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The SpyGlass IOL platform showcased a 45% drop in mean intraocular pressure at 3 months in first-in-human glaucoma trial.
New 3-month data from a first in-human trial of a breakthrough drug delivery platform suggest it lowered intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The SpyGlass platform, from SpyGlass Pharma, consisted of a single-piece, hydrophobic acrylic intraocular lens (IOL) and drug-eluting pads, implanted directly into the capsular bag during routine cataract surgery. It is designed to deliver long-period bimatoprost therapy to lower IOP in this patient population.
The new findings were presented during the Eyecelerator innovation meeting at the 2022 American Academy of Ophthalmology Annual Meeting in Chicago.
A total of 23 patients undergoing cataract surgery were randomized to receive one of three doses of bimatoprost using the SpyGlass platform. By the 3-month mark, the mean reduction in IOP across groups was 45% and all patients achieved IOP of 18mmHg or lower without needing additional therapy.
Investigators noted that no signficant adverse events were reported and visual outcomes were similar when compared to those achieved with commercially available IOLs.
In an interview with HCPLive, Robert Cionni, MD, Adjunct Associate Professor at the University of Utah and the John A. Moran Eye Center, discussed the positive findings at the 3-month mark.
"This study was designed to be a six month study, so we have three months to go," Cionni said. "And we expect that we're going to continue to see good pressure lowering for at least six months and potentially as long as three years."
It is expected that SpyGlass Pharma will file an investigational New Drug Application in the next 6 months. Pending clearance, they will begin enrollment in a Phase 1/2 clinical trial in 2023.