SpyGlass Pharma, Inc. announced positive 4-year first-in-human (FIH) trial results for the Bimatoprost Drug Pad-IOL System (BIM-IOL System) in patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT) undergoing routine cataract surgery. SpyGlass Pharma said in a press release that it designed the FIH trial to evaluate the safety and efficacy of the BIM-IOL System in patients for 7 years.

Interim safety and efficacy data from 21 evaluable patients at the 4-year time point showed a 37% reduction in mean intraocular pressure (IOP) across all 3 dose groups, from 25.1 ± 2.5 mmHg at baseline after washout to 15.9 ± 2.8 mmHg.

In addition, 86% (18 of 21) of patients remained off all topical IOP-lowering drops, and 90% of patients maintained ≥20/25 best-corrected distance visual acuity. No product-related adverse events were reported, the company said.

The FIH trial is a single-center, prospective trial evaluating the BIM-IOL System for the treatment of elevated IOP in patients with mild-to-moderate OAG or OHT undergoing routine cataract surgery. A total of 23 patients were sequentially assigned 1:1:1 across 3 dose groups (75 mcg, 150 mcg, and 300 mcg).

The BIM-IOL System in the FIH trial is designed to deliver bimatoprost for up to 7 years. By comparison, the BIM-IOL System being evaluated in ongoing phase 3 trials is designed to deliver bimatoprost for 3 years. At the 48-month time point, 21 evaluable patients remained. Prior to the 36-month visit, 1 patient moved outside the country, and 1 patient was discontinued after receiving a cancer diagnosis.

The company said it continues long-term follow-up of patients in both the FIH trial and the phase 1/2 trial, as well as patient enrollment in ongoing phase 3 clinical trials. GP