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
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 11/18/2024 | $12.00 → $2.00 | Buy → Neutral | H.C. Wainwright |
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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
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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. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery Appointed Andrew Jones as Chief Financial Officer Company to host conference call and webcast today, November 12th, at 4:30 pm ET NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company developing and commercializing adv
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 dispensing platform, today announced that the Company will release financial results for the third quarter ended September 30, 2024 on Tuesday, November 12th, 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 reference Conference ID# 13748714. To access t
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 activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years Announced development collaborations with Formosa, Senju and SGN to leverage the Optejet for the $5 billion global dry eye disease market Company to host conference call and webcast today, August 12th, a
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 release financial results for the second quarter ended June 30, 2024 on Monday, August 12th, 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 reference Conference ID# 13747356. To access the Call me™ feature, which avoids having to wait for an operat
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
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, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced that a review of the CHAPERONE data by an independent Data Review Committee (DRC) found that the trial is not meeting its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years. CHAPERONE is Eyenovia's Phase 3 study evaluating its proprietary drug-device combination of low-dose atropine in the Company's
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. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery Appointed Andrew Jones as Chief Financial Officer Company to host conference call and webcast today, November 12th, at 4:30 pm ET NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company developing and commercializing adv
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 dispensing platform, today announced that the Company will release financial results for the third quarter ended September 30, 2024 on Tuesday, November 12th, 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 reference Conference ID# 13748714. To access t
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 demonstrating that clinically relevant mydriasis can be achieved with a half-dose per eye NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced a publication in the Journal of Ocular Pharmacology and Therapeutics as well as an upcoming presentation at the American Academy of Optometry's "Academy 2024 Indianapolis" Annual Me
NEW YORK, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced a presentation at the American Academy of Ophthalmology (AAO) 2024 Expo, which is being held October 19-21, in Chicago. The presentation will detail the results of a successful Phase 3 study (CPN-302) of clobetasol propionate suspension 0.05% (APP13007) that led to its approval by the U.S. Food and Drug Administration as a treatment for inflammation and pain following ocular surgery. Eyenovia announced the U.S. launch and commercial availability of clobetasol on September 26, 2024. "We are very pleased to see the results from this successful Phase 3 study of clo
NEW YORK, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced that the Company has commenced manufacturing of registration batches of its FDA-approved mydriasis product, Mydcombi, a key step in the approval process for its state-of-the-art Gen-2 Optejet dispensing platform. Mydcombi will undergo 12-month stability testing and other functional testing in the Gen-2 Optejet device that is consistent with feedback from the Type-C meeting on Eyenovia's device qualification plan that the Company received from the FDA in July. "We were very pleased to have received feedback from the FDA that was very consistent with our Gen-2 qualifi
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 securities purchase agreement with a healthcare focused institutional investor for the purchase and sale of 8,695,653 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 8,695,653 shares of common stock in a registered direct offering at a combined offering price of $0.46 per share and accompanying warrant. The warrants have an exer
NEW YORK, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% ("Clobetasol"), approved by the FDA for the treatment of post-operative inflammation and pain following ocular surgery. "The commercial launch of Clobetasol represents a significant milestone for our company, and as the first new ophthalmic steroid to be approved in more than 15 years, a meaningful advancement in the field of ocular surgery," stated Michael Rowe, Chief Executive Officer of Eyenovia. "With its efficacy and safety profile, convenient twice-a-day dosing reg
TAIPEI, Sept. 9, 2024 /PRNewswire/ -- Formosa Pharmaceuticals, Inc. (hereinafter referred to as "Formosa Pharma," 6838.TW) announced the successful first shipment to the United States of its new ophthalmic drug, Clobetasol Propionate Ophthalmic Suspension, 0.05% (APP13007), manufactured by Bora Pharmaceuticals Ophthalmic (hereinafter referred to as "Bora," 6472.TW). Formosa Pharma's U.S. partner, Eyenovia, Inc. (NASDAQ:EYEN), has initiated the pre-launch activities for APP13007 and is expected to begin commercialization in late September. APP13007, developed through Formosa Ph
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 progressive myopia, today announced that its strategic partner, Taiwan-based Formosa Pharmaceuticals (TWO:6838), was granted a Taiwan Export License for clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate") to allow for shipment of commercial product to the U.S. Clobetasol is a powerful steroid approved for reducing inflammation and pain following the approximately seven million ocular surgeries performed annually in the U.S. In August 2023, Eyenovia secur
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 progressive myopia, today announced the appointment of experienced finance and accounting executive Andrew Jones as Chief Financial Officer. Mr. Jones brings to the Eyenovia team more than 30 years of diverse finance and accounting leadership experience spanning therapeutics and medical technology/devices, most recently serving as Chief Financial Officer of NovaBay Pharmaceuticals, Inc., a publicly traded, commercial stage ophthalmic company. Eyenovia's current CFO, John Gandolfo, is retiring and will remain with
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
H.C. Wainwright downgraded Eyenovia from Buy to Neutral and set a new price target of $2.00 from $12.00 previously
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
HC Wainwright & Co. analyst Matthew Caufield reiterates Eyenovia (NASDAQ:EYEN) with a Buy and maintains $12 price target.
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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