SpyGlass Pharma Announces Results from Two Clinical Trials of its BIM-IOL System for Glaucoma

SpyGlass Pharma announced positive results from two clinical trials evaluating its lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for the treatment of elevated IOP in patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT).

The results, presented by Malik Kahook, MD, co-founder and president of SpyGlass Pharma, at the Interventional Glaucoma Consortium (IGC) in Salt Lake City, Utah, included 36-month follow-up data from the first-in-human (FIH) trial and 3-month interim safety and efficacy data from the ongoing phase 1/2 trial.

Long-Term FIH Trial Results: 3 Years of Sustained IOP Reduction

Dr. Kahook reported that the FIH trial demonstrated the ability of the BIM-IOL System to provide sustained, drop-free IOP reduction and excellent visual outcomes over a 36-month period.

“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. Together, these results represent an important milestone for both SpyGlass and patients in need of disease control while removing the adherence burden.”

Key FIH Findings at 36 Months:

• 37% reduction in mean IOP across all dose groups, 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 evaluable patients achieved 20/30 or better best-corrected distance visual acuity (BCDVA)

• No product-related adverse events (AEs) were reported

Phase I/II Interim Results: Confirming Sustained Efficacy and Drop-Free Outcomes

The phase 1/2 trial evaluates the safety and efficacy of the SpyGlass BIM-IOL System delivering bimatoprost at two dose levels (78 mcg and 39 mcg), compared to a control group implanted with a standard monofocal IOL and treated with twice-daily timolol eye drops.

At the 3-month interim analysis, the BIM-IOL System achieved sustained IOP reduction, elimination of topical medications, and improved visual outcomes comparable to the control group.

Phase I/II Three-Month Results:

• Mean IOP reduction:

  • 37% in the 78 mcg group

  • 36% in the 39 mcg group

  • 37% in the control group at 8 am (similar results 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 free from all topical IOP-lowering medications

• Visual performance:

  • All patients achieved 20/40 or better BCDVA, with a mean BCDVA of 85–86 letters (~20/20 vision)