Eyenovia Concludes Type A Meeting with FDA Related to MydCombi™ NDA Resubmission
NewsNo 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
NewsNEW 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.
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Eyenovia Reports Third Quarter 2021 Financial Results
NewsEyenovia 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
NewsDiscussion 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
NewsEyenovia 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
NewsGenus 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
NewsNEW 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
NewsPrimary 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
NewsNEW 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…