SpyGlass Pharma completed enrollment for its Phase 1/2 clinical trial evaluating its drug-eluting IOL for long-term treatment of glaucoma and ocular hypertension. The SpyGlass drug-delivery platform, designed to deliver 3 years of bimatoprost to lower IOP, can be implanted during routine cataract surgeries, the company said in a press release. 

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), the company said. 

“Completing enrollment in this study is an important milestone,” said Patrick Mooney, SpyGlass Pharma’s chief executive officer, in the 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.