GRAY Graybug Vision Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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GB-102 (ALTISSIMO)
Wet age-related macular degeneration
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Phase 2b
Phase 2b
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
GB-102
Wet age-related macular degeneration (AMD)
|
Phase 3
Phase 3
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Phase 3 trials to be initiated 2H 2021.
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|
GB-102
Diabetic macular edema (DME)
|
Phase 2b
Phase 2b
|
Phase 2b trial to be initiated 2H 2021.
|
Latest News
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REDWOOD CITY, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on Wednesday, February 24, 2021 at 3:40 p.m. ET / 12:40 p.m. PT.
A live webcast of the fireside chat will be available on 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 webcast, a replay will be available at the same location for 14 days.
About Graybug Vision
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.
Investor Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067
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REDWOOD CITY, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the appointment of Bettina Maunz as Chief People Officer. In addition to building and leading the human resources function for Graybug Vision, Ms. Maunz will serve as Head of Communications and be a member of the company's executive team.
"We are delighted for Bettina to join Graybug as Chief People Officer. Her leadership, culture and communications experience will be important assets to our team," said Frederic Guerard, PharmD, Chief Executive Officer of Graybug Vision. "Her passion for building high-performing teams and driving employee engagement will be a strong contributor to our future success."
"I am excited to be joining Graybug as its first Chief People Officer," stated Bettina Maunz. "I believe the company is at an inflection point and I look forward to partnering with the executive team in shaping Graybug's culture as well as attracting and retaining the right talent to fully leverage Graybug's potential."
Bettina has served as a consultant to Graybug since August 2019 and played an integral role in the planning and successful execution of the company's IPO in September 2020. Prior to Graybug, Bettina held the position of VP, Group Head of Enterprise Communications at Novartis, where she led the development and implementation of the enterprise communications strategy with a focus on driving company-wide culture change in partnership with the executive team and human resources department. Prior to that, Bettina served as VP, Global Head of Communications at Alcon and was President of the Alcon Foundation. During her tenure, she established the Global Communications function, played a key role in the company's culture and business transformation, as well as defined and executed Alcon's corporate social responsibility strategy partnering with leading non-profit organizations to enhance access to quality eye care in developing markets as well as local communities. Bettina also served in leadership positions at CIBA Vision, Novartis Pharma and Serono International earlier in her career.
About Graybug Vision
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.
Investor Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067 -
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REDWOOD CITY, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (NASDAQ:GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the last patient visit in its GB-102 Phase 2b ALTISSIMO core trial (the 12-month treatment phase) in wet age-related macular degeneration (wet AMD). ALTISSIMO 12-month topline data are expected to be announced in the second quarter of 2021, with full results to be presented at a medical conference later in the year.
Of the 56 patients enrolled in ALTISSIMO, 50 patients completed the 12-month treatment phase, while the remaining six patients withdrew for reasons unrelated to their treatment. Furthermore, 58 percent of patients who completed their Month 12 visit were eligible and agreed to continue clinical monitoring in a six-month extension of the trial. The goal of this six-month extension period is to observe further durability of GB-102 in wet AMD patients.
"We are pleased with the completion of treatment in ALTISSIMO which is expected to provide important data regarding the duration of treatment, safety and tolerability of GB-102 in wet AMD," said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug Vision. "Wet AMD is a leading cause of vision loss among the elderly with outcomes adversely affected by the high treatment burden of approved medications which need to be injected up to 12 times per year. The findings of this trial, designed to measure the durability of a twice-per-year dosing, may potentially demonstrate the need for fewer treatments per year, and we look forward to sharing the topline results in the second quarter of 2021."
Graybug's lead product candidate, GB-102, is a proprietary microparticle depot formulation of the pan-vascular endothelial growth factor (pan-VEGF) inhibitor, sunitinib malate, designed to be administered intravitreally twice per year. GB-102 seeks to reduce the need for frequent intravitreal injections by expanding treatment duration to six months, and potentially longer, thus reducing the burden of current anti-VEGF treatments which require up to 12 injections per year.
About GB-102 Phase 2b Clinical Trial in Wet AMD (ALTISSIMO)
ALTISSIMO comprises a 12-month, multicenter, prospective, masked, randomized trial comparing GB-102 administered every six months to aflibercept administered every two months in patients with anti-VEGF-responsive wet AMD, followed by an additional six-month observational period. The objective of the ALTISSIMO Phase 2b core trial is to assess the safety, tolerability, and pharmacodynamic profile of GB-102. The findings will inform the design of Graybug's pivotal Phase 3 clinical trial program in wet AMD expected to initiate in the second half of 2021.
About Wet AMD
Wet AMD is one of the most common retinal diseases, leading to vision decline caused by excess VEGF. VEGF is a protein produced by cells that stimulates the formation of abnormal new blood vessels behind the retina, called choroidal neovascularization. The leakage of fluid and protein from the vessels causes retinal degeneration and leads to severe and rapid loss of vision. Early intervention is essential to treat wet AMD. The prevalence of wet AMD in the United States is estimated at 1.5 million people and approximately 25 million people are affected by wet AMD worldwide.
About Graybug Vision
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, 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, including the completion of the ALTISSIMO trial, 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 quarterly report on Form 10-Q for the three months ended September 30, 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
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067 -
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- Proceeds to fund development of novel and best-in-class therapeutics for eye diseases
- Charles Semba, MD, joins the company to serve as Chief Medical Officer
SHANGHAI, Nov. 27, 2020 /PRNewswire/ -- Eluminex Biosciences Limited (Eluminex), an ophthalmic biotechnology company committed to the discovery and development of first-in-class and/or best-in-class therapies, today announced the completion of a $50 million (USD) Series A Financing co-led by Lilly Asia Ventures, GL Ventures (venture capital arm of Hillhouse Capital), and Quan Capital. The Eluminex headquarters and research and development center are located in Suzhou Industrial Park; the business center is based in Shanghai, and future plans include establishing a global clinical and registration center in the San Francisco Bay Area.
"We greatly appreciate the profound level of support and trust from three global investors," said Jinzhong Zhang, PhD, Co-Founder, Chairman, and Chief Executive Officer. "With these proceeds, our goal is to build an innovative pipeline addressing critical unmet medical needs in vision-threatening diseases for patients worldwide. Additionally, we are pleased to have three world-renowned professors of ophthalmology as members of our Scientific Advisory Board: Quan Dong Nguyen, MD, MSc (Stanford University), Zuguo Liu, MD, PhD (Xiamen University), and Xiaodong Sun, MD, PhD (Shanghai Jiao Tong University). We are grateful for their significant contributions in helping us develop our pipeline programs."
The company also announced that Charles Semba, MD, has joined Eluminex as Chief Medical Officer (CMO). Dr. Semba is an internationally recognized leader in ophthalmic drug development. He has served as CMO in three prior ophthalmic companies: 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).
Regarding the success of this financing, all parties have expressed their confidence and expectations for the new company. "Closing Series A financing is indeed a major milestone. The leadership at Eluminex should be congratulated for this impressive achievement amidst current global events," commented Dr. Nguyen, Professor of Ophthalmology at the Byers Eye Institute, Stanford University. "Such financial success and security demonstrate the trusts that the company has earned from the investment community in Eluminex's research and development therapeutic plans to preserve and enhance vision for patients with devastating ocular diseases worldwide."
"Driven by an aging population and overuse of eyes in various ages, the ophthalmic market is seeing huge unmet needs for new products. The team's solid track record and rich experience in ophthalmic drug development enables the company to develop innovative therapies not only for China but also for the global market. We are thrilled and honored to join hands with this seasoned team and partner with the reputable investors from the very beginning," said Stephen Lin, Partner at Lilly Asia Ventures.
"The founding team of Eluminex Biosciences has rich experience in drug development and innovation with great potential in the future. Hillhouse will help Eluminex continue to innovate, research and develop leading ophthalmic disease treatment drugs, meeting the needs of a large number of patients, and continue to create social well-being," said Michael Yi, Partner and Co-Chief Investment Officer of Hillhouse Capital Group.
"Quan Capital is committed to foster innovation and bring new solutions to patients with great unmet needs. We are pleased to co-lead the Series A round of Eluminex and are truly impressed by the stellar management team," said Marietta Wu, Managing Director of Quan Capital. "We believe this team of seasoned industry veterans both globally and in China will build a leader in ophthalmology with accelerated development of novel therapeutics. Quan looks forward to working closely with the team and contributing our local resources and global networks."
About Eluminex Biosciences
Eluminex was established in February 2020 with the commitment to leading the development of novel therapeutics for the benefit of patients with vision-threatening eye diseases worldwide. Co-Founders, Dr. Jinzhong Zhang and Dr. Zhenze John Hu, have assembled a top tier management team with significant ophthalmic drug development experience, aiming to build a robust and sustainable innovative ophthalmic pipeline to tackle the unmet clinical needs. For detailed information contact Zhenze John Hu at [email protected]
About Lilly Ventures Asia
Lilly Asia Ventures (LAV) is a leading biomedical venture capital firm founded in 2008, with offices in Shanghai, Hong Kong, and Menlo Park. LAV's vision is to become the trusted partner for exceptional entrepreneurs seeking smart capital and to build great companies developing breakthrough products that can treat diseases and improve human health. For more information, visit www.lillyasiaventures.com.
About GL Ventures
GL Ventures focuses on early-stage innovative companies in healthcare, software services, consumer Internet, emerging consumer brands and services. The GL Ventures team is passionate about partnering with visionary entrepreneurs to create industry leaders that stand the test of time. GL Ventures is the early stage affiliate of Hillhouse Capital, and we have been investing with innovators across the world since 2005. We were one of the earliest investors into some of the largest global companies today, including BeiGene, Zoom, Meituan, JD, Woowa Brothers and many more.
About Quan Capital
Quan Capital (Quan) is a life sciences venture capital firm with strong China expertise and global capabilities. Quan discovers, incubates, and grows next-generation life science companies in early and growth stage, worldwide. Their portfolio companies pioneer differentiated therapies and enabling technologies to address major human diseases with high unmet medical needs. With offices in Shanghai, Palo Alto and Boston, Quan's investment professionals combine their strong expertise in both science and business with their diverse experiences in global drug development and healthcare investments, and leverage their broad network worldwide to help maximize the company's value across geographies and development stages. For more information, visit www.quancapital.com.
View original content:http://www.prnewswire.com/news-releases/eluminex-biosciences-an-ophthalmology-focused-biotechnology-company-announces-closing-of-50-million-series-a-financing-301181102.htmlSOURCE Eluminex Biosciences
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REDWOOD CITY, Calif., Nov. 16, 2020 (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 that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a fireside chat in advance of the virtual Piper Sandler Healthcare Conference, being held December 1-3, 2020.
A recording of the fireside chat will be accessible beginning November 23, 2020 by visiting IR Events & Presentations in the Investors and Media section of the company's website at https://investors.graybug.vision/news-events/events-presentations. The recording will be available on the Graybug website for 14 days following the conference.
About Graybug Vision
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.
Investor Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067
