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) 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.
Eyenovia, Inc. (Nasdaq: EYEN) announced Michael Rowe as the new Chief Executive Officer, replacing Dr. Sean Ianchulev. The company is on track to resubmit the New Drug Application (NDA) for Mydcombi™ in Q4 2022, following the resolution of supply chain issues. The Phase 3 VISION-2 study for MicroLine is progressing, with topline data expected in Q3 2022. Financially, Eyenovia reported a net loss of approximately $(7.2) million for Q2 2022, up from $(4.8) million a year earlier. Cash and equivalents stand at approximately $29.4 million.
Eyenovia, Inc. (NASDAQ: EYEN) announced plans to release its second quarter financial results for 2022 on August 10, after market close. The results will be followed by a conference call at 4:30 PM ET, where management will discuss financial and operational performance. Participants can join via phone or through a live webcast available on the company's investor relations page. The event will be archived on Eyenovia's website for one year, allowing investors to access the information at their convenience.
Eyenovia, Inc. has appointed Michael Rowe as its new CEO, effective August 1, 2022. Rowe, previously the Chief Operating Officer, brings extensive experience in the ophthalmic industry, having been instrumental in the company’s operations and product development. The transition follows Dr. Sean Ianchulev's move to Chairman. Eyenovia expects significant developments, including the potential approval of MydCombi and the progress of strategic partnerships with Bausch+Lomb and Arctic Vision. Rowe’s leadership is anticipated to enhance company momentum towards commercial-stage operations.
Eyenovia announced the operational launch of its new manufacturing facility in Redwood City, CA, enhancing internal capabilities for Optejet manufacturing, including drug loading and packaging. This facility aims to complement existing contract manufacturing partnerships. Additionally, Bren Kern has been appointed as Senior Vice President of Manufacturing and Operations, expected to strengthen the team's efforts in product commercialization. The company reaffirmed timelines for the VISION-2 Phase 3 trial of MicroLine, anticipating topline data in Q3 2022, with significant market interest in their technology.
Eyenovia, Inc. (Nasdaq: EYEN) has announced the appointments of Dr. Ellen Strahlman and Dr. Ram Palanki as independent members of its Board of Directors, expanding the board from six to eight members. Dr. Strahlman brings extensive experience from roles at Becton, Dickinson and Company and GlaxoSmithKline, while Dr. Palanki has significant expertise in commercial strategy in biopharmaceuticals. The CEO expressed confidence that their expertise will enhance the company's leadership as it approaches crucial clinical and regulatory milestones.
Eyenovia (NASDAQ: EYEN) announced that Arctic Vision has enrolled its first patient in a Phase 3 clinical trial for ARVN003 (MicroLine), a pharmacologic treatment for presbyopia, marking a significant milestone in China. This trial is notable as it's the first of its kind in the country, validated by the exclusive licensing agreement between Eyenovia and Arctic Vision signed in August 2020. The partnership also includes Eyenovia's candidates, MicroPine for pediatric myopia and MydCombi for pharmacologic mydriasis, further targeting unmet medical needs in the region.
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