SpyGlass Pharma, Inc. (Nasdaq: SGP) has reported positive four-year interim results from its first-in-human trial of the Bimatoprost Drug Pad-IOL System. The data, announced from Irvine, California, indicate that the implant sustained intraocular pressure reduction in patients with mild-to-moderate open angle glaucoma or ocular hypertension who underwent cataract surgery.
In the single-center, prospective trial, 23 patients were originally assigned to three dosage groups: 75 mcg, 150 mcg, and 300 mcg. By the 48-month timepoint, 21 evaluable patients remained in the study. One patient moved outside the country and another was discontinued following a cancer diagnosis prior to the 36-month visit. The BIM-IOL System is designed to deliver bimatoprost for up to seven years, although the version currently in Phase 3 trials is engineered for three years of delivery.
The four-year data showed a 37% reduction in mean intraocular pressure across all dose groups, dropping from a baseline post-washout of 25.1 ± 2.5 mmHg to 15.9 ± 2.8 mmHg. Additionally, 86% of the evaluable patients (18 of 21) remained off all topical IOP-lowering drops, and 90% maintained best corrected distance visual acuity of at least 20/25. The company reported no product-related adverse events during this period.
Patrick Mooney, chief executive officer of SpyGlass Pharma, stated that this is the first instance where a sustained delivery implant for glaucoma has shown durable safety and efficacy over a four-year period. Mooney noted that approximately one million cataract procedures are performed annually in the United States in patients with glaucoma, representing an unmet need that the BIM-IOL System aims to address by combining cataract surgery with IOP management in a single procedure.
Paul Yoo, O.D., senior vice president of clinical development for SpyGlass Pharma, described the results as establishing a new benchmark for durable, drop-free disease control. The company plans to continue following these patients through 2029 to gather further long-term safety and efficacy evidence. SpyGlass Pharma intends to work with the U.S. Food and Drug Administration to advance the program through a 505(b)(2) New Drug Application submission.
The BIM-IOL System comprises proprietary non-bioerodible drug pads attached to an intraocular lens. Bimatoprost is a prostaglandin analog approved by the FDA for topical use in 2001. The company was founded in 2019 by Malik Y. Kahook, M.D., and Glenn Sussman, and its platform was originally developed at the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine.