CLSD Clearside Biomedical Inc.

3.31
+0.06  (+2%)
Previous Close 3.25
Open 3.29
52 Week Low 1.1
52 Week High 4.53
Market Cap $189,204,783
Shares 57,161,566
Float 46,621,586
Enterprise Value $186,704,865
Volume 409,060
Av. Daily Volume 994,666
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Upcoming Catalysts

Drug Stage Catalyst Date
XIPERE (Suprachoroidal CLS-TA)
Macular edema associated with non-infectious uveitis
NDA Filing
NDA Filing
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CLS-AX
Wet age-related macular degeneration
Phase 1/2
Phase 1/2
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RGX-314 (AAVIATE)
Wet AMD using suprachoroidal delivery
Phase 2
Phase 2
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RGX-314 - ALTITUDE
Diabetic retinopathy
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
RGX-314 (ATMOSPHERE)
Wet AMD
Phase 2/3
Phase 2/3
Phase 2/3 trial is enrolling.
AU-011
Primary choroidal melanoma
Phase 2
Phase 2
Phase 2 initiation of dosing announced September 11, 2020.
Suprachoroidal CLS-TA - SAPPHIRE
Macular edema associated with retinal vein occlusion (RVO)
Phase 3
Phase 3
Phase 3 data released November 5, 2018 did not meet primary endpoint.
Suprachoroidal CLS-TA - TYBEE
Diabetic Macular Edema (DME)
Phase 2
Phase 2
Phase 2 data released May 31, 2018 - mixed data. 12.3 ETDRS letters compared to 13.5 ETDRS letters in control arm.

Latest News

  1. 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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  2. 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
  3. 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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  4. - 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.



    Primary Logo

    View Full Article Hide Full Article
  5. 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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