Eyenovia (NSDQ:EYEN) announced today that the FDA accepted its New Drug Aplication for its MydCombi pupil dilation agent.
MydCombi is a fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing in an effort to improve the patient experience, according to a news release.
New York-based Eyenovia’s proprietary Optejet dispenser, which ensures consistent and easy application of two mydriatic medications in a quick, touchless micro-mist form, delivers MydCombi. Optejet is designed with no protruding parts in an effort to prevent the accidental touching of the ocular surface.
Submission for the New Drug Application (NDA) came after two Phase 3 studies of MydCombi met primary endpoints and proved to be safe and effective for pharmacologic mydriasis, with 94% of treated eyes achieving 6mm or greater dilation at 35 minutes post-instillation. Fewer than 1% of patients in the studies reported adverse events including blurred vision, reduced acuity, photophobia or instillation site pain.
If approved by the FDA, MydCombi would be the first microdosed ocular therapeutic applied with a high-precision smart delivery system in the Optejet, according to Eyenovia.
“We are excited to see MydCombi, with our proprietary microdose array print technology, move closer to potential approval, with an expected PDUFA date in the fourth quarter of this year. MydCombi may address many of the current shortfalls of pupil dilation, which according to market research may be responsible for millions of people choosing not to undergo a comprehensive eye exam,” Eyenovia CEO & CMO Dr. Sean Ianchulev said in the release. “If approved, we believe MydCombi would provide patients with one of the biggest advances in clinical mydriasis in the last few decades.”