Eyenovia and EVERSANA Announce Partnership to Support the Potential Launch and Commercialization of MydCombi for Mydriasis

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary Microdose Array Print (MAP) platform technology, and EVERSANA, the pioneer of next-generation commercial services to the global life sciences industry, today announced a partnership to help commercialize MydCombi in the United States, if approved.

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This announcement follows the U.S. Food and Drug Administration’s recent acceptance of Eyenovia’s New Drug Application (NDA) for MydCombi, a fixed combination mydriatic (pupil dilation) agent for potential use in the over 80 million comprehensive eye exams conducted each year in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet. The expected PDUFA date for the potential approval of MydCombi is in the fourth quarter of 2021.

If MydCombi is approved, EVERSANA will serve as Eyenovia’s exclusive distributor for all customers in the United States, responsible for accepting and managing orders, payments and shipping of MydCombi to eye care offices throughout the United States. Additionally, EVERSANA will help realize Eyenovia’s strategic commercial strategy by establishing an Eyenovia e-commerce platform to collect and analyze sales data and provide relevant analytics.

“Eyenovia is striving to make the MydCombi launch efficient and seamless for its eye care provider customers,” said Michael Rowe, Chief Operating Officer at Eyenovia. “EVERSANA has an exemplary track record for customer service and commercial excellence. Through this partnership, launch and distribution activities that would typically require an infrastructure build will be managed by EVERSANA, a strategy we anticipate will keep costs well below what is typical in ophthalmology.”

MydCombi was developed to address several challenges eye care practitioners and their patients face related to pupil dilation. The current standard of care for pupil dilation requires multiple eye drops including a topical anesthetic, given at least several minutes apart, which can take considerable time and often cause both discomfort and drug overflow. The design of eyedroppers also lends itself to the possibility of inadvertent contact with the eye itself, which may be an issue, as the same eyedropper bottle is often shared among a number of patients. In contrast, MydCombi is delivered by Eyenovia’s proprietary Optejet dispenser, designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application. The product is designed with no protruding parts, which may help prevent accidental touching of the ocular surface.