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News Releases

News Releases

12/06/24

NEW YORK , Dec. 06, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”),  an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today announced that it
11/25/24

NEW YORK , Nov. 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today announced that it
11/22/24

Avenue Capital agrees to Company’s deferral of principal and interest payments on its outstanding debt until the end of February 2025 Eyenovia continues to evaluate a broad range of strategic alternatives to maximize stakeholder value NEW YORK , Nov. 22, 2024 (GLOBE NEWSWIRE) -- Eyenovia ,
11/15/24

A review of study data by an independent Data Review Committee found that CHAPERONE is not meeting its primary three-year efficacy endpoint Company to discontinue study, review full data set, and evaluate next steps for the program NEW YORK , Nov. 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia ,
11/12/24

Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for interim analysis this quarter Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device Announced the U.S.
11/07/24

Company to host an investor conference call and webcast at 4:30pm EDT NEW YORK , Nov. 07, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication
10/23/24

Publication in the Journal of Ocular Pharmacology and Therapeutics highlights the ability of the Optejet to achieve a therapeutic dose of medication with far less exposure to harmful preservatives Additional presentation at the American Academy of Optometry summarizes a Phase 4 study of Mydcombi
10/16/24

Presentation details efficacy and tolerability results from the successful Phase 3 program that led to FDA approval of clobetasol propionate suspension 0.05% for pain and inflammation following ocular surgery NEW YORK , Oct. 16, 2024 (GLOBE NEWSWIRE) -- Eyenovia , Inc. (NASDAQ: EYEN), an ophthalmic
10/01/24

The Gen-2 Optejet is designed for an optimized user experience while ensuring extended patent protection for products using the platform through 2041 NEW YORK , Oct. 01, 2024 (GLOBE NEWSWIRE) -- Eyenovia , Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced that the Company has
09/27/24

NEW YORK , Sept. 27, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”), an ophthalmic technology company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced it has entered into a
09/26/24

New market research shows strong interest from ophthalmic surgeons following their review of Clobetasol’s prescribing information NEW YORK , Sept. 26, 2024 (GLOBE NEWSWIRE) -- Eyenovia , Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced the U.S.
09/05/24

Eyenovia is planning for a U.S. launch for Clobetasol in late September 2024 NEW YORK , Sept. 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric
09/03/24

Current CFO, John Gandolfo, to remain with the Company through November as part of planned retirement transition NEW YORK , Sept. 03, 2024 (GLOBE NEWSWIRE) -- Eyenovia , Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric
08/23/24

NEW YORK , Aug. 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (“Eyenovia” or the “Company”) (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced today the closing of its public offering of 12,850,000 shares of common stock at a price per share of $0.40 (the "Offering").
08/21/24

NEW YORK , Aug. 21, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (“Eyenovia” or the “Company”) (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced today that it has agreed to sell 12,850,000 shares of common stock at a price per share of $0.40 (the "Offering").
08/20/24

NEW YORK , Aug. 20, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (“Eyenovia” or the “Company”) (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced today that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof) in a best efforts offering.
08/13/24

NEW YORK , Aug. 13, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for postsurgical
08/12/24

Following FDA consultation, announced plans for validation of the Gen-2 Optejet ® device and 2025 regulatory submission with Mydcombi™ as lead product Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4 Commenced sales
08/08/24

Company to host an investor conference call and webcast at 4:30pm EDT NEW YORK , Aug. 08, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that the Company will
08/07/24

Product-candidate would incorporate new steroid with the Optejet® for the millions of dry eye patients who experience periodic flare-ups NEW YORK , Aug. 07, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage
07/30/24

The U.S. addressable market for Dry Eye Disease is valued at over $3 billion by independent sources NEW YORK , July 30, 2024 (GLOBE NEWSWIRE) -- Eyenovia , Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive
07/23/24

Collaboration to focus on the development of a formulation of Senju’s SJP-0035 for use with Eyenovia’s Optejet ® dispensing technology, following consultation with FDA Chronic dry eye estimated to be a $5 billion global addressable market NEW YORK , July 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc.
06/28/24

NEW YORK , June 28, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (“Eyenovia” or the “Company”) (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced today that it has entered into a securities purchase agreement with an institutional investor and its current largest stockholder, providing for
05/15/24

Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the
05/14/24

Company to host an investor conference call and webcast at 4:30pm EDT NEW YORK , May 14, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that the Company will release
04/25/24

Company announces results from a Phase IV study of Mydcombi designed to characterize the efficacy and duration of the lowest deliverable dose (one 8µL spray per eye) Also announces upcoming ARVO presentation on the unique technology behind clobetasol that allows for future ophthalmic suspensions to
04/08/24

Company focusing on multi-billion dollar opportunity in pediatric progressive myopia represented by MicroPine, with interim analysis planned for 4Q 2024 and a potential NDA to the FDA in 2025 Continuing to advance commercialization of Mydcombi for mydriasis and preparing to launch clobetasol
04/03/24

Company to demonstrate Mydcombi™ and Avenova ® and Share Data for Clobetasol Propionate Ophthalmic Suspension 0.05% at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, April 5-8 , in Boston Will also demonstrate and discuss commercial terms for Mydcombi at the Vision
03/18/24

Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative pain and inflammation following ocular surgery Reacquired development and commercialization rights to MicroPine for progressive pediatric myopia in the U.S. and Canada   Continued to advance commercial
03/13/24

EMERYVILLE, Calif. and NEW YORK , March 13, 2024 (GLOBE NEWSWIRE) -- NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) and Eyenovia, Inc. (Nasdaq: EYEN) announced the signing of a co-promotion agreement to commercialize prescription ophthalmic products to eyecare professionals across the U.S.
03/11/24

Company to host an investor conference call and webcast at 4:30pm EDT NEW YORK , March 11, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic pharmaceutical technology company, today announced that the Company will release financial results for the fourth quarter
03/05/24

Approval based on nearly 9 out of 10 patients achieving complete absence of post-surgical pain and 6 out of 10 achieving total absence of inflammation within 15 days post-ocular surgery Eyenovia plans to launch in the U.S. as soon as this summer using its Mydcombi™ sales force providing
02/13/24

Redwood City, California to complement Eyenovia’s facility in Reno, Nevada as well as its contract manufacturer, Coastline International , to produce commercial supply of Mydcombi NEW YORK , Feb. 13, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company,
01/16/24

MicroPine, currently in late phase III for pediatric progressive myopia, to complement Eyenovia’s commercial-stage asset, Mydcombi, as well as its pre-PDUFA candidate, APP13007 Part of corporate strategy to expedite commercialization of advanced products using the Optejet device Market estimated to