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News Releases

News Releases

11/13/23

Acquired U.S. commercial rights to APP13007, currently under FDA review for post-surgical ocular pain and inflammation, from Formosa Pharmaceuticals Announced FDA approval of Coastline International as contract manufacturer for Mydcombi cartridge subassemblies and preparations for national launch
11/06/23

Company to host an investor conference call and webcast at 4:30pm EDT NEW YORK , Nov. 06, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP13007 for relief of pain and
11/02/23

Anticipates having product available to ship in January 2024 NEW YORK , Nov. 02, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP13007 for relief of pain and inflammation post
10/30/23

Course to provide ophthalmic technicians with background on the Optejet dispensing technology and training on the use of Mydcombi™ for mydriasis NEW YORK , Oct. 30, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis,
10/09/23

In rigorous testing, the Optejet remained contaminant-free when subjected to a microbial load that exceeds typical environmental conditions Presentation to be made at the American Academy of Optometry’s “Academy 2023 New Orleans” Annual Meeting NEW YORK , Oct.
09/21/23

NEW YORK , Sept. 21, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of AP13007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced Optejet ®
09/07/23

NEW YORK , Sept. 07, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), a commercial-stage ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray for mydriasis) and developing the Optejet® device for use both in connection with its own drug-device
08/24/23

NEW YORK , Aug. 24, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray for mydriasis) and developing the Optejet® device for use both in connection with its own drug-device
08/16/23

APP13007, if approved, may have an advantageous profile in dosing frequency and side effects while reducing the inflammation and pain associated with ocular surgery Further leverages Eyenovia’s Mydcombi sales force and represents additional near-term potential revenue source Eyenovia plans to
08/10/23

Announced FDA approval of and first commercial sale of Mydcombi™, the only fixed dose combination of tropicamide and phenylephrine for mydriasis and the first FDA approved product to utilize the Optejet ® Continued to advance its Phase 3 Apersure™ (Microline) presbyopia candidate following receipt
08/09/23

NEW YORK , Aug. 09, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis and developing the Optejet ® device for use both in connection with its own
08/07/23

Company to host an investor conference call and webcast at 4:30pm EDT NEW YORK , Aug. 07, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis and developing the Optejet® device
08/03/23

Represents the first FDA approved and commercially available fixed combination of tropicamide and phenylephrine for pupil dilation Validates Eyenovia’s proprietary Optejet ®   dispensing platform World-renowned board-certified ophthalmologist Dr. Nathan M.
06/26/23

NEW YORK , June 26, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic technology company preparing for the launch of Mydcombi™ (tropicamide+phenylephrine ophthalmic spray for mydriasis) and developing the Optejet ® device for use both in connection with its own
06/01/23

Presentation to highlight recent FDA approval of Mydcombi™ for mydriasis which leverages Eyenovia’s novel Optejet dispensing device Optejet represents the first true advancement in the topical administration of ophthalmic medications in more than 100 years NEW YORK , June 01, 2023 (GLOBE NEWSWIRE)
05/11/23

Announced FDA approval of Mydcombi™, a fixed dose combination of tropicamide and phenylephrine for mydriasis, the first FDA approved product to utilize the Optejet ® Received feedback from FDA on its Phase 3 Microline presbyopia candidate that provides a clear and efficient path forward for the
05/08/23

Represents the first FDA approved fixed-combination of tropicamide and phenylephrine for mydriasis Provides critical validation of key technology that is core to Eyenovia’s proprietary development programs as well as current and future partnerships NEW YORK , May 08, 2023 (GLOBE NEWSWIRE) --
05/04/23

Company to host an investor conference call and webcast at 4:30pm EDT NEW YORK , May 04, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic
04/24/23

NEW YORK , April 24, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in connection with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as
03/30/23

Announced FDA acceptance of Mydcombi New Drug Application (NDA) and PDUFA action date of May 8, 2023 Announced positive results from Microline Phase 3 program as a potential treatment for presbyopia and received feedback from the FDA outlining a clear path forward for the program Entered into
03/23/23

Company to host an investor conference call and webcast at 4:30 pm ET NEW YORK , March 23, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet ® delivery system for use both in combination with its own drug-device therapeutic
02/28/23

NEW YORK , Feb. 28, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet ® delivery system for use both in connection with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as
02/15/23

Collaboration will combine Eyenovia’s Optejet® dispensing technology with Formosa’s APNT™ nanoparticle formulation platform for the potential development of new topical therapeutics in high-value ophthalmic indications with significant unmet medical needs. NEW YORK , Feb.
01/12/23

Academic study found the Optejet® to be comparable to non-preserved drops in lessening the proinflammatory response NEW YORK , Jan. 12, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc.  (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet ® delivery system for use both in