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) will announce its fourth quarter and full year financial results for 2022 on March 30, 2023, after market close. Following this release, the company will host a conference call and webcast at 4:30 PM ET to discuss the results. Interested participants can join by dialing either 1-877-407-9039 (domestic) or 1-201-689-8470 (international) using conference code 13736709. A live webcast will also be accessible on their investor relations page. The event will be archived on Eyenovia’s website for one year.
Eyenovia, Inc. (NASDAQ: EYEN) announced the resignation of Stephen Benjamin from its Board of Directors as he takes on the role of Head of the White House’s Office of Public Engagement. Benjamin, who has been a director since February 2022, has significantly contributed to the company during his tenure. Eyenovia's CEO, Michael Rowe, expressed enthusiasm for Benjamin's new position and acknowledged his impact on the company's progress. The Board will maintain seven members and has initiated a search for Benjamin's successor. Eyenovia focuses on developing microdose array print therapeutics aimed at eye conditions.
A collaboration has been announced between Formosa Pharmaceuticals and Eyenovia, Inc. to develop innovative ophthalmic therapies. This partnership will integrate Formosa's APNT™ nanoparticle formulation platform with Eyenovia's Optejet® dispensing technology, aimed at addressing significant unmet medical needs in ophthalmology. Eyenovia's Optejet® utilizes Microdose Array Print (MAP™) technology for precise drug delivery, enhancing patient compliance while minimizing dosage volume. Formosa's APNT™ platform is designed to improve drug dissolution and bioavailability, expanding the potential for new ophthalmic indications. Both companies express optimism about the collaboration's potential.
Eyenovia (NASDAQ: EYEN) announced positive results from a study evaluating its Optejet® delivery system in treating glaucoma. Conducted in collaboration with Tufts Medical Center, the research showed that Optejet reduced pro-inflammatory cytokines compared to standard eye drops containing benzalkonium chloride (BAK). This suggests Optejet may better decrease ocular inflammation, a common issue with BAK-preserved medications. The company continues to focus on developing innovative ocular therapeutics, including its investigational product Mydcombi™ for mydriasis.
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.
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