SpyGlass Pharma Reports Positive Clinical Results for BIM-IOL System in Glaucoma Treatment

SpyGlass Pharma has announced positive outcomes from two clinical trials assessing the efficacy and safety of its lead product candidate, the Bimatoprost Drug Pad-Intraocular Lens (BIM-IOL) System, in patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT).

The results were presented by Malik Kahook, MD, co-founder and president of SpyGlass Pharma, at the Interventional Glaucoma Consortium (IGC) held in Salt Lake City, Utah. Data included:

       • 36-month follow-up from the first-in-human (FIH) trial

       • 3-month interim results from the ongoing phase 1/2 trial

First-in-Human Trial: 3 Years of Sustained IOP Reduction

According to Dr. Kahook, the FIH trial demonstrated that the BIM-IOL System can achieve sustained intraocular pressure (IOP) reduction, drop-free management, and excellent visual performance over a period of 36 months.

“The FIH results demonstrate that the BIM-IOL System can deliver sustained IOP reduction, drop-free outcomes, and strong visual performance for three years,” said Dr. Kahook.
“Our phase 1/2 trial aims to confirm these findings across a larger patient population and has shown similar IOP reduction and drop-free outcomes three months after implantation.”

He added that the results represent a significant milestone for both SpyGlass and glaucoma patients seeking alternatives that reduce medication burden.

Key Findings from the FIH Trial (36 Months)

       • 37% reduction in mean IOP, from 25.1 ± 2.5 mmHg (post-washout) to 15.9 ± 2.7 mmHg

       • 95% of evaluable patients were off all topical IOP-lowering medications

       • 100% of patients achieved 20/30 or better best-corrected distance visual acuity (BCDVA)

       • No product-related adverse events reported

Phase 1/2 Trial: Interim Data Supports Early Efficacy and Safety

The ongoing phase 1/2 trial is evaluating the BIM-IOL System at two dose levels, 78 mcg and 39 mcg, against a control group implanted with a standard monofocal intraocular lens (IOL) and treated with twice-daily timolol eye drops.

At the 3-month interim analysis, the BIM-IOL System demonstrated:

       • Sustained IOP reduction

       • Elimination of topical medications

       • Visual outcomes comparable to the control group

Key Results from the Phase 1/2 Trial (3 Months)

Mean IOP Reduction:

       • 37% in the 78 mcg group

       • 36% in the 39 mcg group

       • 37% in the control group at 8 AM (similar at 10 AM)

Medication Independence:

       • 98% (49/50) of patients in the 78 mcg group

       • 96% (22/23) of patients in the 39 mcg group were off all topical medications

Visual Performance:

       • All patients achieved 20/40 or better BCDVA

       • Mean BCDVA ranged from 85 to 86 letters, equivalent to approximately 20/20 vision