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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NEW YORK--(BUSINESS WIRE)-- #EYEN--Dr. Julia Haller brings experience as an esteemed ophthalmic surgeon, scientist, professor, and business leader to her role as an Eyenovia director.

Eyenovia Announces Appointment of Renowned Ophthalmologist and Scientific Leader Dr. Julia Haller to its Board of Directors

Eyenovia, Inc. (EYEN) CEO Sean Ianchulev on Q4 2020 Results - Earnings Call Transcript

Announces MydCombi expected PDUFA date of October 28, 2021

Eyenovia Reports Fourth Quarter and Full Year 2020 Financial Results

NEW YORK & CHICAGO--(BUSINESS WIRE)-- #MydCombi--Eyenovia has tapped EVERSANA as exclusive distributor of its MydCombi product for pupil dilation in the U.S., pending the product's FDA approval.

Eyenovia and EVERSANA Announce Partnership to Support the Potential Launch and Commercialization of MydCombi™ for Mydriasis

NEW YORK--(BUSINESS WIRE)-- #Optejet--Eyenovia's MAP™ fixed-combination pharmaceutical for pupil dilation has been shown to be safe, effective and superior in comparative study.

Eyenovia Announces Publication of MIST Pivotal Studies Demonstrating the Efficacy and Safety of its MAP™ Fixed-Combination Tropicamide-Phenylephrine Product for Mydriasis

The stock price of Eyenovia, Inc. (Nasdaq: EYEN) has increased by over 15% pre-market. This is why it happened.

EYEN Stock Price Increases Over 15% Pre-Market: Why It Happened

NEW YORK--(BUSINESS WIRE)-- #mydriasis--FDA accepts Eyenovia's NDA for MydCombi, a unique fixed combination pupil dilation agent delivered with the Optejet. PDUFA date is expected 4Q 2021.

Eyenovia Announces FDA Acceptance of the MydCombi NDA

The webinar, “Presbyopia in Focus: Unlocking One of the Biggest Market Opportunities in Ophthalmology,” is scheduled for Monday, February 22, at 1:00pm ET The webinar, “Presbyopia in Focus: Unlocking One of the Biggest Market Opportunities in Ophthalmology,” is scheduled for Monday, February 22, at 1:00pm ET

Eyenovia to Host Key Opinion Leader Webinar on Presbyopia

NEW YORK--(BUSINESS WIRE)-- #Eyenovia--Eyenovia consultant Dr. David Wirta will speak at the Ophthalmology Innovation Summit Presbyopia Innovation Showcase on January 28.

Eyenovia to Present at the Ophthalmology Innovation Summit (OIS) Presbyopia Innovation Showcase

Today, we revisit a promising small ocular biopharma concern called Eyenovia for the first time in almost 18 months. The company continues to advance its pipeline and recently submitted a marketing application for approval for a new product.

Circling Back On Eyenovia

NEW YORK--(BUSINESS WIRE)-- #FDA--Eyenovia has submitted an NDA to the FDA for MydCombi, a unique fixed combination mydriatic (pupil dilation) agent delivered by the Optejet dispenser.

Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi Targeting 80 Million Patient Encounters in the U.S. Annually

NEW YORK--(BUSINESS WIRE)-- #Eyenovia--Eyenovia has enrolled its first patients in the Phase 3 VISION-1 Study of MicroLine for the improvement in near vision in patients with presbyopia.

Eyenovia Announces First Patients Enrolled in Phase 3 Study of MicroLine for Presbyopia

NEW YORK--(BUSINESS WIRE)-- #Eyenovia--Eyenovia obtains FDA acceptance of its IND application for MicroLine, a therapy designed for improvement in near vision in patients with presbyopia.

Eyenovia Announces FDA Acceptance of IND for MicroLine for Presbyopia, Clearing Path to Initiate Phase 3 VISION Trial by Year End

Eyenovia, Inc. (EYEN) CEO Sean Ianchulev on Q3 2020 Results - Earnings Call Transcript

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 2020 Results on Tuesday, November 10

Bausch Health Companies Inc

Bausch (BHC) acquires license for an investigational microdose formulation of atropine ophthalmic solution from Eyenovia.

Bausch Acquires License for Myopia Solution from Eyenovia

Company reaffirms near term milestones for the Mydcombi™ (MicroStat) NDA and the MicroLine presbyopia program Phase III results

Eyenovia to Host Investor Call to Discuss Recent Licensing Agreements Resulting in Total Potential License Payments and Development Cost Reimbursement and Savings of Approximately $100 Million

One year ago, I recommended Eyenovia's stock based on the company's effort in addressing several ophthalmic needs. Since that time, the stock has stagnated yet two collaborations have been announced.

Eyenovia: Continued Pipeline Progress, Attractive Valuation

LAVAL, QC and NEW YORK, Oct. 12, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), Bausch + Lomb, its leading global eye health business, and Eyenovia, Inc., (NASDAQ: EYEN) ("Eyenovia"), a clinical stage ophthalmic biopharmaceutical company developing a...

Bausch Health Licenses Eyenovia's Investigational Treatment For The Reduction Of Pediatric Myopia Progression In Children Ages 3-12

NEW YORK--(BUSINESS WIRE)-- #AAOPT--Drs. Siddarth Rathi, April Jasper to present latest analyses and updates from Eyenovia's clinical studies at the American Academy of Optometry 2020

Eyenovia to Present Clinical Study Updates at the American Academy of Optometry Annual Meeting

NEW YORK, Sept.  09, 2020  (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer and John Gandolfo, Eyenovia’s Chief Financial Officer, are scheduled to present at the 22nd Annual H.C. Wainwright Global Investment Conference being held virtually on September 14-16, 2020.

Eyenovia to Present at the 22nd Annual H.C. Wainwright Global Investment Conference

NEW YORK, Aug.  24, 2020  (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the underwriters of its previously announced public offering of common stock have fully exercised their option to purchase an additional 500,000 shares at the public offering price of $3.60 per share.

Eyenovia, Inc. Announces Underwriters’ Full Exercise of Over-Allotment Option in Public Offering

NEW YORK, Aug.  21, 2020  (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced the closing of its previously announced underwritten public offering of 3,333,334 shares of its common stock at a price to the public of $3.60 per share.

Eyenovia, Inc. Announces Closing of Offering of Common Stock

NEW YORK, Aug.  19, 2020  (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced the pricing of an underwritten public offering of 3,333,334 shares of its common stock at a price to the public of $3.60 per share. In addition, Eyenovia has granted the underwriters a 30-day option to purchase up to 500,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on August 21, 2020, subject to customary closing conditions.

Eyenovia, Inc. Prices Public Offering of Common Stock

NEW YORK, Aug.  18, 2020  (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. In connection with this offering, Eyenovia expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of common stock to be sold in the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Eyenovia.

News for Eyenovia Stock (EYEN)