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 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.
Eyenovia, Inc. (NASDAQ: EYEN) will host its Annual Meeting of Stockholders virtually on June 16, 2022, at 10:00 am EDT. Stockholders registered by April 18, 2022, can vote via an online portal until June 15, 2022. It is essential for stockholders to register by 9:45 am EDT on the meeting day. The meeting aims to engage stockholders and encourage them to submit their proxies in advance. Eyenovia focuses on microdose array print (MAP™) therapeutics for various ophthalmic conditions, including presbyopia and myopia progression.
Eyenovia, Inc. (NASDAQ: EYEN) announced its Annual Meeting of Stockholders will be held virtually on June 16, 2022, at 10:00 AM EDT. Stockholders of record as of April 18, 2022, can vote in advance of the meeting. An online portal is available for viewing proxy materials and voting. Registration for the meeting must be completed by 9:45 AM EDT on the day of the meeting. The company focuses on developing microdose array print (MAP™) therapeutics aimed at treating eye conditions such as mydriasis and presbyopia.
Eyenovia, Inc. (NASDAQ: EYEN) announced a leadership transition as CEO Dr. Sean Ianchulev will step down and become non-executive Chairman of the Board. Ianchulev, a co-founder, will retain a consulting role to support ongoing clinical trials. The company is searching for a new CEO to lead it towards commercial growth, especially with upcoming milestones like the Mydcombi NDA re-filing and Phase III studies for its Microline presbyopia program. This transition marks a significant step for Eyenovia as it prepares for the next stage in its development.
Eyenovia, Inc. (NASDAQ: EYEN) reported its Q1 2022 financial results, ending with approximately $34.6 million in cash and cash equivalents. The company is on track for the NDA resubmission of Mydcombi in Q3 2022 and expects topline data from the VISION-2 Phase 3 study for MicroLine by mid-year. The net loss for the quarter was approximately $(7.3) million or $(0.24 per share, a deterioration from a $(5.4) million net loss in Q1 2021. The company has made progress on FDA device validation testing and has launched presbyopia studies demonstrating the efficacy of its Optejet technology.
Eyenovia, Inc. (NASDAQ: EYEN) will release its financial results for Q1 2022 on May 12, 2022, after market close. A conference call is scheduled for 4:30 PM ET the same day, where management will discuss the results. Participants can join the call by dialing 1-877-207-9876 domestically or 1-212-231-2932 internationally, using conference code 22018217. A live webcast will also be accessible on the company's investor relations page, with an archive available for one year.
Eyenovia, Inc. (NASDAQ: EYEN) announced that Dr. Sean Ianchulev will present at the Eyecelerator conference on April 21, 2022, in Washington, DC. The presentation will focus on glaucoma therapies and the innovative Optejet® technology. Dr. Ianchulev emphasized its potential to enhance the effectiveness of current glaucoma treatments. The session titled 'Changing the Way We Look at Glaucoma' will take place from 3:30 PM to 4:14 PM EDT, highlighting the company's mission to improve patient outcomes through advanced ophthalmic solutions.
Eyenovia, Inc. (NASDAQ: EYEN) announced positive results from its "SPEED" study, demonstrating the efficacy of a single microdose array print (MAP™) spray via the proprietary OpteJet® dispenser. Presenting at the American Society of Cataract and Refractive Surgery Annual Meeting, the study showed that nearly 75% of patients achieved clinically meaningful pupil dilation within 15 minutes. The MAP technology was noted for its high success rate (98%) in drug administration without any reported adverse events. This advancement may reduce side effects associated with traditional eye drops.
Eyenovia, Inc. (NASDAQ: EYEN) announced key developments, including a successful Type A meeting with the FDA, setting the stage for the resubmission of the MydCombi NDA in Q3 2022. The company enrolled its first patient in the Phase 3 VISION-2 study for MicroLine, targeting presbyopia treatment. Eyenovia secured a $15 million agreement with Armistice Capital to support clinical and manufacturing efforts. Financially, Q4 2021 net income was $3.0 million, a turnaround from a net loss of $4.2 million in Q4 2020, with total 2021 license revenue reaching $10 million.
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