bausch Health management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in Bausch Health's most recent annual or quarterly report and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

    References:
    1. Steven Y, et al. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3, Randomized Trial. Ophthalmology. 2020: doi:10.1016/j.ophtha.2020.01.006. 

    Any product/brand names are trademarks of the respective owners.  
    XIPERE is a trademark of Clearside Biomedical, Inc. 

    Investor Contact:                                

    Media Contact:

    Arthur Shannon     

    Lainie Keller

           

    (514) 856-3855                               

    (908) 927-0617

    (877) 281-6642 (toll free)                               




    Clearside Biomedical:


    Jenny Kobin


    Remy Bernarda


     


    (678) 430-8206


     

    Bausch Health logo (PRNewsfoto/Bausch Health Companies Inc.)

     

    (PRNewsfoto/Valeant Pharmaceuticals Interna)

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    SOURCE Bausch Health Companies Inc.; Clearside Biomedical, Inc.

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  37. ALPHARETTA, Ga., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the Company will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 16, 2020 at 11:30 a.m. PT.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments…

    ALPHARETTA, Ga., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that the Company will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 16, 2020 at 11:30 a.m. PT.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  38. ALPHARETTA, Ga., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Management will present a company overview at the Stifel 2019 Healthcare Conference in New York, NY on Wednesday, November 20, 2019 at 9:10 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments…

    ALPHARETTA, Ga., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that Management will present a company overview at the Stifel 2019 Healthcare Conference in New York, NY on Wednesday, November 20, 2019 at 9:10 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

    Primary Logo

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  39. – Recent Partnerships Support the Broad Applicability of Suprachoroidal Space Injection Platform to Potentially Treat Multiple Ocular Diseases

    – Suprachoroidal Axitinib IND Submission Targeted for Mid-2020 –  

    – Management to Host Webcast and Conference Call Today at 4:30 P.M. ET –  

    ALPHARETTA, Ga., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the third quarter of 2019 and provided a corporate update.

    "With three recent partnerships and plans to expand our internal development pipeline, we have made meaningful…

    – Recent Partnerships Support the Broad Applicability of Suprachoroidal Space Injection Platform to Potentially Treat Multiple Ocular Diseases

    – Suprachoroidal Axitinib IND Submission Targeted for Mid-2020 –  

    – Management to Host Webcast and Conference Call Today at 4:30 P.M. ET –  

    ALPHARETTA, Ga., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the third quarter of 2019 and provided a corporate update.

    "With three recent partnerships and plans to expand our internal development pipeline, we have made meaningful progress on our overall strategy to broaden the reach of our suprachoroidal space injection platform," said George Lasezkay, Pharm.D., J.D., Clearside's Chief Executive Officer. "Last quarter, we announced our plans to out-license rights to XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) rather than commercialize it on our own, to create external collaborations with other companies enabling access to our platform, and to build an internal pipeline in areas such as gene therapy and small molecules."

    "We have now signed deals with Bausch Health, REGENXBIO and Aura Biosciences that will benefit Clearside in a number of ways: 1) we have eliminated the inherent risks and investment related to building and maintaining a commercial infrastructure for XIPERE ourselves; 2) we are entitled to receive $7 million of non-dilutive capital in upfront payments and are eligible to receive over $200 million in potential future development and sales milestones and royalty payments; and 3) we have expanded the use of our platform to other indications including choroidal melanoma, wet age-related macular degeneration (AMD), and diabetic retinopathy. We look forward to completing the next steps on XIPERE and continuing to expand our pipeline through partner collaborations and planned internal research and development efforts," concluded Dr. Lasezkay.

    Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of Clearside, commented, "With a renewed focus on research and development, our team has spent the last several months performing additional analysis on our proprietary suspension of axitinib (CLS-AX) for suprachoroidal injection and we are now planning to advance this as our next internal development program. Axitinib directly inhibits receptor tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors-1, -2, and -3 with high potency and specificity, and pan-VEGF inhibition may benefit patients who sub-optimally respond to current anti-VEGF therapy. Further, our preclinical testing of CLS-AX using our proprietary microinjector demonstrated reduced growth of experimental neovascularization with decreased fluorescein leakage, and delivered the compound directly to affected tissues with durable drug levels, suggesting the potential to maintain visual gains and reduce clinical treatment burden in patients with angiogenic retinal diseases. Based on our current and planned non-clinical research, we are targeting submission of an Investigational New Drug (IND) application for CLS-AX in mid-2020."

    Clearside is working to address the issues raised by the U.S. Food and Drug Administration (FDA) in the complete response letter received last month regarding XIPERE. The Company currently expects to resubmit its New Drug Application (NDA) in the first quarter of 2020 and believes the FDA will review the NDA within six months of receipt of the resubmission.

    Key Highlights

    • Bausch Health acquired an exclusive license for the commercialization and development of XIPERE in the United States and Canada.
    • REGENXBIO Inc. exercised its option to license Clearside's proprietary, in-office SCS Microinjector for the delivery of adeno-associated virus (AAV)-based therapeutics to the suprachoroidal space to potentially treat wet AMD, diabetic retinopathy, and other conditions for which chronic anti-VEGF treatment is currently the standard of care.
    • Aura Biosciences entered a worldwide licensing agreement for the use of Clearside's SCS Microinjector to deliver Aura's proprietary drug candidates into the suprachoroidal space for the potential treatment of certain ocular cancers, including choroidal melanoma.
    • Multiple oral presentations at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting featured Clearside's suprachoroidal injection platform and potential value of XIPERE in uveitis patients.
    • Presentations were made related to Clearside on gene therapy delivery, additional analysis of XIPERE clinical programs, and the unmet need in diabetic macular edema at global conferences including The Retina Society 52nd Scientific Program in London, UK, the Ophthalmology Futures Forum in Paris, France and the European Society of Retina Specialists EURETINA 2019 Congress in Paris, France.

    Third Quarter 2019 Financial Results

    Clearside's research and development expenses for the quarter ended September 30, 2019 were $2.7 million, compared to $20.1 million for the quarter ended September 30, 2018. The $17.4 million decrease was primarily attributable to closing down two late-stage clinical trials in early 2019. General and administrative expenses were $3.8 million for the quarter ended September 30, 2019, compared to $3.9 million for the quarter ended September 30, 2018.

    Net loss for the quarter ended September 30, 2019 was $6.5 million, or $0.17 per share of common stock, compared to $23.9 million for the quarter ended September 30, 2018, or $0.75 per share of common stock. The decrease in net loss was primarily related to lower clinical development costs.

    Cash and cash equivalents totaled $22.6 million as of September 30, 2019.

    Conference Call & Webcast Details

    Clearside's management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 1137365. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the timing for resubmitting the XIPERE NDA and submitting the IND for CLS-AX, plans to expand Clearside's internal pipeline and enter into other licensing arrangements, the potential benefits of CLS-AX and the SCS injection platform and the potential approval of XIPERE for the treatment of macular edema associated with uveitis. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    -Financial Tables Follow-


    CLEARSIDE BIOMEDICAL, INC.
    Selected Financial Data
    (in thousands, except share and per share data)
    (unaudited)

    Statements of Operations Data Three Months Ended
    September 30,
        Nine Months Ended
    September 30,
     
      2019     2018     2019     2018  
    Collaboration revenue $ 141     $     $ 231     $  
    Operating expenses:                              
    Research and development   2,728       20,083       14,353       50,805  
    General and administrative   3,781       3,873       13,169       10,508  
    Total operating expenses   6,509       23,956       27,522       61,313  
    Loss from operations   (6,368 )     (23,956 )     (27,291 )     (61,313 )
    Other (expense) income, net   (168 )     84       (383 )     133  
    Net loss $ (6,536 )   $ (23,872 )   $ (27,674 )   $ (61,180 )
    Net loss per share of common stock — basic and diluted $ (0.17 )   $ (0.75 )   $ (0.75 )   $ (2.02 )
    Weighted average shares outstanding — basic and diluted   38,414,751       32,024,223       36,747,314       30,292,909  


               
    Balance Sheet Data September 30,     December 31,  
      2019     2018  
                   
    Cash, cash equivalents and short-term investments $ 22,551     $ 40,878  
    Restricted cash   360       360  
    Total assets   25,867       44,120  
    Long-term debt (including current portion)   10,162       9,975  
    Total liabilities   16,108       20,500  
    Total stockholders' equity   9,759       23,620  

    Source: Clearside Biomedical, Inc.

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  40. ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial…

    ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.

    "Our recent partnerships with REGENXBIO, Bausch Health, and Aura Biosciences demonstrate the broad applicability of our suprachoroidal space injection platform to potentially treat multiple ocular diseases including wet AMD, uveitic macular edema, and choroidal melanoma. With these collaborations and planned internal research and development efforts, we look forward to continuing to expand our pipeline," said George Lasezkay, Pharm.D., J.D., Chief Executive Officer of Clearside.

    "Results from multiple preclinical studies support the potential safety and effectiveness of suprachoroidally administered AAV-based gene therapy, and we are excited to advance our partnership with REGENXBIO," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of Clearside. "Wet AMD and diabetic retinopathy are the two most common causes of irreversible blindness in the United States, and several large ‘real world' studies reveal under-treatment and outcomes that fall short of those reported in clinical trials. Utilizing our SCS Microinjector, delivery of RGX-314 may provide patients with access to one-time gene therapy treatment in a range of patient care settings."

    Under the terms of the option and license agreement, Clearside earned $2.0 million related to REGENXBIO's exercise of the option and signing of the original research agreement. Clearside is also eligible to receive up to $34 million in total development milestones across multiple indications, up to $102 million in sales milestones and mid-single digit royalties on net sales of products using the SCS Microinjector. REGENXBIO will be responsible for all development, regulatory and commercialization activities for their gene therapy product candidates. Clearside will be responsible for supplying the SCS Microinjector in support of REGENXBIO's preclinical studies, clinical studies and commercial use.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential application of the SCS Microinjector for AAV gene therapy and the potential benefits of the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

    Primary Logo

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  41. ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial…

    ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.

    "Our recent partnerships with REGENXBIO, Bausch Health, and Aura Biosciences demonstrate the broad applicability of our suprachoroidal space injection platform to potentially treat multiple ocular diseases including wet AMD, uveitic macular edema, and choroidal melanoma. With these collaborations and planned internal research and development efforts, we look forward to continuing to expand our pipeline," said George Lasezkay, Pharm.D., J.D., Chief Executive Officer of Clearside.

    "Results from multiple preclinical studies support the potential safety and effectiveness of suprachoroidally administered AAV-based gene therapy, and we are excited to advance our partnership with REGENXBIO," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of Clearside. "Wet AMD and diabetic retinopathy are the two most common causes of irreversible blindness in the United States, and several large ‘real world' studies reveal under-treatment and outcomes that fall short of those reported in clinical trials. Utilizing our SCS Microinjector, delivery of RGX-314 may provide patients with access to one-time gene therapy treatment in a range of patient care settings."

    Under the terms of the option and license agreement, Clearside earned $2.0 million related to REGENXBIO's exercise of the option and signing of the original research agreement. Clearside is also eligible to receive up to $34 million in total development milestones across multiple indications, up to $102 million in sales milestones and mid-single digit royalties on net sales of products using the SCS Microinjector. REGENXBIO will be responsible for all development, regulatory and commercialization activities for their gene therapy product candidates. Clearside will be responsible for supplying the SCS Microinjector in support of REGENXBIO's preclinical studies, clinical studies and commercial use.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential application of the SCS Microinjector for AAV gene therapy and the potential benefits of the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  42. ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial…

    ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.

    "Our recent partnerships with REGENXBIO, Bausch Health, and Aura Biosciences demonstrate the broad applicability of our suprachoroidal space injection platform to potentially treat multiple ocular diseases including wet AMD, uveitic macular edema, and choroidal melanoma. With these collaborations and planned internal research and development efforts, we look forward to continuing to expand our pipeline," said George Lasezkay, Pharm.D., J.D., Chief Executive Officer of Clearside.

    "Results from multiple preclinical studies support the potential safety and effectiveness of suprachoroidally administered AAV-based gene therapy, and we are excited to advance our partnership with REGENXBIO," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of Clearside. "Wet AMD and diabetic retinopathy are the two most common causes of irreversible blindness in the United States, and several large ‘real world' studies reveal under-treatment and outcomes that fall short of those reported in clinical trials. Utilizing our SCS Microinjector, delivery of RGX-314 may provide patients with access to one-time gene therapy treatment in a range of patient care settings."

    Under the terms of the option and license agreement, Clearside earned $2.0 million related to REGENXBIO's exercise of the option and signing of the original research agreement. Clearside is also eligible to receive up to $34 million in total development milestones across multiple indications, up to $102 million in sales milestones and mid-single digit royalties on net sales of products using the SCS Microinjector. REGENXBIO will be responsible for all development, regulatory and commercialization activities for their gene therapy product candidates. Clearside will be responsible for supplying the SCS Microinjector in support of REGENXBIO's preclinical studies, clinical studies and commercial use.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential application of the SCS Microinjector for AAV gene therapy and the potential benefits of the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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  43. ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial…

    ALPHARETTA, Ga., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that REGENXBIO Inc. (NASDAQ:RGNX) has exercised its option under the previously announced option and license agreement to license Clearside's proprietary, in-office SCS Microinjector™ for the delivery of adeno-associated virus (AAV)-based therapeutics, including but not limited to RGX-314 delivery to the suprachoroidal space to potentially treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other conditions for which chronic anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care.

    "Our recent partnerships with REGENXBIO, Bausch Health, and Aura Biosciences demonstrate the broad applicability of our suprachoroidal space injection platform to potentially treat multiple ocular diseases including wet AMD, uveitic macular edema, and choroidal melanoma. With these collaborations and planned internal research and development efforts, we look forward to continuing to expand our pipeline," said George Lasezkay, Pharm.D., J.D., Chief Executive Officer of Clearside.

    "Results from multiple preclinical studies support the potential safety and effectiveness of suprachoroidally administered AAV-based gene therapy, and we are excited to advance our partnership with REGENXBIO," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of Clearside. "Wet AMD and diabetic retinopathy are the two most common causes of irreversible blindness in the United States, and several large ‘real world' studies reveal under-treatment and outcomes that fall short of those reported in clinical trials. Utilizing our SCS Microinjector, delivery of RGX-314 may provide patients with access to one-time gene therapy treatment in a range of patient care settings."

    Under the terms of the option and license agreement, Clearside earned $2.0 million related to REGENXBIO's exercise of the option and signing of the original research agreement. Clearside is also eligible to receive up to $34 million in total development milestones across multiple indications, up to $102 million in sales milestones and mid-single digit royalties on net sales of products using the SCS Microinjector. REGENXBIO will be responsible for all development, regulatory and commercialization activities for their gene therapy product candidates. Clearside will be responsible for supplying the SCS Microinjector in support of REGENXBIO's preclinical studies, clinical studies and commercial use.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential application of the SCS Microinjector for AAV gene therapy and the potential benefits of the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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    View Full Article Hide Full Article
  44. ALPHARETTA, Ga., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space will be given at the upcoming American Academy of Ophthalmology (AAO) 2019 Annual Meeting taking place October 12-15, 2019 in San Francisco, California. 

    Presentation Details:

    Title: Suprachoroidal CLS-TA and IOP: Results from the Phase 3 PEACHTREE Clinical Trial
    Author: Steven Yeh, M.D., Associate Professor, Emory Eye Center
    Date/Time: Sunday, October

    ALPHARETTA, Ga., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside's pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space will be given at the upcoming American Academy of Ophthalmology (AAO) 2019 Annual Meeting taking place October 12-15, 2019 in San Francisco, California. 

    Presentation Details:

    Title: Suprachoroidal CLS-TA and IOP: Results from the Phase 3 PEACHTREE Clinical Trial
    Author: Steven Yeh, M.D., Associate Professor, Emory Eye Center
    Date/Time: Sunday, October 13th / 3:15 p.m.; also available as an ePoster
    Poster #: PO522
       
    Title: Suprachoroidal Delivery for Ocular Gene Therapy: Nonclinical Experiments Evaluating Nonviral DNA Nanoparticles
    Author:  Christine N. Kay, M.D., Vitreo Retinal Associates; Affiliate Assistant Professor in the Department of Ophthalmology, University of South Florida
    Date/Time: Sunday, October 13th / 5:00 p.m.; also available as an ePoster
    Poster #: PO395
       
    Title: A Subgroup Analysis of Subjects Diagnosed With Anterior Uveitis From the Phase 3 PEACHTREE Clinical Trial
    Author: Ashleigh L. Levison, M.D., Colorado Retina Associates
    Date/Time: Monday, October 14th / 8:30 a.m.
    Paper #: PA031
       
    Title: Disorganization of the Retinal Inner Layers as a Biomarker: Results of the TYBEE Phase 2 in DME
    Author: Michael S. Ip, M.D., Doheny Eye Institute, David Geffen School of Medicine at University of California Los Angeles, CA
    Date/Time: ePoster
    Poster #: PO485

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential to bring XIPERE to market for uveitis patients, opportunities for expanding Clearside's internal pipeline, and the potential benefits of XIPERE and the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

    Primary Logo

    View Full Article Hide Full Article
  45. ALPHARETTA, Ga., Sept. 19, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that numerous presentations were given at three scientific congresses in Europe over the past two weeks.

    "Clearside was well represented at three prominent medical meetings in Europe with featured presentations on gene therapy delivery, additional analysis of our XIPERE™ clinical programs, and the unmet need in diabetic macular edema," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer. "We were pleased to be a part of the numerous discussions around gene therapy and the…

    ALPHARETTA, Ga., Sept. 19, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that numerous presentations were given at three scientific congresses in Europe over the past two weeks.

    "Clearside was well represented at three prominent medical meetings in Europe with featured presentations on gene therapy delivery, additional analysis of our XIPERE™ clinical programs, and the unmet need in diabetic macular edema," said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer. "We were pleased to be a part of the numerous discussions around gene therapy and the potential for suprachoroidal delivery to enhance treatment options in this area. The uveitis and retina communities are increasingly supportive of our efforts to bring XIPERE to market, if approved, for their uveitis patients, as well as our progress in gene therapy, small molecules, and delivery of ocular oncology therapies. We look forward to working closely with our partners and seeking indications internally to expand our pipeline."

    Conference: Ophthalmology Futures Forum, Retina 2019, September 3, 2019, Paris, France
       
    Session: Safety, Vectors and Routes of Delivery for Stem Cells and Gene Therapy
       
    Summary: Clearside's Dr. Thomas Ciulla joined other academic and industry experts in the discussion of stem cells and gene therapy. The session reviewed novel endpoints, immune responses, and delivery methods for gene therapy, highlighting suprachoroidal administration and its potential for enhanced patient access to office-based gene therapy, as well as the potential for enhanced delivery to the retina.


    Conference: European Society of Retina Specialists EURETINA 2019 Congress, September 5-8, 2019, Paris, France
       
    Title: Suprachoroidal CLS-TA Improves Patient Outcomes in Uveitis of All Anatomic Subtypes: Results of the Phase 3 PEACHTREE Study
       
    Author: Ron Neumann, M.D., Co-Chairperson ISOPT Clinical, Ocular Drug Development Expert
       
    Summary: Dr. Neumann presented an electronic poster for the event reviewing the results of Clearside's Phase 3, PEACHTREE study for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA. The PEACHTREE study was the first pivotal trial specifically studying macular edema due to non-infectious uveitis and the first uveitis trial with a primary endpoint of visual acuity, a significant and clinically meaningful outcome for both physicians and patients. The 96 patients treated with suprachoroidally injected CLS-TA had been diagnosed with non-infectious uveitis involving any anatomic location, reflective of clinical practice. The primary endpoint of the trial was met with nearly 1 of 2 patients experiencing a 3-line visual gain, and 1 of 2 patients experiencing resolution of macular edema. The results were consistent regardless of the anatomical location of the uveitis. There were no serious adverse events attributable to CLS-TA, and there were low rates of elevated intraocular pressure. Cataract adverse events were similar between treatment and control groups and the vast majority of CLS-TA patients did not need rescue therapy.


    Conference: The Retina Society 52nd Scientific Program, September 11-15, 2019 London, UK
       
    Title: Suprachoroidal Triamcinolone Acetonide Suspension (CLS-TA) and Intraocular Pressure: Results from the Phase 3 PEACHTREE Clinical Trial for Uveitis
       
    Author: Pauline Merrill, M.D., Illinois Retina Associates, Rush University Medical Center
       
    Summary: Dr. Merrill gave an extensive presentation on the results of PEACHTREE with a focus on intraocular pressure (IOP). With respect to IOP-related adverse events (AEs), the rate was 12% in the suprachoroidal CLS-TA treatment group compared to 16% in the control group. Rescue medications were required in 72% of the patients in the control group.  Ten patients in the control group experienced IOP-related AEs and each received intravitreal steroids as their rescue therapy. There were no glaucoma surgeries in either group. Further analysis found that IOP ≥ 30mmHg was observed in 5% of CLS-TA treated eyes (n=83) compared to 11% of the control eyes which received rescue treatment (n=46). Similarly, IOP lowering medications were used in fewer eyes treated with suprachoroidal triamcinolone acetonide (7%) compared to the control eyes receiving rescue treatment (13%).
       
    Title: Suprachoroidal Injection of CLS-TA in Uveitis Maintains Efficacy Outcomes Through 48-weeks: Results of the MAGNOLIA Phase 3 Extension Study
       
    Author: Sumit Sharma, M.D., Vitreoretinal Surgery and Uveitis Physician, Cleveland Clinic
       
    Summary: In the MAGNOLIA extension study, CLS-TA-treated patients maintained mean improvements of 12 letters through week 48 after their initial treatment. Half of patients did not require additional medication 36 weeks after their last injection of CLS-TA.
       
    Title:  Visual Acuity Outcomes and Anti-Vascular Endothelial Growth Factor Therapy Intensity in Diabetic Macular Edema: A "Real World" Analysis in 28,456 Eyes
       
    Author: Thomas A Ciulla, M.D., MBA, Clearside Chief Medical Officer
       
    Summary: Although the introduction of anti-VEGF agents has led to notably improved outcomes for patients with diabetic macular edema (DME), there are several practical limitations, including the need for frequent injections and incomplete response in some patients. Consequently, "real world" DME treatment compliance can be poor. This analysis of 28,456 eyes showed that "real world" DME patients are under-treated and their resulting visual outcomes following anti-VEGF therapy are meaningfully less than those seen in clinical trials. This analysis demonstrates a large unmet need for DME therapies that address treatment burden and incomplete response.
       

    These presentations will be available on Clearside's website in the Publications section under Programs (https://www.clearsidebio.com/publications.htm).

    About XIPERE™

    XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside's patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye, thus potentially providing advantageous and sustained efficacy with a favorable safety profile.

    About PEACHTREE

    PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, and compared XIPERE dosed every 12 weeks to sham control. The PEACHTREE trial met its primary endpoint, with 47% of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16% of patients in the sham control arm (p<0.001), using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing. All key secondary and additional endpoints of the PEACHTREE trial were also achieved.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential to bring XIPERE to market for uveitis patients, opportunities for expanding Clearside's internal pipeline, and the potential benefits of XIPERE and the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

    Primary Logo

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  46. ROCKVILLE, Md. and ALPHARETTA, Ga., Sept. 4, 2019 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today announced an option and license agreement for exclusive worldwide rights to Clearside's proprietary, in-office SCS Microinjector for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and…

    ROCKVILLE, Md. and ALPHARETTA, Ga., Sept. 4, 2019 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today announced an option and license agreement for exclusive worldwide rights to Clearside's proprietary, in-office SCS Microinjector for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other conditions for which anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care. REGENXBIO plans to evaluate RGX-314 using Clearside's SCS Microinjector for in-office, non-surgical delivery into the suprachoroidal space, while continuing to advance its RGX-314 subretinal delivery program currently in development for wet AMD and DR.

    Delivery of NAV AAV8-based gene therapy through the suprachoroidal space can potentially provide a targeted, in-office, non-surgical approach to obtaining widespread transgene expression in the retina without exposing the vitreous and the anterior segment of the eye to the injected drug. Clearside's patented SCS Microinjector is specifically designed to allow for consistent injection into the suprachoroidal space and has been tested in over 1,000 injections in clinical trials to date.

    "We are pleased to partner with Clearside in evaluating the use of the SCS Microinjector to deliver RGX-314 to the suprachoroidal space in the eye. We believe this approach can potentially allow for the treatment of an expanded population of patients with wet AMD and DR by providing access to gene therapy treatment in all settings of patient care," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "Delivery into the suprachoroidal space, which in clinical trials has demonstrated minimal associated procedural risks, may allow physicians to treat patients with diseases like DR earlier in the disease course with RGX-314. We will continue to advance the RGX-314 subretinal delivery clinical program, with a Phase IIb clinical trial in wet AMD and a Phase II clinical trial in DR expected to begin by the end of 2019, and we look forward to moving both delivery approaches through development as part of our deep commitment to patients."

    "REGENXBIO is the ideal partner for us given its leadership, expertise and pioneering work in the development and manufacturing of AAV vectors for the delivery of anti-VEGF therapeutic antibodies in the ophthalmology space," said George Lasezkay, Pharm.D., J.D., Chief Executive Officer of Clearside. "We are excited by the recent positive interim data reported by REGENXBIO from the current RGX-314 Phase I/IIa trial in wet AMD. This is an exciting time for us to collaborate with REGENXBIO to evaluate the potential application of our proprietary in-office SCS Microinjector for AAV gene therapy."

    A recent research collaboration with Johns Hopkins School of Medicine published in The Journal of Clinical Investigation1 highlights the potential of RGX-314 gene therapy delivered into the suprachoroidal space. In these preclinical studies, delivery of RGX-314 into the suprachoroidal space resulted in similar expression of anti-VEGF Fab and suppression of VEGF-induced vascular leakage as subretinal delivery.

    "Intravitreal delivery of AAV gene therapy can be limited by ocular inflammation, immune responses in the vitreous and restrictive physical transduction barriers due to the inner limiting membrane on the retina. These hurdles can potentially be overcome with alternative in-office delivery approaches such as delivery to the suprachoroidal space," said Olivier Danos, Ph.D., Chief Scientific Officer of REGENXBIO. "Preclinical suprachoroidal delivery studies conducted with the Johns Hopkins University School of Medicine demonstrated encouraging initial results in multiple animal species, and we look forward to further evaluation of this route of administration for RGX-314."

    "Following on the positive long-term clinical results from RGX-314 delivered subretinally, it is exciting to see that preliminary preclinical studies with suprachoroidal delivery of RGX-314 achieved widespread transgene expression in the retina, similar to what was observed in RGX-314 preclinical studies using subretinal delivery. Suprachoroidal delivery of gene therapy has the opportunity for broad transduction of the retina and has the potential to be the preferred choice for in-office treatment of wet AMD, DR and other chronic retinal diseases," said Robert Avery, M.D., study investigator from California Retina Consultants in Santa Barbara, CA. "I am thrilled to see REGENXBIO evaluating an in-office procedure in addition to the on-going RGX-314 subretinal delivery program, which has the potential to provide multiple treatment options to patients with significant unmet needs."

    Under the terms of the agreement, Clearside has granted REGENXBIO an option to receive an exclusive, worldwide commercial license, with rights to sublicense, to Clearside's SCS Microinjector for the delivery of AAV gene therapies for the treatment of wet AMD, DR, and other conditions for which chronic anti-VEGF treatment is currently the standard of care. In return for these rights, Clearside will receive a fee upon REGENXBIO's exercise of its option, as well as up to $34 million in total development milestones across multiple indications, up to $102 million in sales milestones and mid-single digit royalties on net sales of products using the SCS Microinjector. REGENXBIO will be responsible for all development and commercialization activities for gene therapy product candidates. Clearside will be responsible for supplying the SCS Microinjector and supporting REGENXBIO's preclinical studies, clinical studies and commercial use.

    About RGX-314

    RGX-314 is being developed as a potential one-time treatment for wet AMD, DR and other additional chronic retinal conditions treated with anti-VEGF. RGX-314 consists of the NAV AAV8 vector encoding an antibody fragment which inhibits VEGF, modifying the pathway for formation of new leaky blood vessels which lead to retinal fluid accumulation and vision loss. In REGENXBIO's on-going clinical trial in subjects with wet AMD, dose-dependent increases in protein expression levels across five cohorts have been seen, and 50% of Cohort 3 subjects continued to be free of anti-VEGF injections at 18 months following a single subretinal administration of RGX-314.

    About REGENXBIO Inc.

    REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas. For more information, visit http://www.regenxbio.com.

    About Clearside Biomedical, Inc.

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of the disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    REGENXBIO Forward-Looking Statements

    This press release includes "forward-looking statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO's future operations, preclinical studies, clinical trials and cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the year ended December 31, 2018, and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC's website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    Clearside Forward-Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential application of the SCS Microinjector for AAV gene therapy and the potential benefits of the SCS injection platform. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission ("SEC") on March 15, 2019, Clearside's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 2019, and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    1. Ding, K., Shen, J., Hafiz, Z., Hackett, S. F., Silva, R. L. E., Khan, M., … Campochiaro, P. A. (2019). AAV8-vectored suprachoroidal gene transfer produces widespread ocular transgene expression. Journal of Clinical Investigation. doi: 10.1172/jci129085

    Contacts:

    For REGENXBIO

    Tricia Truehart
    Investor Relations and Corporate Communications
    347-926-7709

    Investors:
    Heather Savelle, 212-600-1902

    Media:
    David Rosen, 212-600-1902

    For CLEARSIDE

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    (PRNewsfoto/REGENXBIO Inc.)

     

    (PRNewsfoto/REGENXBIO Inc.)

     

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    SOURCE REGENXBIO Inc.; Clearside Biomedical, Inc.

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  47. ALPHARETTA, Ga., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., Chief Executive Officer, will present a company overview at the Janney Montgomery Scott Healthcare Conference in New York, NY on Tuesday, September 10, 2019 at 8:15 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical…

    ALPHARETTA, Ga., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that George Lasezkay, Pharm.D., J.D., Chief Executive Officer, will present a company overview at the Janney Montgomery Scott Healthcare Conference in New York, NY on Tuesday, September 10, 2019 at 8:15 a.m. ET.

    A link to the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months.

    About Clearside Biomedical

    Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside's proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company's SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

    Investor and Media Contacts:

    Jenny Kobin
    Remy Bernarda

    (678) 430-8206

    Source: Clearside Biomedical, Inc.

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