SpyGlass Pharma reports 4-year glaucoma implant trial data

SpyGlass Pharma, Inc. (Nasdaq: SGP) announced interim 4-year results from its first-in-human trial of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), a sustained drug delivery implant designed for patients with mild-to-moderate open angle glaucoma or ocular hypertension undergoing cataract surgery.

Data from 21 evaluable patients showed a 37% reduction in mean intraocular pressure (IOP), falling from 25.1 ± 2.5 mmHg at baseline to 15.9 ± 2.8 mmHg. In addition, 86% of patients remained off all topical IOP-lowering drops, and 90% maintained best corrected distance visual acuity of 20/25 or better. No product-related adverse events were reported.

The trial originally enrolled 23 patients across three dosage groups of 75 mcg, 150 mcg, and 300 mcg. Two patients left the study before the 36-month visit — one relocated outside the country and one was discontinued following a cancer diagnosis.

Patrick Mooney, chief executive officer of SpyGlass Pharma, said in a statement that this is "the first time a sustained drug delivery implant for glaucoma therapy has demonstrated durable safety and efficacy results for four years."

The BIM-IOL System delivers bimatoprost, a prostaglandin analog approved by the U.S. Food and Drug Administration in 2001 for topical use, through non-bioerodible drug pads attached to an intraocular lens. The version used in ongoing Phase 3 trials is designed to deliver the drug for up to three years, while the FIH trial version targets up to seven years of delivery.

SpyGlass Pharma said it plans to continue following patients in the first-in-human trial through 2029 and is enrolling patients in Phase 3 trials. The company intends to pursue a 505(b)(2) New Drug Application submission with the FDA. The trial is being conducted at a single center on a prospective basis.

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