SpyGlass Pharma Reports Four-Year Data for Bimatoprost Drug Pad-IOL System
Irvine, California-based SpyGlass Pharma announced four-year interim results from its first-in-human clinical trial evaluating the Bimatoprost Drug Pad-IOL System in patients with mild-to-moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery, kr.investing.com reported. The study enrolled 23 patients across three dose cohorts of 75mcg, 150mcg, and 150mcg—wait, 300mcg. By the four-year mark, two patients left the study—one moved abroad and another stopped after a cancer diagnosis—leaving 21 patients available for evaluation, according to the report.
Intraocular Pressure Drops Across All Doses Without Eye Drops
Combined data across all dose groups showed average intraocular pressure dropped 37 percent, moving from a baseline of 25.1 ± 2.5mmHg measured after stopping previous medications down to 15.9 ± 2.8mmHg, kr.investing.com reported. Eighty-six percent of the evaluated patients—18 out of 21—did not use any pressure-lowering eye drops at all during the four-year check, and 90 percent maintained a corrected distance visual acuity of 20/25 or better, the company stated. No product-related adverse events turned up in the data.
Chief Executive Highlights Four-Year Sustained Safety and Efficacy
Patrick Mooney, chief executive officer of SpyGlass Pharma, stated that this marks the first time a sustained-release drug implant for glaucoma has demonstrated safety and efficacy maintained across a four-year period, kr.investing.com reported. The BIM-IOL System attaches a drug pad directly to an intraocular lens inserted during standard cataract surgery. While the first-in-human trial evaluated a product designed to release medication for up to seven years, products currently under evaluation in ongoing Phase 3 trials are built to release bimatoprost for three years.
The single-center prospective first-in-human trial is designed to track patients through 2029, kr.investing.com reported. SpyGlass Pharma intends to work alongside the U.S. Food and Drug Administration to pursue a new drug application via the 505(b)(2) regulatory pathway. Bimatoprost itself is a prostaglandin analogue originally approved by the FDA as an eye drop in 2001 to reduce high intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Frequently Asked Questions About the Bimatoprost Drug Pad-IOL System
What is the Bimatoprost Drug Pad-IOL System?
The system consists of a drug-eluting pad attached to a standard intraocular lens that surgeons implant during routine cataract surgery. It is designed to continuously release bimatoprost to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
How long is the medication designed to last in patients?
The device evaluated in the four-year interim analysis was designed to release medication for up to seven years. Meanwhile, the version currently tested in ongoing Phase 3 clinical trials is engineered to provide a three-year release duration.
What regulatory pathway is SpyGlass Pharma pursuing with the FDA?
SpyGlass Pharma plans to work with the U.S. Food and Drug Administration to pursue its new drug application through the 505(b)(2) regulatory pathway.