For people with chronic diseases of the retina and the optic nerve, we develop medicines that make healthy vision more accessible and manageable, promoting better compliance and visual outcomes.
Glaucoma is an optic neuropathy that is characterized by the progressive degeneration of the optic nerve, leading to visual impairment. It is a leading cause of irreversible vision loss affecting approximately 76 million people worldwide in 2020.
POAG is the most common type of glaucoma, in which the eye pressure increases because the fluid cannot drain properly from the eye. Though the specific mechanism of neuronal damage in POAG has not been fully identified, progressive visual field loss is often associated with intraocular pressure (IOP).
In the healthy eye, the ciliary body produces fluid that circulates through the pupil and drains in the corner, or the angle, of the eye where the cornea and iris meet.
In POAG, pressure in the eye can increase if there is increased fluid production and/or decreased drainage in the angle leading to elevated IOP.
Chronically elevated IOP can lead to neuronal degeneration and retinal ganglion cell death with resulting disruption of the visual pathway.
Currently approved topical eye drops can lower IOP by either decreasing aqueous production and/or enhancing aqueous drainage when used as directed by a physician.
Various drug classes for glaucoma therapy include prostaglandin analogs, or PGAs, betablockers, alpha-adrenergic agonists, carbonic anhydrase inhibitors, rho-kinase inhibitors, combination drugs and others. These medications must be administered up to four times per day.
A number of procedures have been developed to treat patients whose disease has significantly progressed. These include laser or surgical treatments reserved for patients for whom other measures have failed.
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.
Our goal is to provide sustained reduction of elevated IOP associated with POAG to increase compliance for patients and improve the medical management of glaucoma.
For patients, we aim to eliminate the need for daily eye drops required to manage elevated IOP.
For physicians, we aim to design a long-acting IOP-lowering treatment that can be administered in the office through intravitreal injections, ensuring patient compliance for up to six months.
GB-401 has the potential to reduce elevated IOP for at least six months
GB-401 is an inactive new chemical entity (NCE) prodrug of a beta-adrenergic receptor inhibitor, or beta-blocker, formulated with our proprietary microparticle technologies for controlled release and is designed to be administered intravitreally once every six months. Upon exposure to water under physiologic conditions, the prodrug is released from the polymer 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.
GB-401 is designed to provide controlled drug release with minimal burst effects that can result in potential systemic exposure of the beta-blocker. The figure below illustrates sustained in vitro drug release from GB-401 for 180 days at 37° C without a burst effect.
We believe that GB-401 has the potential to provide sustained reduction in IOP for at least six months, thus eliminating the need for frequent patient-instilled eye drops.