Eyenovia Inc Stock Price, News & Analysis

Eyenovia, Inc. (NASDAQ: EYEN) will showcase its innovative Optejet® drug delivery technology at the 2023 Consumer Electronics Show (CES) in Las Vegas from January 5-8. The booth will highlight the Optejet®'s smart remote patient monitoring features, allowing real-time data transmission to enhance treatment adherence and ophthalmic outcomes. Although the Optejet® is not yet FDA-approved or commercially available, Eyenovia aims to revolutionize topical drug delivery in ophthalmology. CEO Michael Rowe emphasized the potential of this technology in changing current practices in eye care.

Eyenovia, Inc. (NASDAQ: EYEN) announced that the FDA has accepted its New Drug Application (NDA) for MydCombi™, an ophthalmic spray intended for pupil dilation. The FDA set a PDUFA action date for May 8, 2023, without plans for an advisory committee meeting. MydCombi, if approved, would be the first product utilizing Eyenovia's Optejet® drug delivery technology. Additionally, the company received a California Medical Device Manufacturing license, allowing it to begin operations at its new facility in Redwood City.

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.