SpyGlass Pharma has completed enrollment for its phase 1/2 clinical trial evaluating its drug-eluting intraocular lens (IOL) for long-term treatment of glaucoma and ocular hypertension. The SpyGlass drug-delivery platform, designed to deliver 3 years of bimatoprost to lower intraocular pressure (IOP), can be implanted during routine cataract surgeries.

Over 200 patients with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery are enrolled in the Tigris trial (NCT06120842), a randomized study that will compare the Spyglass IOL delivering either a high or low dose of bimatoprost to patients treated with timolol maleate ophthalmic solution, 0.5%. The primary outcome is mean IOP reduction from baseline (mmHg).

“Completing enrollment in this study is an important milestone,” said Patrick Mooney, SpyGlass Pharma’s chief executive officer, in a press release. “We look forward to continued engagement with the FDA as we advance our platform toward 2 large phase 3 trials.”

Results from this trial and from earlier studies will inform next steps as SpyGlass seeks regulatory approval, Mooney said. SpyGlass Pharma recently reported 18-month data from its first-in-human study, which showed that patients implanted with the SpyGlass IOL showed a mean 43.7% reduction in IOP at 18 months, compared to baseline.