Welcome to our dedicated page for Eyenovia news (Ticker: EYEN), a resource for investors and traders seeking the latest updates and insights on Eyenovia stock.
Eyenovia, Inc. (NASDAQ: EYEN) is a pioneering biopharmaceutical company specializing in the development and commercialization of next-generation topical eye treatments. Utilizing its proprietary Microdose Array Print (MAP) platform technology, Eyenovia is at the forefront of transforming ophthalmic care through precision-targeted ocular delivery systems.
The company’s flagship technology, branded as Optejet, aims to revolutionize the delivery of ophthalmic medications. This high-precision device offers a significant improvement over conventional eye droppers by ensuring better safety, tolerability, and patient compliance. The Optejet technology is designed to enhance the delivery success of both novel and existing pharmaceutical agents, making it a versatile tool for a wide range of eye conditions.
Eyenovia's current focus includes the commercialization of Mydcombi™ (a combination of tropicamide and phenylephrine ophthalmic spray) for mydriasis and the newly FDA-approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for post-operative inflammation and pain relief following ocular surgery. The company also boasts a promising pipeline, with late-stage development projects such as MicroPine for myopia progression and Apersure for presbyopia, both leveraging the Optejet delivery system.
Recent achievements highlight Eyenovia’s innovative prowess. The FDA's approval of clobetasol propionate ophthalmic suspension 0.05%, a first in over 15 years for new ophthalmic steroids, underscores the company’s commitment to bringing groundbreaking therapies to market. This novel formulation, which leverages Formosa Pharmaceuticals' APNT™ nanoparticle technology, has shown superior efficacy in reducing post-operative inflammation and pain, positioning it to capture a significant share of the $1.3 billion annual market for topical ophthalmic steroids.
Eyenovia's strategic collaborations further enhance its capabilities. The company has partnered with Arctic Vision for the development of MicroPine in China and South Korea, and with major players like Formosa Pharmaceuticals and AimMax Therapeutics to advance its product offerings. These collaborations reflect Eyenovia’s strategic approach to global market penetration and its commitment to addressing critical unmet needs in ophthalmic care.
The company continues to engage with the ophthalmic community through active participation in medical and commercial meetings such as ASCRS and Vision Source Exchange. These platforms allow Eyenovia to demonstrate its full suite of commercial products, including Mydcombi and Avenova, while establishing itself as the partner of choice for leading ophthalmic and optometric practices.
As Eyenovia progresses towards its commercialization goals, it remains focused on strategic alternatives to maximize shareholder value, including potential mergers, acquisitions, or partnerships. The company's commitment to innovative eye care solutions, patient-centric product development, and robust commercialization strategies positions it well for future growth and industry leadership.
For more detailed information, visit the Eyenovia corporate website or its investor relations page.
Eyenovia, Inc. (NASDAQ: EYEN) has announced the promotion of Bren Kern to Chief Operating Officer, effective January 1, focusing on operational expertise for its upcoming product approvals. Kern previously served as Senior Vice President of Manufacturing and Operations, significantly contributing to the company's Redwood City facility's readiness. Concurrently, Dr. Julia Haller is stepping down from the Board of Directors, reducing its number of seats to seven. This strategic shift aims to strengthen leadership amidst the anticipated approval of MydCombi, Eyenovia's investigational product for eye dilation.
Eyenovia, Inc. (NASDAQ: EYEN) announced a $15 million credit facility with Avenue Venture Opportunities Fund to support operations, including the anticipated FDA approval of MydCombi™. The initial $10 million is received, with an additional $5 million available upon MydCombi's U.S. approval by August 2023. This financing replaces a previous facility with Silicon Valley Bank, providing a cash balance of approximately $25.5 million. CEO Michael Rowe emphasized minimal dilution compared to equity raises, ensuring operations are funded through late 2023 or early 2024.
Eyenovia, Inc. (Nasdaq: EYEN) announced its participation in the BTIG Ophthalmology Day scheduled for November 29, 2022. The company will showcase its innovative Optejet® delivery system, aimed at treating mydriasis, presbyopia, and pediatric progressive myopia. Management will present from 1:30 to 1:55 PM ET and engage in one-on-one meetings with investors. Eyenovia is focused on late-stage development of microdose array print therapeutics. More details are available on Eyenovia’s corporate website.
Eyenovia, Inc. (Nasdaq: EYEN) announced positive results from the Phase 3 VISION-2 study of MicroLine for presbyopia, meeting primary and secondary endpoints with a significant improvement in visual acuity. The company plans to engage with the FDA on its regulatory path as a drug/device combination. Financial results for Q3 2022 showed a net loss of $7.3 million, up from $5.6 million in Q3 2021. Operating expenses rose 22% year-over-year. Eyenovia ended the quarter with $25.3 million in cash and equivalents. The company emphasizes key milestones expected in 2023.
Eyenovia, Inc. (NASDAQ: EYEN) will release its third-quarter financial results for 2022 on November 10, 2022, after market close. Following this, the company's management will hold a conference call at 4:30 PM ET to discuss the results. Participants can join via phone or a live webcast on the company's investor relations website. Eyenovia focuses on developing ophthalmic therapeutic solutions, specifically using its Optejet® delivery system for microdose array print therapeutics aimed at conditions like mydriasis and presbyopia.
On October 21, 2022, Eyenovia, Inc. (NASDAQ: EYEN) announced its participation at the 2022 American Academy of Optometry’s Annual Meeting from October 26-29, 2022, in San Diego. The company will showcase its Optejet® drug delivery system, presenting a virtual press conference titled Eyenovia - The Optejet® Evolving Drug Delivery to Support Optometric Advancement on October 25, 2022. Additionally, Peter Lam, PhD, will present a paper on Aerial Bioburden Monitoring on October 27. For more details, visit Eyenovia.com.
Eyenovia, Inc. (NASDAQ: EYEN) reported positive findings from its VISION-2 Phase 3 study of MicroLine, a potential treatment for presbyopia, demonstrating significant improvement in near visual acuity. In a modified analysis, subjects treated with MicroLine showed at least a 15-letter improvement in distance corrected near visual acuity versus placebo. All secondary endpoints were also met, with fewer than 3% reporting mild adverse events. Eyenovia plans to meet with the FDA for a potential new drug application submission, aiming to capitalize on the favorable market sentiment towards its Optejet delivery system.
Eyenovia, Inc. (NASDAQ: EYEN) announced the retirement of lead independent director Ken Lee, Jr., effective September 30, 2022. Lee has been a board member since 2018, contributing to the company's strategy leading up to the New Drug Application submission for Mydcombi, an investigational fixed-dose combination product for eye dilation. CEO Michael Rowe and Chairman Dr. Sean Ianchulev expressed gratitude for Lee's contributions and support. Eyenovia focuses on microdose array print therapeutics, with Mydcombi licensed to Arctic Vision for the Greater China and South Korea markets.
Eyenovia, Inc. (Nasdaq: EYEN) has announced its participation in two upcoming healthcare conferences. The R.W. Baird Global Healthcare Conference will occur on September 14, 2022, with a presentation from 10:50 AM to 11:20 AM ET. The Ladenburg Thalmann Healthcare Conference is scheduled for September 29, 2022, with a presentation from 3:30 PM to 3:55 PM ET. Eyenovia is focused on developing advanced therapeutics using its microdose array print (MAP™) technology, targeting mydriasis, presbyopia, and myopia progression.
Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company, announced its participation in several medical meetings in September 2022. Key events include:
- Ophthalmology Futures European Forum on September 15, focusing on the Optejet device.
- The T.H.E. Summit also on September 15, discussing pediatric myopia treatment.
- 40th Congress of ESCRS from September 16-20, presenting on microdose delivery.
- Eyecelerator at AAO on September 29, showcasing the Optejet device.
For more details, visit Eyenovia.com.
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