Eyenovia

Eyenovia, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of ophthalmology products. The company offers a piezo-print technology to deliver micro-doses of micro-therapeutics for the eyes. Its products include MicroProst, MicroStat, MicroTears, and MicroPine. The firm is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression, and mydriasis. The company was founded by Sean Ianchulev on March 12, 2014 and is headquartered in New York, NY.

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Eyenovia anticipates FDA approval for MydCombi, focusing on growth

Eyenovia's Q4 2022 call highlighted financial results, key milestones, and upcoming FDA approval for MydCombi. The company's focus on product candidates and strategic partnerships positions it for growth.

Eyenovia reports FDA approval for MydCombi, eyes ophthalmology market growth

Eyenovia's Q1 2023 performance reflects financial discipline and strategic progress in product development and partnerships, positioning the company for future growth.
The company's focus on efficiency, market potential in ophthalmology, and innovative products like Optejet present opportunities for expansion and value creation.
Challenges lie in raising awareness about new products, balancing financial discipline with growth ambitions, and successfully executing product launches in competitive markets.

Eyenovia reports Q2 loss but hits milestones, eyes growth opportunities

Eyenovia's Q2 2023 performance reflects a net loss but highlights successful commercial milestones for Mydcombi and progress on Apersure.
The company's strengths lie in innovation with Optejet technology, expanding manufacturing capabilities, and promising licensing agreements.
Challenges include managing losses, finalizing partnerships, and meeting regulatory timelines, while opportunities exist in partnerships, market expansion, and revenue growth.
Overall, Eyenovia's strategic focus on product development, partnerships, and financial management positions it for future growth and success in the pharmaceutical industry.

Eyenovia reports Q3 losses, eyes FDA approvals and strategic partnerships

Eyenovia's Q3 performance reflects strategic investments in product development and partnerships to drive future growth. The company's focus on innovative products like Mydcombi and APP13007 positions them well for market expansion. While facing financial challenges and regulatory risks, Eyenovia's strong leadership and partnership progress indicate a promising outlook for the future.

Eyenovia reports Q4 progress with FDA approvals and revenue strategies

Eyenovia's Q4 2023 earnings call highlighted progress in product development, manufacturing capabilities, and revenue potential.
The company's focus on innovation, competitive pricing, and strategic partnerships positions it for future growth and market success.
Challenges include market competition, operational expenses, and the need for promotional efforts to drive product adoption.
Opportunities lie in collaborations, product launches, and strategic initiatives to enhance market presence and drive revenue growth.

Eyenovia reports Q1 loss but eyes revenue growth opportunities

Eyenovia's Q1 2024 performance reflects a focus on commercialization, pipeline advancement, and strategic collaborations amidst a net loss and increased expenses.
With a strong product portfolio, differentiated offerings, and key partnerships, Eyenovia is well-positioned to capitalize on revenue opportunities in the eye care market.
While facing challenges in managing costs and securing capital, Eyenovia has opportunities to drive growth through product launches, market expansion, and regulatory milestones.

Eyenovia reports Q2 loss but sees growth potential in innovations

Eyenovia's Q2 2024 performance reflects strategic investments in product development and partnerships, with a focus on innovative technologies like Optejet.
While facing financial challenges from increased expenses, Eyenovia's revenue potential from licensing agreements and product pipeline remains strong.
The company's opportunities lie in capitalizing on Optejet advancements, expanding market reach through collaborations, and navigating regulatory milestones for key products.

Eyenovia advances in pediatric eye care amidst financial challenges

Eyenovia's Q3 2024 performance reflects progress in innovation and market expansion, despite financial losses.
The company's strengths lie in pediatric eye care, self-administration technology, and strategic collaborations driving revenue potential.
Challenges include financial losses, cost management, and competitive pressures, while opportunities exist in product validation, market expansion, and revenue growth.

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Eyenovia, Inc. (NASDAQ:EYEN ) Q3 2023 Earnings Conference Call November 13, 2023 4:30 PM ET Company Participants Glenn Garmont - LifeSci Partners, IR Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Bren Kern - Chief Operating Officer Conference Call Participants John Boyle - William Blair Raymond Wu - Ladenburg Thalmann Len Yaffe - Stoc*Doc Partners Operator Good day, ladies and gentlemen. And welcome to Eyenovia's Third Quarter of 2023 Earnings Conference Call.

Eyenovia, Inc. (EYEN) Q3 2023 Earnings Call Transcript

Acquired U.S. commercial rights to APP13007, currently under FDA review for post-surgical ocular pain and inflammation, from Formosa Pharmaceuticals

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

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Company to host an investor conference call and webcast at 4:30pm EDT Company to host an investor conference call and webcast at 4:30pm EDT

Eyenovia to Report Third Quarter 2023 Results on Monday, November 13

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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 announced that the FDA has approved Eyenovia's Supplemental New Drug Application (sNDA), adding Coastline International as a contract manufacturer. Coastline will manufacture cartridge subassemblies for Mydcombi, the only FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis (office-based pupil dilation).

Eyenovia Announces FDA Approval of Coastline International as Contract Manufacturer to Initiate Mydcombi Commercial Production

Course to provide ophthalmic technicians with background on the Optejet dispensing technology and training on the use of Mydcombi™ for mydriasis

Eyenovia to Sponsor Course on Drug Delivery Innovation at IJCAHPO's 51st Annual Continuing Education (ACE) Program

In rigorous testing, the Optejet remained contaminant-free when subjected to a microbial load that exceeds typical environmental conditions

Eyenovia to Present Data on Preservative-Free Microbial Integrity of the Optejet®

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 announced that Michael Rowe, CEO, will be participating in a panel discussion at the Cantor Global Healthcare Conference, which is taking place September 26-28, 2023, in New York.

Eyenovia to Participate in Panel Discussion at Cantor Global Healthcare Conference

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. Wainwright 25th Annual Global Investment Conference, which is taking place on September 11-13, 2023 at the Lotte New York Palace Hotel.

Eyenovia to Present at Upcoming H.C. Wainwright 25th Annual Global Investment Conference

Eyenovia has obtained the first required state pharmacy license from New York, allowing them to obtain the first commercial sale of their drug candidate MydCombi. The company has conducted training sessions in California in anticipation of obtaining licensing approval in the state, which will expand their market reach. Eyenovia has acquired the exclusive US rights to distribute and sell APP13007, an ophthalmic nanosuspension drug, from Formosa Pharmaceuticals, expanding their product portfolio.

Eyenovia: It Is Now Time To See Positive Results In Their Marketing Efforts

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 Agreement with a leading health care investor in an offering of 4,198,633 shares of its common stock, pre-funded warrants to purchase up to 2,252,979 shares of common stock and warrants to purchase up to 4,838,709 shares of common stock (the "Offering"). The combined offering price for each share of common stock and accompanying warrant is $1.86, and the offering price for each pre-funded warrant and accompanying warrant is $1.85.

Eyenovia Announces $12 Million Registered Direct Offering

APP13007, if approved, may have an advantageous profile in dosing frequency and side effects while reducing the inflammation and pain associated with ocular surgery

Eyenovia Acquires U.S. Commercial Rights to APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension, 0.05%) from Formosa Pharmaceuticals

TAIPEI , Aug. 16, 2023 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has entered into a licensing agreement with Eyenovia, Inc. ("Eyenovia", NASDAQ: EYEN), whereby Eyenovia obtains exclusive U.S. rights for the commercialization of APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for the treatment of inflammation and pain following ocular surgery.  APP13007 is currently under review by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of March 4, 2024.

Formosa Pharmaceuticals Announces Licensing Agreement with Eyenovia, Inc., for the Commercialization of APP13007 for the Treatment of Inflammation and Pain Following Ocular Surgery

Eyenovia, Inc. (NASDAQ:EYEN ) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Eric Ribner - Investor Relations Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Bren Kern - Chief Operating Officer Conference Call Participants Matthew Caufield - H.C. Wainwright Raymond Wu - Ladenburg Thalmann Operator Greetings.

Eyenovia, Inc. (EYEN) Q2 2023 Earnings Call Transcript

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 ®

Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update

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 participate in a panel discussion at the H.C. Wainwright 3rd Annual Ophthalmology Day, which is taking place virtually on August 16, 2023. Presentation and panel details are below:

Eyenovia to Present at Upcoming H.C. Wainwright 3rd Annual Ophthalmology Virtual Conference

Eyenovia to Report Second Quarter 2023 Results on Thursday, August 10

Represents the first FDA approved and commercially available fixed combination of tropicamide and phenylephrine for pupil dilation

Eyenovia Announces First Commercial Sale of Mydcombi™

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 drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the company was added to the small cap Russell 2000® and broad market Russell 3000® Indexes effective today.

Eyenovia Announces Addition to Russell 2000® and Russell 3000® Indexes

NEW YORK--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”) announces its investigation of Eyenovia, Inc. (Nasdaq: EYEN) concerning the Company and its directors' and officers' possible violations of state laws. If you own Eyenovia stock, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Tom Kennedy, of GPM, 230 Park Avenue, Suite 358, New York, NY 10169 at tkennedy@gla.

Glancy Prongay & Murray LLP Announces Investigation of Eyenovia, Inc. (EYEN)

Eyenovia is stepping up the capabilities of its facilities and taking advantage of the thriving innovation culture and expertise in Reno, Nevada, and Redwood City, California NEW YORK, NY / ACCESSWIRE / June 6, 2023 / Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company commercializing and developing the Optejet® device for use both in connection with its own mydriasis product and product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, is proud to announce the expansion of its U.S. manufacturing facilities in Redwood City, California, and Reno, Nevada. The Bay Area is known for its thriving biotech industry, and in Reno, the medical device and technology sectors are booming in part due to having the largest industrial park in the world, which are some of the driving factors behind Eyenovia's expansion plans.

Eyenovia Expands Its US Manufacturing Capabilities

Presentation to highlight recent FDA approval of Mydcombi™ for mydriasis which leverages Eyenovia's novel Optejet dispensing device

Eyenovia Announces Presentation at the OCTANE Ophthalmology Tech Forum 2023

I will update for my readers on the background of Eyenovia. I will give the readers an explanation of the need for their business model and the advantages it offers.

Eyenovia: Say Goodbye To The Eye Dropper And Welcome Optejet To The Market Place

Announced FDA approval of Mydcombi™, a fixed dose combination of tropicamide and phenylephrine for mydriasis, the first FDA approved product to utilize the Optejet ®

News for Eyenovia Stock (EYEN)