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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Earnings data Q2 2024

Earnings data Q3 2024

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.

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Eyenovia (EYEN) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

All You Need to Know About Eyenovia (EYEN) Rating Upgrade to Buy

Eyenovia, Inc. (NASDAQ:EYEN ) Q1 2024 Results Conference Call May 14, 2024 4:30 PM ET Company Participants Eric Ribner - IR Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Bren Kern - Chief Operating Officer Conference Call Participants Matt Kaplan - Ladenburg Matthew Caufield - H.C. Wainwright Kemp Dolliver - Brookline Capital Markets Operator Good afternoon, ladies and gentlemen, and welcome to the Eyenovia First Quarter 2024 Earnings Conference Call.

Eyenovia, Inc. (EYEN) Q1 2024 Earnings Call Transcript

Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine

Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol

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 First Quarter 2024 Results on Wednesday, May 15th

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)

Eyenovia Provides Clinical and Scientific Update on FDA-Approved Products Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension

Eyenovia (EYEN) plunges 18% after sharing plans to consider strategic alternatives involving the sale of the company or assets, amid a severe cash crunch and poor performance of marketed drugs.

Eyenovia (EYEN) Down 18% on Disappointing Corporate Update

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-billion dollar product for pediatric progressive myopia (MicroPine) and initiated a process to explore strategic alternatives to maximize shareholder value. As part of this process, the Company plans to consider a wide range of options, including potential sale of assets of the Company, a sale of the Company, a merger, or other strategic action. In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.

Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities

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

Eyenovia to Feature its Suite of Commercial Products and the Optejet Dispenser at Upcoming National Eyecare Meetings

Eyenovia, Inc. (EYEN) Q4 2023 Earnings Call Transcript

Eyenovia, Inc. (EYEN) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.17 per share a year ago.

Eyenovia, Inc. (EYEN) Reports Q4 Loss, Misses Revenue Estimates

Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative pain and inflammation following ocular surgery

Eyenovia Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

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 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 located across the U.S.

NovaBay Pharmaceuticals and Eyenovia to Co-Promote Prescription Ophthalmic Products to U.S. Eyecare Professionals

Eyenovia to Report Fourth Quarter 2023 Results and Provide Business Update on Monday, March 18th

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 Congratulates Formosa Pharmaceuticals on FDA Approval of Clobetasol Propionate Ophthalmic Suspension 0.05% for the Treatment of Post-operative Inflammation and Pain Following Ocular Surgery

The U.S. Food and Drug Administration approved Eyenovia's eye drops to reduce inflammation and pain in patients who have undergone eye surgery, Formosa Pharmaceuticals said on Monday.

US FDA approves Eyenovia's eye drug, Formosa Pharma says

Eyenovia has received FDA approval for its Optejet system, which revolutionizes how eye medications are dosed, resolving limitations and adverse events caused by traditional eye droppers. The company's manufacturing facilities, including two in the USA and one in Mexico, have received FDA certification, ensuring the safety and quality of their products. Eyenovia is preparing for the official launch of its first FDA-approved product, MydCombi, and has upcoming events, including financial results and an FDA decision for another drug.

Eyenovia: Racing Toward The Finish Line

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

Eyenovia Announces FDA Approval of Redwood City as Commercial Manufacturing Facility

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

Eyenovia Re-Acquires Development and Commercialization Rights to MicroPine in the U.S. and Canada

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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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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).

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