Eyenovia Concludes Type A Meeting with FDA Related to MydCombi™ NDA Resubmission

No additional clinical work required; NDA resubmission anticipated in Q3 2022 NEW YORK, Feb. 08, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose…

Eyenovia Announces Changes to the Board of Directors

NEW YORK, Feb. 07, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, today announced changes to its Board of Directors. …

Eyenovia Reports Third Quarter 2021 Financial Results

Eyenovia Reports Third Quarter 2021 Financial Results On track with VISION-2 phase 3 presbyopia trial and expedited resubmission of MydCombi™ New Drug Application as a drug/device combination in early 2022 Current cash resources anticipated…

Eyenovia to Participate in Myopia Panel Discussion at the Eyecelerator @AAO 2021 Meeting

Discussion to Include Future Potential Treatment Options, Including MicroPine (atropine ophthalmic spray), for reduction of myopia progression in pediatrics NEW YORK—November 8, 2021—Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic…

Eyenovia Announces First Patient Enrolled in Phase 3 VISION-2 Trial of MicroLine for Presbyopia

Eyenovia Announces First Patient Enrolled in Phase 3 VISION-2 Trial of MicroLine for Presbyopia Vision-2 follows successful Vision-1 trial with expected top-line results in Q2 2022  Presbyopia represents a multi-billion-dollar market…

Eyenovia Announces Reclassification of MydCombi™ as Drug-Device Combination Product by FDA

Genus Medical Technologies, LLC v. FDA legal case leads to agency-wide review of all drugs that are in delivery systems, including eye dropper bottles  Company received Complete Response Letter with additional requests and is preparing necessary…

Eyenovia highlights Recent Progress in Three Phase 3 Programs, NDA Review Progress and Licensing Agreements Totaling up to $100 Million in Potential Pre-Commercial Revenue

NEW YORK, June 15, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today provided a corporate update on its…

Eyenovia Announces Positive Topline Results from VISION-1 Phase 3 Clinical Study of MicroLine for the Treatment of Presbyopia

Primary endpoint was achieved with well-tolerated micro-array print (MAP™) safety profile Upcoming key 12 month milestones include Mydcombi PDUFA; Vision 2 Phase 3 trial results and completion of enrollment for CHAPERONE Phase 3 trial NEW…

Eyenovia Announces New $25 Million Credit Facility with Silicon Valley Bank

NEW YORK, May 10, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the company has entered…