GRAY Graybug Vision Inc.

4.16
+0.09  (+2%)
Previous Close 4.07
Open 4.1
52 Week Low 3.43
52 Week High 37.8799
Market Cap $87,592,727
Shares 21,055,944
Float 11,534,062
Enterprise Value $9,692
Volume 184,982
Av. Daily Volume 2,654,629
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Upcoming Catalysts

Drug Stage Catalyst Date
GB-102 (ALTISSIMO)
Wet age-related macular degeneration
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
GB-401
Glaucoma
Phase 1
Phase 1
Phase 1 trial to commence 1H 2022.
GB-102
Diabetic macular edema (DME)
Phase 2b
Phase 2b
Phase 2b trial to be initiated 2H 2021.
GB-102
Wet age-related macular degeneration (AMD)
Phase 3
Phase 3
Phase 3 trials to be initiated 2H 2021.

Latest News

  1. Amy Burroughs and Dr. Charles Semba Bring Extensive and Complementary Experience in Building Specialty Therapeutics Companies

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today the election of two industry veterans to the Company's Board of Directors. Amy Burroughs, President and CEO of Cleave Therapeutics, brings over 20 years of experience in business and commercial development, strategy and leadership in the pharmaceutical industry. Dr. Charles Semba, Chief Medical Officer of Eluminex Biosciences, has over 20 years of drug-development experience in high growth public and private therapeutics companies…

    Amy Burroughs and Dr. Charles Semba Bring Extensive and Complementary Experience in Building Specialty Therapeutics Companies

    DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today the election of two industry veterans to the Company's Board of Directors. Amy Burroughs, President and CEO of Cleave Therapeutics, brings over 20 years of experience in business and commercial development, strategy and leadership in the pharmaceutical industry. Dr. Charles Semba, Chief Medical Officer of Eluminex Biosciences, has over 20 years of drug-development experience in high growth public and private therapeutics companies and serves on the faculty of Vascular/Interventional Radiology at Stanford University.

    "Amy and Charles have the perfect mix of experience to bring to our board at this stage of the company," said Rick Pauls, President and Chief Executive Officer of DiaMedica. "Their strategic, clinical and commercial insights will add significant value as we advance the development of DM199 to pivotal trials and expand our management team."

    Amy Burroughs

    Amy Burroughs has held senior leadership and advisory roles with a broad range of public and private biopharmaceutical companies over the last 20 years. She is currently president and chief executive officer of Cleave Therapeutics, a clinical stage, venture backed oncology company. Previously, she served as executive in residence at 5AM Ventures, a leading venture capital firm focused on building next-generation life science companies, and a senior advisor to Crinetics (NASDAQ:CRNX). Ms. Burroughs' career also includes consulting with Egon Zehnder in leadership development, talent and corporate governance for life sciences companies. She began her biopharmaceutical career at Genentech, where she held key roles in commercial strategy and planning across the portfolio and led the neurology commercial team. Ms. Burroughs holds a BA degree in computer science and economics from Dartmouth and an MBA from Harvard University.

    Charles Semba, MD

    Dr. Charles Semba has over 20 years of drug development experience in public and private biotechnology companies and is a recognized expert in endovascular therapy, thrombolysis, mechanical thrombectomy, and endovascular surgery. He is Chief Medical Officer (CMO) at Eluminex Biosciences and has served as CMO for SARcode Bioscience (acquired by Shire/Takeda), ForSight VISION5 (acquired by Allergan), and Graybug Vision (NASDAQ:GRAY). He has held senior leadership roles as Vice President Ophthalmic Medicine at Shire/Takeda and Ophthalmology Group Head at Genentech. Dr. Semba led the clinical development of ranibizumab (LUCENTIS®), the first global blockbuster anti-VEGF agent to reverse blindness in wet age-related macular degeneration and lifitegrast (XIIDRA®), the first novel agent for the treatment of both signs and symptoms of dry eye disease; XIIDRA was acquired by Novartis for over $5 billion (USD). He also led FDA approval for CathFlo Activase® (Alteplase). Dr. Semba holds an MD from University of Minnesota and is an Adjunct Professor of Vascular/Interventional Radiology at Stanford University.

    About DiaMedica Therapeutics

    DiaMedica Therapeutics is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. Our lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke (AIS) and chronic kidney disease (CKD). Based on promising early clinical results, we are advancing DM199 in our REMEDY Phase 2/3 trial in the treatment of AIS and completing enrollment in our REDUX Phase 2 trial for the treatment of certain rare and significant unmet causes of CKD. For more information visit our website at www.diamedica.com.

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  2. REDWOOD CITY, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided an update on recent corporate developments and reported financial results for the quarter ended March 31, 2021.

    Recent Corporate Developments

    • Full-data analysis from 12-month treatment phase of ALTISSIMO Phase 2b trial in wet AMD— GB-102 1mg has shown competitive durability and anatomical control versus aflibercept; trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients.
    • Six-month observational trial extension of ALTISSIMO still underway— 14…

    REDWOOD CITY, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided an update on recent corporate developments and reported financial results for the quarter ended March 31, 2021.

    Recent Corporate Developments

    • Full-data analysis from 12-month treatment phase of ALTISSIMO Phase 2b trial in wet AMD— GB-102 1mg has shown competitive durability and anatomical control versus aflibercept; trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients.
    • Six-month observational trial extension of ALTISSIMO still underway— 14 of 28 patients enrolled have completed at least five months of the extension period without requiring additional supportive therapy, with six of those having completed all six months. 
    • Seeking partner for funding of additional wet AMD clinical trials— Enhanced formulations of GB-102 being developed and preclinical work progressing in parallel.

    • Clinical focus shifting to advancement of GB-401 implant for glaucoma— Disclosed development of implant technology for GB-401 with potential application to GB-102.

    Anticipated Milestones

    • Complete six-month observational trial extension of ALTISSIMO by June 2021, with topline data expected in 3Q 2021.
    • Expected to present full results of ALTISSIMO trial at a medical conference in 4Q 2021.
    • Submit Investigational New Drug (IND) application for GB-401, an injectable formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, in the first half of 2022.
    • Commence a Phase 1 trial for GB-401 implant in glaucoma in the first half of 2022.

    First Quarter 2021 Financial Results

    Net loss for the quarter ended March 31, 2021 was $11.4 million compared to $7.8 million for the same period in 2020.

    Research and development expense for the quarter ended March 31, 2021 was $6.4 million compared to $6.1 million for the same period in 2020. The increase was primarily due to fees incurred upon the cancellation of clinical supply orders for the GB-102 Phase 3 trial and increased compensation costs, offset in part by a reduction in clinical trial expenses due to the completion of the treatment phase of the ALTISSIMO trial in December 2020.

    General and administrative expense for the quarter ended March 31, 2021 was $5.0 million compared to $1.7 million for the same period in 2020. The increase in 2021 was primarily due to the write-off of deposits on fixed assets purchase commitments, an increase in stock-based compensation and an increase in headcount, and the increased cost of additional directors and officers insurance as a result of becoming a public company.

    As of March 31, 2021, the company's cash, cash equivalents, and short-term investments totaled $85.7 million, compared to $95.0 million as of December 31, 2020. The decrease was primarily due to the loss from operations of $11.5 million. The company's current cash and investments are sufficient to support its currently planned operations into the first half of 2023.

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug's other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained-release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding the company's clinical pipeline, its ability to identify a partner to advance the development of GB-102 for wet AMD, the timing or outcomes of its interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through preclinical or clinical development, its ability to timely secure a partner to fund further development of GB-102 on reasonable terms if at all, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, the company's operating results and use of cash, the company's operations as a public company, the company's management and board of directors, and the timing, cost, and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading "Risk Factors" in the company's annual report on Form 10-K filed for the year ended December 31, 2020, and the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Investor Contact



    (650) 487-2409



    Media Contact



    (404) 384-0067

    GRAYBUG VISION, INC.

    Condensed Statements of Operations

    (In thousands, except share and per share amounts; unaudited)

      Three Months Ended March 31, 
      2021   2020  
    Operating expenses:        
    Research and development $6,448   $6,085  
    General and administrative  5,040    1,711  
    Total operating expenses  11,488    7,796  
    Loss from operations  (11,488)   (7,796) 
    Interest income  39    108  
    Change in fair value of preferred stock tranche obligation      (106) 
    Net loss  (11,449)   (7,794) 
    Cumulative dividends on convertible preferred stock      (1,299) 
    Net loss attributable to common stockholders $(11,449)  $(9,093) 
    Net loss per common share—basic and diluted $(0.54)  $(6.61) 
    Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted  21,020,378    1,375,177  



    GRAYBUG VISION, INC.


    Condensed Balance Sheets

    (In thousands)

     March 31,   December 31, 
     2021   2020  
      (unaudited)   (audited) 
    Assets       
    Current assets:       
    Cash and cash equivalents$10,589   $33,418  
    Short-term investments 75,099    61,615  
    Prepaid expenses and other current assets 3,133    4,207  
    Total current assets 88,821    99,240  
    Property and equipment, net 2,002    1,946  
    Prepaid expenses and other non-current assets 29    608  
    Total assets$90,852   $101,794  
    Liabilities, Convertible Preferred Stock and Stockholders' Equity       
    Current liabilities:       
    Accounts payable$1,956   $2,513  
    Accrued research and development 2,097    1,356  
    Other current liabilities 2,225    3,128  
    Total current liabilities 6,278    6,997  
    Deferred rent, long term portion 12    11  
    Total liabilities 6,290    7,008  
    Commitments and contingencies       
    Convertible preferred stock       
    Stockholders' Equity:       
    Preferred stock       
    Common stock 2    2  
    Additional paid-in capital 229,376    228,155  
    Accumulated deficit (144,816)   (133,367) 
    Accumulated other comprehensive loss     (4) 
    Total stockholders' equity 84,562    94,786  
    Total liabilities, convertible preferred stock and stockholders' equity$90,852   $101,794  

     



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    • GB-102 1mg has shown competitive durability and anatomical control versus aflibercept
    • Trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients
    • Developing enhanced formulations and seeking partner funding for additional clinical trials of GB-102
    • Focus on advancing GB-401 implant for glaucoma
    • Current cash sufficient to support planned operations into 2023

    Management to host webcast/conference call today at 8 a.m. ET

    REDWOOD CITY, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided full-data analysis from the 12-month…

    • GB-102 1mg has shown competitive durability and anatomical control versus aflibercept
    • Trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients
    • Developing enhanced formulations and seeking partner funding for additional clinical trials of GB-102
    • Focus on advancing GB-401 implant for glaucoma
    • Current cash sufficient to support planned operations into 2023

    Management to host webcast/conference call today at 8 a.m. ET

    REDWOOD CITY, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided full-data analysis from the 12-month treatment phase of its Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug's proprietary formulation of sunitinib malate injected twice-a-year intravitreally.

    The ALTISSIMO trial is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States. The primary endpoint is median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints are safety and pharmacodynamics, measured as mean change of best-corrected visual acuity (BCVA) and mean change of central subfield thickness (CST) of the retina.

    The ALTISSIMO full-data analysis focused on the GB-102 1mg arm as compared to aflibercept and the pre-enrollment period, excluding results from the GB-102 2mg arm. As previously reported, the development of GB-102 2mg was terminated in 2020 following an interim safety analysis. The trial was not powered to assess non-inferiority to aflibercept.

    Overall, GB-102 1mg was safe and well-tolerated. No drug-related serious adverse events or vision-threatening inflammation were reported. The majority of drug-related adverse events were mild to moderate. Particle migration to the anterior chamber in patients treated with GB-102 1mg was reduced by 79% as compared to GB-102 1mg patients in the ADAGIO Phase 1/2a trial (4/51 injections vs. 3/8), and no surgical interventions were required.

    As previously reported, patients in the GB-102 1mg trial arm (n=21) had a median time to first supportive therapy of five months, and 48% of patients did not require supportive therapy for at least six months. An additional analysis showed the injection frequency was reduced by 58% compared to patients' treatment prior to enrollment in the trial.

    "Given the constantly changing landscape of long-acting drug delivery, GB-102 has the potential to significantly reduce the treatment burden for patients compared to the current standard of care," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug. "The ALTISSIMO results support further exploration of enhanced formulations of GB-102 for the treatment of wet AMD."

    Although ALTISSIMO was not powered to show statistical significance, control of CST in patients treated with twice-a-year GB-102 1mg compared with baseline was similar to bi-monthly aflibercept, while BCVA trended lower in GB-102 1mg patients as compared with aflibercept. This trend in visual acuity was primarily driven by six patients: two patients whose disease was not well-controlled despite frequent anti-VEGF treatment prior to enrollment, two patients who experienced adverse events unrelated to GB-102, and two patients who experienced adverse events related to dispersion of GB-102 microparticles.

    Over the past 18 months, Graybug continued to optimize its technology platform and initiated the development of additional formulations, which have the potential to preserve the durability of GB-102 microparticles while minimizing the risk of dispersion. These new and enhanced formulations, including injectable implants, also have the potential to simplify the drug reconstitution process as well as minimize the injection technique variability. They have already been incorporated into the development programs of both GB-102 and GB-401. Graybug anticipates that its GB-401 implant program for glaucoma will enter a Phase 1 trial in the first half of 2022.

    "We are encouraged by the ALTISSIMO full-data analysis that indicates favorable safety, extended durability, and pharmacodynamics of GB-102, and are in the process of designing an additional trial in wet AMD with enhanced formulations of GB-102 while looking for a partner to fund its further clinical development," said Fred Guerard, PharmD, Chief Executive Officer, Graybug Vision. "We will pause development of GB-103 and GB-102 for diabetic macular edema while we devote our current cash to advancing GB-401 through Phase 1 clinical development. Our opportunistic in-licensing efforts will continue targeting technologies addressing high unmet medical needs in ophthalmology."

    Graybug expects to report the results from the on-going six-month extension period of ALTISSIMO in the fourth quarter of 2021.

    Conference Call and Webcast

    Graybug's management will host a webcast and conference call at 8 a.m. ET / 5 a.m. PT today, May 12, 2021, to discuss the ALTISSIMO clinical results. The live call may be accessed by dialing (844) 955-2748 (domestic) and (929) 517-0407 (international) and entering the conference ID# 5461708 or via webcast from the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations. Following the live event, a replay will be available at the same location.

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug's other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements regarding the company's clinical pipeline, its ability to identify a partner to advance the development of GB-102 for wet AMD, the timing or outcomes of its interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through preclinical or clinical development, its ability to timely secure a partner to fund further development of GB-102 on reasonable terms if at all, achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, and the timing, cost, and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2020, and the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Investor Contact



    (650) 487-2409



    Media Contact



    (404) 384-0067



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  3. REDWOOD CITY, Calif., May 05, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced it will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial on Wednesday, May 12, 2021 at 8 a.m. Eastern time (5 a.m. Pacific time).

    The event will be available live by dialing (844) 955-2748 (domestic) and (929) 517-0407 (international) and entering the conference ID# 5461708 or via webcast from the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations

    REDWOOD CITY, Calif., May 05, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced it will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial on Wednesday, May 12, 2021 at 8 a.m. Eastern time (5 a.m. Pacific time).

    The event will be available live by dialing (844) 955-2748 (domestic) and (929) 517-0407 (international) and entering the conference ID# 5461708 or via webcast from the IR Events & Presentations page of the Investors and Media section of Graybug's website at https://investors.graybug.vision/news-events/events-presentations. Following the live event, a replay will be available at the same location.

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a microparticle depot formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug is also using its proprietary technologies to develop GB-401, an injectable depot formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements regarding the results of the Phase 2b ALTISSIMO trial, the company's clinical pipeline, interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, and the timing and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading "Risk Factors" in the company's most recent annual and quarterly reports, and the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

    Investor Contact



    (650) 487-2409



    Media Contact



    (404) 384-0067





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    • Median time to first supportive therapy was 5 months for GB-102 1mg
    • 48% of patients in the GB-102 1 mg arm were rescue-free for at least 6 months
    • Control of retinal thickness was consistent across all trial arms
    • Mean best-corrected visual acuity with GB-102 1mg trended lower than aflibercept arm
    • No drug-related serious adverse events
    • Clinical monitoring is ongoing to observe durability beyond 6 months

    REDWOOD CITY, Calif., March 09, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided preliminary topline data from the 12-month treatment phase of its Phase 2b ALTISSIMO trial…

    • Median time to first supportive therapy was 5 months for GB-102 1mg

    • 48% of patients in the GB-102 1 mg arm were rescue-free for at least 6 months
    • Control of retinal thickness was consistent across all trial arms
    • Mean best-corrected visual acuity with GB-102 1mg trended lower than aflibercept arm
    • No drug-related serious adverse events
    • Clinical monitoring is ongoing to observe durability beyond 6 months

    REDWOOD CITY, Calif., March 09, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided preliminary topline data from the 12-month treatment phase of its Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug's proprietary microparticle depot formulation of sunitinib malate injected intravitreally.

    The ALTISSIMO trial is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States. The primary endpoint is median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints are pharmacodynamics measures of mean change of best-corrected visual acuity (BCVA) from baseline and mean change of central subfield thickness (CST) of the retina from baseline.

    The trial was originally designed to evaluate two separate doses of GB-102, 1mg and 2mg, injected every 6 months as compared with aflibercept injected every 2 months. Based on the results of an interim safety analysis, the 2mg dose was discontinued after the initial dose, and all patients in that arm were switched to 1mg for their second dose.

    Analysis of the ALTISSIMO 1mg arm shows the primary endpoint of median time to first supportive therapy was 5 months. Furthermore, 48% of patients did not require supportive therapy for at least 6 months, and 62% of patients for at least 4 months or more, at least once during the trial. Overall, the 1mg dose performed better than the 2mg dose.

    Overall, GB-102 1mg was well-tolerated. There were no drug-related serious adverse events, and the majority of drug-related adverse events were mild to moderate. Medication was detected in the anterior chamber in less than 10% of GB-102 1mg injections, and no adverse event required surgical intervention. There was no vision-threatening inflammation observed, and there was no increase in intraocular pressure reported.

    CST and BCVA were measured as secondary endpoints. CST in the GB-102 1mg arm was consistent with the study control arm. The mean change from baseline for BCVA for all 20 completers was approximately 9 letters lower across all time points, on average, than that observed in the study control arm.

    At the end of the treatment phase, patients were surveyed as to their satisfaction with their treatment compared to their treatment prior to entering the trial. Over 80% of responding patients who had been treated with GB-102 reported that they were equally or more satisfied with their treatment, similar to the satisfaction expressed by patients treated with aflibercept.

    ALTISSIMO is continuing through a six-month extension in which 28 of the 50 patients who completed their Month 12 visit were eligible and agreed to continue masked clinical monitoring. Patients will continue with monthly visits until the point at which they require additional supportive therapy, up to a maximum of 6 months. As of today, 22 patients have successfully completed 2 months or more of this six-month extension period without the need for further treatment.

    Graybug will determine next steps after completing the full analysis of the ALTISSIMO results, which is anticipated to occur in the second quarter.

    "We are very grateful to all patients, investigators and staff who participated in the ALTISSIMO trial, and look forward to the read-out of the extension trial data," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug.

    About Graybug

    Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company's proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug's lead product candidate, GB-102, a microparticle depot formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug is also using its proprietary technologies to develop GB-401, an injectable depot formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements regarding the company's clinical pipeline, interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, and the timing and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2020, and the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

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