According to the company, its Phase I/II trial is being initiated to investigate SpyGlass platform for the long-term delivery of bimatoprost in patients with glaucoma and visually significant cataracts.
SpyGlass Pharma announced today the initiation of a Phase I/II clinical trial investigating its intraocular drug delivery platform in patients with glaucoma and visually significant cataracts.
The company noted in a news release1 its platform is designed to be implanted at the time of routine cataract surgery and deliver multiple years of bimatoprost, to lower IOP in patients diagnosed with open angle glaucoma or ocular hypertension.
Malik Y. Kahook, MD, co-founder, executive chair and president of SpyGlass Pharma, pointed out the start of the study is a key milestone for the company.
“Our platform has the potential to meaningfully improve care for patients living with glaucoma,” Kahook said in the news release. “We were pleased to receive clearance from the FDA to initiate our clinical trial and look forward to advancing this important study.”
Moreover, the company noted the prospective, multicenter, randomly assigned , Phase I/II study is designed to evaluate both safety and efficacy of the SpyGlass platform with bimatoprost implanted with the SpyGlass intraocular lens at the time of cataract surgery vs. a control group that will receive a commercially available IOL followed by topical IOP-lowering drops.1
“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.”
According to the news release, the Phase I/II 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.1