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

Eyenovia Reports First Quarter 2023 Financial Results and Provides Business Update

Represents the first FDA approved fixed-combination of tropicamide and phenylephrine for mydriasis Provides critical validation of key technology that is core to Eyenovia's proprietary development programs as well as current and future partnerships NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company 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 U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia's proprietary Optejet device to be approved by any regulatory authority.

Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company's Proprietary Optejet® Device Platform

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 2023 Results on Thursday, May 11

NEW YORK, April 24, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in connection with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced a poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2023 annual meeting, which is being held April 23-27 in New Orleans.

Eyenovia Announces Poster Presentation at ARVO 2023

Eyenovia, Inc. (NASDAQ:EYEN ) Q4 2022 Results Conference Call March 30, 2023 4:30 PM ET Company Participants Eric Ribner - IR Michael Rowe - CEO John Gandolfo - CFO Bren Kern - COO Operator Greetings, and welcome to the Eyenovia Fourth Quarter and Full Year 2022 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded.

Eyenovia, Inc. (EYEN) Q4 2022 Earnings Call Transcript

Announced FDA acceptance of Mydcombi New Drug Application (NDA) and PDUFA action date of May 8, 2023

Eyenovia Reports Fourth Quarter 2022 Financial Results and Provides Business Update

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

Eyenovia to Report Fourth Quarter and Full-Year 2022 Results on Thursday, March 30

I will update my previous two articles about Eyenovia. NDA accepted with no outside advisory committee formed to review their submission.

Eyenovia: Countdown To May 8, 2023

Collaboration will combine Eyenovia's Optejet® dispensing technology with Formosa's APNT™ nanoparticle formulation platform for the potential development of new topical therapeutics in high-value ophthalmic indications with significant unmet medical needs. Collaboration will combine Eyenovia's Optejet® dispensing technology with Formosa's APNT™ nanoparticle formulation platform for the potential development of new topical therapeutics in high-value ophthalmic indications with significant unmet medical needs.

Eyenovia Announces Development Collaboration Agreement with Formosa Pharmaceuticals

The collaboration will combine Formosa's proprietary APNT™ nanoparticle formulation platform with Eyenovia's Optejet® dispensing technology for the development of new ophthalmic therapies in high-value indications with significant unmet medical needs. TAIPEI , Feb. 15, 2023 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TWO) announced today that the company has entered into a collaboration agreement with Eyenovia, Inc. ("Eyenovia", NASDAQ: EYEN) for the development of novel ophthalmic therapeutics.

Formosa Pharmaceuticals Announces Development Collaboration Agreement with Eyenovia

Academic study found the Optejet® to be comparable to non-preserved drops in lessening the proinflammatory response Academic study found the Optejet® to be comparable to non-preserved drops in lessening the proinflammatory response

Eyenovia Reveals Positive Evidence That Optejet® Delivery Technology Decreased Inflammation From Preserved Glaucoma Solutions Compared to Drops

Booth to feature “smart” remote patient monitoring capabilities being developed for future versions of the company's novel Optejet® drug delivery technology

Eyenovia Announces Participation at the 2023 International Consumer Electronics Show

Agency assigns PDUFA action date of May 8, 2023

Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi™ for In-Office Pupil Dilation

I will update the history I've had with Eyenovia. I will share with the reader the interim and pending events since my previous article.

Hoping Eyenovia Has The Aye Votes From The FDA In The Near Future (Rating Downgrade)

Company also announces that Julia Haller, MD, is stepping down from its Board of Directors Company also announces that Julia Haller, MD, is stepping down from its Board of Directors

Eyenovia Announces Promotion of Bren Kern to Chief Operating Officer and Corporate Vice President

Transaction proceeds, together with cash on-hand, expected to fund operations through late 2023/early 2024, including potential FDA approval of MydCombi™ Transaction proceeds, together with cash on-hand, expected to fund operations through late 2023/early 2024, including potential FDA approval of MydCombi™

Eyenovia Announces $15 Million Credit Facility with Avenue Venture Debt Fund

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NEW YORK, Nov. 23, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (Nasdaq: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced management will present at the BTIG Ophthalmology Day taking place virtually on November 29, 2022. Presentation details are below:

Eyenovia to Present at Upcoming BTIG Ophthalmology Day

Eyenovia, Inc. (NASDAQ:EYEN ) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Eric Ribner - Investor Relations Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Conference Call Participants Leonard Yaffe - Stoc Doc Partners Operator Good day and welcome to the Eyenovia's Third Quarter 2022 Earnings Call. Today's conference is being recorded.

Eyenovia, Inc. (EYEN) CEO Michael Rowe on Q3 2022 Results - Earnings Call Transcript

Announced positive results from the second Phase 3 study of MicroLine in presbyopia, VISION-2; Company planning to meet with the FDA to gain alignment on regulatory path forward as a drug/device combination product

Eyenovia Reports Third Quarter 2022 Financial Results and Provides Business Update

Company to host an investor conference call and webcast at 4:30pm ET on that day Company to host an investor conference call and webcast at 4:30pm ET on that day

Eyenovia to Report Third Quarter 2022 Results on Thursday, November 10

NEW YORK, Oct. 21, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications, today announced the company will present at the 2022 American Academy of Optometry's Annual Meeting, which is taking place from October 26-29, 2022, at the at the San Diego Convention Center. Presentation details are below:

Eyenovia to Present at the American Academy of Optometry's Annual Meeting

NEW YORK, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced positive results from its VISION-2 Phase 3 study of MicroLine as a potential topical, on-demand treatment for presbyopia.

Eyenovia Announces Positive Results from VISION-2 Phase 3 Study of MicroLine as a Potential On-Demand Treatment for Presbyopia

NEW YORK, Sept. 30, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications, today announced the planned retirement of lead independent director, Ken Lee, Jr., effective today, September 30, 2022.

Eyenovia Announces Planned Retirement of Lead Independent Director Ken Lee, Jr.

NEW YORK, Sept. 07, 2022 (GLOBE NEWSWIRE) -- 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 they will present at the R.W. Baird Global Healthcare Conference taking place on September 13-14, 2022 at the Intercontinental New York Barclay Hotel and the Ladenburg Thalmann Healthcare Conference taking place on September 29, 2022 at the Sofitel Hotel in New York City. Presentation details are below:

News for Eyenovia Stock (EYEN)