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 worldwide. Glaucoma progresses slowly and with 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.

Glaucoma and the issue of noncompliance
We are developing GB-401 for the reduction of elevated intraocular pressure, or IOP, in patients with primary open angle glaucoma, or POAG. About 60 million people are affected by POAG globally. More than three million Americans are living with glaucoma, 2.7 million of whom—aged 40 and older—are affected by POAG.

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. These medications must be administered up to four times per day, and it is estimated that approximately 30% of patients often require more than one medication.

Poor adherence to glaucoma medication regimens has been documented in numerous independent studies, which often place the incidence of patient noncompliance up to or above 50%, particularly in patients on two or more prescription eye drops. It is estimated that approximately 60-80% of patients stop taking their glaucoma medications in the first year post-diagnosis due to disability, including cognitive decline, lack of disease awareness and/or cost. As a result, despite the availability of medication to treat glaucoma, progressive visual loss and blindness still occur.

GB-401: Our approach
GB-401 is a depot formulation of a proprietary inactive pro-drug ester of a beta-adrenergic receptor inhibitor, injected intravitreally as infrequently as every six months to reduce IOP. We designed GB-401 with the goal of improving glaucoma patient outcomes through increased compliance and a favorable tolerability and safety profile. For patients, our goal is to eliminate the need for daily eye drops required to manage elevated IOP. For physicians, our goal is to design a long-acting IOP-lowering treatment that can be administered in the office through IVT injections, ensuring patient compliance for up to six months. We aim to deliver sustained IOP-reduction similar to standard of care, without systemic exposure.

We expect to submit an investigational new drug application, or IND, for GB-401 in the second quarter of 2020 and to initiate a dose-escalating Phase 1/2a trial of GB-401 in patients with POAG in the second half of 2020.