Eyenovia, Inc., a clinical stage ophthalmic company, engages in developing therapeutics based on its proprietary microdose array print (MAP) platform technology. The company focuses on to develop clinical microdosing of formulations of ophthalmic pharmaceutical agents using its Optejet branded targeted ocular delivery system. Its pipelines focus on the development of therapeutic indications for patients with progressive myopia and age-related near vision impairment or presbyopia indications; and microdose fixed combination ophthalmic pharmaceutical for mydriasis to address the eye exams with pupil dilation. The company's product candidates in pipeline include MicroLine, which is in Phase III clinical development program with indications for the improvement in near vision in people with presbyopia; MicroPine, which is in Phase III clinical development program with indications for pediatric myopia progression (near-sightedness); and MydCombi, which is in Phase III clinical development program with indications for pharmaceutical mydriasis. It has a license agreement with Bausch Health Ireland Limited to develop and commercialize MicroPine in the United States and Canada; and a license agreement with Arctic Vision (Hong Kong) Limited to develop and commercialize MicroPine and MicroLine in China and South Korea. The company was formerly known as PGP Holdings V, Inc. and changed its name to Eyenovia, Inc. in May 2014. Eyenovia, Inc. was incorporated in 2014 and is headquartered in New York, New York.
IPO Year: 2018
Exchange: NASDAQ
Website: eyenovia.com
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Submission status for EYENOVIA INC.'s drug MYDCOMBI (ORIG-1) with active ingredient TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE has changed to 'Approval' on 05/05/2023. Application Category: NDA, Application Number: 215352, Application Classification: Type 5 - New Formulation or New Manufacturer
NovaBay® Pharmaceuticals, Inc. (NYSE:NBY), a company developing and commercializing high-quality eyecare products, and Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, have commenced activities under a previously announced co-promotion agreement. Under the agreement, Eyenovia is leveraging its ten-person field salesforce to promote NovaBay's Avenova Antimicrobial Lid & Lash Solution to large ophthalmic surgery centers along with one of Eyenovia's other FDA-approved products, MydCombi for mydriasis. In parallel, NovaBay has initiated reconnaissance and market preparation activities ahead
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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 treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 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 myopia, today announced its financial and operating results for the fi
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 financial results for the first quarter ended March 31, 2024 on Wednesday, May 15th, 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 1-800-717-1738 (domestic) or 1-646-307-1865 (international). To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of
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 18th, at 4:30 pm ET NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today announced its financial and operating results for the
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 18th, 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 (domestic) or 1-201-689-8470 (international) and referencing conference ID 13744365. To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of the conferen
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 company, today congratulates Formosa Pharmaceuticals (TWO:6838) on the FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of post-operative inflammation and pain following
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 announced that it has re-acquired the rights to MicroPine in the U.S. and Canada. MicroPine, an investigational eight microliter ophthalmic spray of atropine delivered by Eyenovia's proprietary Opteje
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 13th, at 4:30 pm ET NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage, topical ophthalmic company leveraging its Optejet® dispensing technology for both internally developed and acquired programs as well as out-licensing for additional indications, today announced its financial and opera
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 results for the third quarter ended September 30, 2023 on Monday, November 13, 2023, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ED
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 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis and deve
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) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis and developing the Optejet® device for use both i
Partnership co-promoting NovaBay's Avenova® Antimicrobial Lid & Lash Solution to large ophthalmic surgery centers along with one of Eyenovia's FDA-approved product MydCombi™ Preparing for Eyenovia's launch of clobetasol propionate ophthalmic suspension, 0.05% to U.S. eyecare professionals NovaBay® Pharmaceuticals, Inc. (NYSE:NBY), a company developing and commercializing high-quality eyecare products, and Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, have commenced activities under a previously announced co-promotion agreement. Under the agreement, Eyenovia is leveraging its te
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 the purchase and sale of 7,575,757 shares of common stock, and warrants to purchase up to 7,575,757 shares of common stock (the "Offering"). The combined offering price for each share of common stock and accompanying warrant is $0.66. The warrants will have an exercise price of $0.69 per share, are exercisable six months from issuance, and will expire 5.5 years from the date of issuance. The clos
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 treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 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 myopia, today announced its financial and operating results for the fi
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 financial results for the first quarter ended March 31, 2024 on Wednesday, May 15th, 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 1-800-717-1738 (domestic) or 1-646-307-1865 (international). To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of
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 products. Phase IV study of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% Eyenovia announced today results from a Phase IV study of Mydcombi® designed
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 2025Continuing 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 opportunitiesCompany exploring wide range of strategic alternatives NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today announced its plans for accelerating development of its potential multi-billi
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 conducting demonstrations of its portfolio of commercial products at two upcoming ophthalmology medical meetings. "Our presence at national medical and commercial meetings like these are key
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 18th, at 4:30 pm ET NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today announced its financial and operating results for the
EMERYVILLE, Calif. and NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- NovaBay Pharmaceuticals, Inc. (NYSE: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 surgery, through its U.S. physician-dispensed channel. Eyenovia will market NovaBay's prescription Avenova® Antimicrobial Lid & Lash Solution through its Mydcombi and Clobetasol sales representatives strategically loc
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 18th, 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 (domestic) or 1-201-689-8470 (international) and referencing conference ID 13744365. To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of the conferen
NEW YORK, July 27, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, today announced the appointment of current Chief Operating Officer Michael Rowe as the Company's new Chief Executive Officer, effective August 1, 2022. Mr. Rowe's appointment follows the company's nationwide search and interviews with multiple candidates. Mr. Rowe has also been appointed to Eyenovia's Board of Directors, increasing the Board to nine seats following recent appointments of Drs. Strahlman and Palanki as new independent directors, announced in July. Eyenovia's current Chief Exec
NEW YORK, July 18, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, today provided an update on its expanded manufacturing capabilities and also announced the appointment of Bren Kern as Senior Vice President of Manufacturing and Operations. Redwood City, CA Facility The Company today announced that its new manufacturing facility in Redwood City, CA is operational. The facility, which is located in close proximity to Silicon Valley-based vendors and customers, will primarily focus on Optejet® manufacturing finishing operations, including drug loading, label
NEW YORK, July 07, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, today announced that it has appointed Dr. Ellen Strahlman and Dr. Ram Palanki as new and independent members of its Board of Directors. With these appointments, the Eyenovia Board will expand to eight seats, from six currently. "I could not be more pleased to welcome Drs. Strahlman and Palanki to our Board and look forward to their immediate contributions," stated Dr. Sean Ianchulev, chief executive officer and chief medical officer of Eyenovia. "Each brings decades of medical technology, cl
NEW YORK--(BUSINESS WIRE)--Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced the appointment of renowned ophthalmologist and scientific leader, Julia Haller, M.D., to its Board of Directors. “We are delighted to welcome Dr. Haller to our Board of Directors at such an exciting time for Eyenovia,” commented Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. “We believe that Dr. Haller’s decades of experience as an esteemed ophthalmic surgeon, scientist, professor, and business leader will be invalu
MENLO PARK, Calif.--(BUSINESS WIRE)--Revelation Biosciences Inc. (Revelation), a clinical stage life sciences company focused on the development of immunologic-based therapies for the prevention and treatment of disease, announced today the appointment of Curt LaBelle, M.D. to the Company’s Board of Directors (Board). “I am very impressed with all that the Revelation team accomplished in 2020,” said Dr. LaBelle. “I look forward to using my expertise to help the company as it advances forward in development.” "We extend our warmest welcome to Dr. LaBelle and are delighted to add another talented leader to our Board,” said James Rolke, Chief Executive Officer of Revelation. “His e
HC Wainwright & Co. reiterated coverage of Eyenovia with a rating of Buy and set a new price target of $8.00 from $6.00 previously
Northland Capital initiated coverage of Eyenovia with a rating of Outperform and set a new price target of $10.00
Northland Securities initiated coverage of Eyenovia with a rating of Outperform
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