Eyenovia Confirms Expanded MicroProst Phase 3 Indication to Enroll Broad Patient Population for IOP Lowering

Eyenovia confirmed a broad patient population for its phase 3 MicroProst program (microdose latanoprost with Optejet delivery) for the lowering of IOP. Following discussions with the FDA, the study population will include chronic angle closure glaucoma (CACG), as well as open angle glaucoma (OAG) and ocular hypertension (OHT) patients, representing a total addressable population of approximately 4 million in the United States. As anticipated, 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. If approved, 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,” Sean Ianchulev, MD, MPH, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “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.”

“Together, open angle glaucoma and ocular hypertension represent a larger patient population in the United States compared to chronic angle closure glaucoma. 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,” said Shan Lin, MD, Glaucoma Specialist at the Glaucoma Center of San Francisco. “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.”