SpyGlass Pharma, Inc. (Nasdaq: SGP) announced on October 19, 2026, the release of positive interim data from the first-in-human (FIH) trial of its Bimatoprost Drug Pad-IOL System (BIM-IOL System). The filing details results from a single-center, prospective study evaluating the device in patients with mild-to-moderate open angle glaucoma (OAG) or ocular hypertension (OHT) undergoing cataract surgery.
The trial enrolled 23 patients, who were sequentially assigned in a 1:1:1 ratio across three dosage groups (75 mcg, 150 mcg, and 300 mcg). At the 48-month (4-year) timepoint, 21 patients remained evaluable for the analysis. The data indicates a 37% reduction in mean intraocular pressure (IOP) across all dose groups. Baseline IOP post-washout was recorded at 25.1 ± 2.5 mmHg, dropping to 15.9 ± 2.8 mmHg at the 4-year mark.
Efficacy outcomes showed that 86% of patients (18 of 21) remained off all topical IOP-lowering drops. Additionally, 90% of patients maintained a best corrected distance visual acuity (BCDVA) of 20/25 or better. The company reported no product-related adverse events during the 4-year follow-up.
The BIM-IOL System is designed to deliver bimatoprost for up to seven years. SpyGlass Pharma noted that this is the first sustained drug delivery implant for glaucoma therapy to demonstrate durable safety and efficacy results for four years. The company plans to work with the FDA to advance the program toward a 505(b)(2) New Drug Application (NDA) submission and potential commercial approval.
