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 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.
Eyenovia, Inc. (NASDAQ: EYEN) will announce its financial results for Q4 and the full year ended December 31, 2021, on March 28, 2022, after market close. The company plans to host a conference call at 4:30 PM ET on the same day to discuss these results. Participants can join by calling 877-407-9039 (domestic) or 201-689-8470 (international) using conference code 13727374. A live webcast will be available on the company's investor relations website. This event will also be archived for one year.
Eyenovia, Inc. (NASDAQ: EYEN) announced positive results from a study with Tufts Medical Center evaluating its Optejet microdose technology against standard eye drops using Latanoprost + Benzalkonium Chloride (BAK). The study demonstrated that Optejet significantly reduced ocular surface damage compared to traditional methods. This new approach minimizes the toxic effects associated with preservatives found in standard treatments, which is a major concern for patients using long-term ocular therapies for conditions like glaucoma. The findings support the efficacy of Eyenovia's innovative MAP™ therapeutics.
Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company, has announced a Securities Purchase Agreement with Armistice Capital, raising approximately $15 million through the offering of 3 million shares of common stock and warrants. The offering is priced at $3.08 per share, reflecting the market price as of March 3, 2022. The proceeds will support the MydCombi program, enhance manufacturing capabilities, and cover working capital. The offering is scheduled to close around March 7, 2022, pending customary conditions.
Eyenovia, Inc. (NASDAQ: EYEN) announced a successful Type A meeting with the FDA regarding the resubmission of its NDA for MydCombi, a drug-device combination product for pupil dilation. Following a complete response letter in October 2021, the FDA requested additional device testing but no further clinical studies. Eyenovia plans to resubmit the NDA in Q3 2022. The company is also advancing its MicroLine Phase 3 clinical trial for presbyopia, targeting a nearly $8 billion market in the U.S. Further details will be shared during the upcoming quarterly update.
Eyenovia, Inc. (NASDAQ: EYEN) announced significant changes to its Board of Directors. Dr. Sean Ianchulev has been appointed Chairman, while Kenneth Lee, Jr. assumes the role of Lead Director. New members Rachel Jacobson and Stephen Benjamin join the Board, bringing diverse expertise in business development and public sector leadership, respectively. Dr. Ernest Mario has retired from the Board after nearly eight years. The company is focused on the late-stage development of its microdose array print (MAP™) therapeutics for eye conditions.
Eyenovia, Inc. (NASDAQ: EYEN) reported its Q3 2021 financial results, noting a net loss of $5.6 million, or $(0.21) per share, reflecting a slight increase in losses year-over-year. The company has initiated the VISION-2 Phase 3 trial for its MicroLine presbyopia treatment, with data expected mid-2022. Eyenovia anticipates the cash resources of approximately $30 million will cover ongoing projects, including the MydCombi NDA resubmission in early 2022. Dr. Fred Eshelman will step down from the Board by year-end. The company aims for potential milestones in 2022 and 2023.
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