Eyenovia has its date with the FDA. Fourteen months after being hit with a complete response letter, the eye disease specialist has secured a May 8 date for a decision on its MydCombi ophthalmic spray.
The FDA rocked Eyenovia in October 2021, when, following a legal case that led to the reclassification of eyecups, eye droppers and ophthalmic dispensers, the agency issued a complete response letter about a filing for approval of MydCombi, an in-office pupil dilation product. The FDA reclassified MydCombi as a drug-device combination product and told Eyenovia it would need additional documents for approval.
Now, Eyenovia has returned with the additional documents and, with the FDA accepting its new drug application for review, secured a PDUFA date for MydCombi. The FDA told Eyenovia it has no plans to hold an advisory committee meeting to discuss the application.
If approved, MydCombi will become the first commercial project to feature Eyenovia’s Optejet microdose formulation and drug delivery device. The platform leverages piezo-printing, a technology used in inkjet printers, to deliver 6 to 8 μL of drug. The volume is consistent with the capacity of the tear film of the eye. Compared to standard eye droppers, Optejet could cut overdosing and exposure to preservatives.
With MydCombi, Eyenovia is using the technology to deliver tropicamide, an established medication for pupil dilation, and phenylephrine, a decongestant that also dilates the pupil. Researchers have shown that the combination is more effective than single-agent tropicamide.
In a statement, Eyenovia CEO Michael Rowe put the attempt to win approval of MydCombi in a broader context, noting that a positive FDA ruling “could bode well not only for our other internal development programs for presbyopia and progressive myopia but our ongoing partnering discussions as well.”