■ Eyenovia, an ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print targeted delivery technology, has confirmed a broad patient population for its phase 3 MicroProst program. MicroProst delivers microdose latanoprost with Eyenovia's Optejet technology.

Eyenovia asserts that high-precision microdosing can combat overdosing issues by delivering a targeted physiologic dose of 6-8 μL by uniformly coating the corneal surface rather than the conjunctiva to reduce collateral tissue exposure and focusing on the cornea where 80% of intraocular drug penetration occurs. Eyenovia says microdosing reduces 75% to 80% of the drug exposure to minimize toxicity, leading to an efficient and gentler treatment.

Following discussions with the FDA, the study population will include chronic angle closure glaucoma, open-angle glaucoma, and ocular hypertension 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,” said Sean Ianchulev, MD, CEO and CMO of Eyenovia, in a 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 vs latanoprost administered in drop form.”

“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 3 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, microdose delivery,” said Shan Lin, MD, glaucoma specialist at the Glaucoma Center of San Francisco, in a news release. “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.”