SpyGlass Pharma announced positive 4-year first-in-human (FIH) trial results for the Bimatoprost Drug Pad-IOL (BIM-IOL) System in patients with mild-to-moderate open angle glaucoma or ocular hypertension undergoing routine cataract surgery. SpyGlass Pharma designed the FIH trial to evaluate the safety and efficacy of the BIM-IOL System for 7 years.
Interim safety and efficacy data in evaluable patients (n = 21) at the 4-year timepoint demonstrated:
- 37% reduction in mean IOP across all three dose groups from 25.1 ± 2.5 mm Hg at baseline post-washout to 15.9 ± 2.8 mm Hg
- 86% (18 of 21) of patients remained off all topical IOP-lowering drops
- 90% of patients maintained ≥ 20/25 BCDVA
In addition, no product-related adverse events were reported.
