Glaucoma is an optic neuropathy that is characterized by the progressive degeneration of the optic nerve, leading to visual impairment.
Primary Open Angle Glaucoma
About Primary Open
Angle Glaucoma (POAG)
Approximately 50% of patients stop taking their glaucoma medications
within the first six months of treatment initiation due to various reasons, including forgetfulness, lack of disease awareness and/or cost.
About 30% of patients often require more than one medication.
Poor adherence to glaucoma medication regimens has been documented in numerous independent studies, particularly in patients on two or more prescription eye drops.
15-20% of glaucoma patients progress to blindness within 15-20 years of diagnosis.
As glaucoma progresses slowly and causes few symptoms, patients often do not adhere to their medication regimens as prescribed until the disease has progressed to the point of significant vision loss. As a result, despite the availability of medication to treat glaucoma, progressive visual loss and blindness still often occur.
GB-401 is a first-in-class implant formulation containing a novel prodrug of timolol injected intravitreally with a proprietary applicator, targeting twice-yearly treatment.
GB-401 is formulated with our biodegradable polymer implant technology for controlled release of the beta blocker and is designed to be administered intravitreally once every six months. The twice per year regimen will increase patient compliance, has better tolerability and likely results in better treatment outcomes.
The prodrug in the GB-401 is a proprietary new chemical entity. Upon exposure to water under physiological conditions, the prodrug is released from the implant and is converted into the active beta-blocker by hydrolysis.
The polymer biodegrades into normal metabolic by-products of lactic and glycolic acid and is naturally cleared from the eye.
Our implant formulation of GB-401 is designed to provide controlled drug release within the eye that minimizes the risk for systemic exposure of the beta-blocker. The figure on the right illustrates sustained in vitro drug release from the GB-401 implant for 120 days at 37° C.
- In a rat model for ocular hypertension, a single intravitreal injection of the GB-401 pro-drug formulation led to sustained IOP reduction that appeared to be at least as potent as twice daily administration of topical beta-blocker 0.5% ophthalmic solution for 28 days
Single injection intravitreal route and comparator topical eye drop (rat OHT model)
- In rabbit eyes, we observed gradual biodegradation of the GB-401 implant over a period of 24 weeks, suggesting a potential durability of six months in human eyes
from different animals at different timepoints.