News & Videos - EYENOVIA INC.

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 be dispensed with the Optejet® NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today provided an update on its two FDA-approved...

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 propionate ophthalmic suspension 0.05% for post-surgical management of pain and inflammation; both represent large multi-million-dollar opportunities Company exploring wide range of strategic alternatives...

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 Source Exchange, April 10-13, in Orlando NEW YORK, April 03, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today announced that the company will be...

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 operations with launch of Mydcombi™, FDA approval of manufacturing facility, onboarding of sales organization and signing of copromotion agreement Company to host conference call and webcast today, March...

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. Under the agreement, NovaBay will market Eyenovia’s clobetasol propionate ophthalmic suspension 0.05% (“Clobetasol”), a steroid indicated for the treatment of inflammation and pain following ocular...

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 ended December 31, 2023 on Monday, March 18 th , 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-877-407-9039...

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 pre-surgical pupil dilation and post-surgical care in an estimated $1.3 billion annual U.S. market NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic...

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, today announced that the company’s facility in Redwood City, California successfully completed FDA inspection for approval as a commercial manufacturing facility. The Redwood City facility will primarily...

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 be nearly $2 billion annually in the U.S. by Review of Myopia Management NEW YORK, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage, ophthalmic company, today...

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 Company to host conference call and webcast today, November 13 th , at 4:30 pm ET NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage, topical ophthalmic...

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 inflammation post ocular surgery, and incorporating its advanced Optejet® device with late-stage product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the Company will release financial...

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 ocular surgery, and incorporating its advanced Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today...

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, preparing for regulatory approval of APP130007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced Optejet ® device for use both in connection with its own...

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, 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 ocular...

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 ® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today...

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 therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced management will deliver a presentation at the H.C....

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 therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that it has entered into a Securities Purchase...

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 evaluate novel clobetasol formulations in its proprietary Optejet ® dispensing platform as a potential treatment for dry eye, estimated to be a $3.6 billion market in the U.S. NEW YORK, Aug. 16, 2023...

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 of guidance from FDA that establishes an efficient path forward for the program Company to host conference call and webcast today, August 10, at 4:30 pm ET NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE)...

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 drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced management will deliver a presentation and...