NEW YORK, March 25, 2021 (GLOBE NEWSWIRE) — 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, today announced its financial results for the fourth quarter and full year ended December 31, 2020.
Fourth Quarter 2020 and Recent Business Highlights
- U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for the Company’s pupil dilation agent MydCombi™ and subsequently notified the Company that the expected PDUFA date is October 28, 2021.
- Completed patient enrollment in the Company’s Phase 3 VISION-1 study of MicroLine for the improvement in near vision in patients with presbyopia.
- Licensed MicroPine, an investigational treatment for the reduction of pediatric myopia progression in children ages 3-12, to Bausch Health for an upfront payment of $10 million, up to $35 million in milestone payments, and royalties ranging from mid-single digit to mid-teen percentages of gross profit on sales in the U.S. and Canada.
- Established exclusive collaboration and licensing agreement with Arctic Vision to develop and commercialize MicroPine and MicroLine, a Phase 3-ready treatment for presbyopia in Greater China and South Korea, with potential licensing and development payments of up to $41.75 million, and additional royalty or supply payments.
- Closed a public offering of the Company’s common stock for net proceeds of approximately $12.5 million.