Positive Type A meeting with FDA for MydCombi NDA resubmission for mydriasis

On October 22, 2021, Eyenovia received a complete response letter (CRL) from the FDA stating that MydCombi, the company’s proprietary, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation, had been reclassified as a drug-device combination product. Following the recent Type A meeting, Eyenovia and the agency reached alignment on the path forward toward an NDA resubmission. Specifically, FDA has requested that the company conduct additional device testing related to the Optejet dispenser. Importantly, no additional clinical studies of MydCombi were requested.

About Optejet and Microdose Array Print (MAP) Therapeutics; Eyenovia's Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver approximately 8 uL of drug, consistent with the capacity of the tear film of the eye. The company estimates the volume of ophthalmic solution administered with the Optejet is less than 20% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular blink reflex.

Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% historically seen with conventional eyedroppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.