Eyenovia (NASDAQ:EYEN) is expanding the patient population for its Phase 3 MicroProst program for the lowering of intraocular pressure (IOP).
Following discussions with the FDA, the study population will include patients with chronic angle closure glaucoma, as well as open angle glaucoma and ocular hypertension patients, representing a total addressable population of about four million people in the U.S.
The Phase 3 program will be optimized to consist of a single MicroProst Phase 3 trial and supplemented with existing data on latanoprost for IOP lowering.
“We believe that our MicroProst study will include one of the broadest patient populations in glaucoma drug development to date,” Dr. Sean Ianchulev, CEO and CMO, said in a statement.
If approved, he said MicroProst could have one of the widest indications of commercially available IOP-lowering therapies, as well as represent the first FDA-approved drug specifically indicated for chronic angle closure glaucoma.
“Based on the results of our earlier Phase 2 trial for IOP lowering, we believe that MicroProst may achieve similar clinical efficacy with improved tolerability versus latanoprost administered in drop form, which can overdose the eye with potentially harmful preservatives and active ingredient,” he added.
Dr. Shan Lin, a glaucoma specialist at the Glaucoma Center of San Francisco, said that having an FDA-approved drug with all three conditions specified in the label means that patients who are currently prescribed or are candidates for prostaglandin therapy may have the option for next-generation, smart, micro-dose delivery.
“MicroProst may open up possibilities for patients who cannot use current eyedropper treatments due to intolerance to high-volume drug and preservative, inability to correctly instill eye drops, or poor compliance,” he added.
