REDWOOD CITY, Calif., February 28, 2020 – Graybug Vision, Inc., a biopharmaceutical company focused on developing transformative medicines to treat diseases of the retina and optic nerve, today presented pre-clinical study results for GB-401, a novel injectable depot formulation of a proprietary beta-adrenergic antagonist prodrug, as a potential sustained-delivery treatment of up to six months for primary open angle glaucoma (POAG), at the American Glaucoma Society Annual Meeting in Washington, DC.
The study evaluated the in vitro and in vivo performance of GB-401 including pharmacokinetics, ocular safety, and intraocular pressure (IOP) lowering efficacy and showed that GB-401 achieved sustained ocular drug levels and reduced IOP in experimental animal models after a single intravitreal or subconjunctival injection. “We are encouraged by these preclinical study results and look forward to evaluating the potential of GB-401 as a new long-term treatment for patients with primary open angle glaucoma in a Phase 1/2a first-in-human trial,” said Frederic Guerard, CEO of Graybug Vision.
Primary open angle glaucoma (POAG) is the most common type of glaucoma, a progressive degeneration of the optic nerve and a leading cause of irreversible vision loss, with more than three million people affected in the United States and over 70 million worldwide. Reducing IOP is the only proven treatment to prevent the progression of vision loss associated with POAG. While approved topical eye drops that can lower IOP exist, their effect is often limited due to poor patient compliance and low drug bioavailability/residence time on the corneal surface. Studies show that significant numbers of glaucoma patients stop taking their medications due to factors including disability, cognitive decline, lack of disease awareness and cost.
GB-401 achieved high drug loading and encapsulation efficiency of a proprietary beta-adrenergic antagonist prodrug and demonstrated tunable sustained drug release kinetics for approximately 6 months in vitro. Our ongoing pharmacokinetic study revealed sustained therapeutic drug levels in the eye from day one to over three months. A single injection of GB-401 also led to a sustained reduction of IOP in an experimental ocular hypertension animal model, with no signs of ocular toxicity.
About Graybug Vision
Graybug Vision is a clinical stage biopharmaceutical company focused on developing transformative medicines to treat diseases of the retina and optic nerve. The company’s proprietary ocular delivery technologies are designed to maintain potent and effective drug levels in ocular tissue for up to 12 months and potentially longer, improving patient compliance, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug’s lead product candidate, GB-102, a microparticle depot formulation of sunitinib malate, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration, with a six-month dosing regimen. This approach is differentiated from the current standard of care, which requires more frequent dosing and only targets one pathway. Graybug is also using its proprietary technologies to develop GB-401, an injectable depot formulation of a beta-adrenergic prodrug, for primary open angle glaucoma, with a dosing regimen of up to six months, and GB-103, a longer-acting version of GB-102, designed to deliver therapeutic drug levels to the retinal tissue for 12 months with a single injection. Founded in 2011 as a spin-out of the Wilmer Eye Institute of the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.com.