SpyGlass Pharma has reported early human data on its drug-eluting intraocular lens. The first-in-human clinical trial linked the bimatoprost delivery devices to a 45% reduction in intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
California-based SpyGlass has designed its device to deliver multiple years of bimatoprost and thereby free patients from the need to administer eye drops. The device features drug-eluting pads attached to a single-piece, hydrophobic acrylic intraocular lens. SpyGlass envisages physicians implanting the device during routine cataract surgery.
In the feasibility study, investigators randomized 23 patients undergoing cataract extraction to receive one of three doses of bimatoprost. After three months, the mean reduction in pressure across all three doses was 45%. All patients had eye pressure in the normal range without additional therapy.
“Our innovative drug delivery platform is designed to enable all cataract surgeons to provide unprecedented multi-year therapy to treat glaucoma and other chronic eye conditions at the time of routine cataract surgery. The initial data are compelling and demonstrate the potential of this new treatment paradigm to significantly improve patient management without compromises,” Malik Kahook, M.D., SpyGlass co-founder, president and executive chairman, said in a statement.
No patients suffered “significant adverse events,” according to SpyGlass, and visual outcomes were “similar” to those achieved by existing, commercially available intraocular lenses.
Buoyed by the data, SpyGlass is planning to file an IND in the next six months. The goal is to start enrolling patients in the U.S. phase 1/2 clinical trial next year.