SpyGlass Pharma Initiates Phase 1/2 Clinical Trial of its Intraocular Drug Delivery Platform

SpyGlass Pharma announced the initiation of a phase 12 clinical trial investigating its intraocular drug delivery platform in patients with glaucoma and visually significant cataracts. The SpyGlass platform is designed to be implanted at the time of routine cataract surgery and deliver multiple years of bimatoprost to lower IOP in patients with open angle glaucoma or ocular hypertension.

“The initiation of our phase 1/2 study is an exciting and significant milestone for the company,” Malik Y. Kahook, MD, Co-Founder, Executive Chair and President of SpyGlass Pharma, said in a company news release. “Our platform has the potential to meaningfully improve care for patients living with glaucoma. We were pleased to receive clearance from the FDA to initiate our clinical trial and look forward to advancing this important study.”

The prospective, multicenter, randomized, phase 1/2 study is designed to evaluate both safety and efficacy of the SpyGlass platform with bimatoprost implanted with the SpyGlass IOL at the time of cataract surgery vs. a control group that will receive a commercially available IOL followed by topical IOP-lowering drops.

“We are enthusiastic about conducting this vital research and working with the FDA to advance our platform through clinical development,” said Patrick Mooney, CEO of SpyGlass Pharma. “Our patient-first mindset is at the core of what we do every day and keeps us inspired to drive forward a platform that has the promise of lowering IOP for glaucoma patients without the need to self-administer daily drop therapy.”

The phase 1/2 study is supported by positive data from a first-in-human feasibility study, in which patients receiving the SpyGlass IOL with bimatoprost have experienced a consistent 45% mean reduction in IOP at 9 months.