Eyenovia and Eversana announce partnership to support the launch in the US of MydCombi a treatment for Mydriasis

Eyenovia, Inc., and Eversana, the pioneer of next-generation commercial services to the global life sciences industry, announced a partnership to help commercialize MydCombi in the United States, if approved. This announcement follows the FDA'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, Eversamna 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. Mydriasis is the dilation of the pupil, usually having a non-physiological cause,or sometimes a physiological pupillary response. Non-physiological causes of mydriasis include disease, trauma, or the use of drugs. Normally, as part of the pupillary light reflex, the pupil dilates in the dark and constricts in the light to respectively improve vividity at night and to protect the retina from sunlight damage during the day. A mydriatic pupil will remain excessively large even in a bright environment. The excitation of the radial fibres of the iris which increases the pupillary aperture is referred to as a mydriasis. More generally, mydriasis also refers to the natural dilation of pupils, for instance in low light conditions or under sympathetic stimulation.