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), 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.
Eyenovia, Inc. (NASDAQ: EYEN) announced that CEO Dr. Sean Ianchulev will discuss future treatment options for myopia, including MicroPine (atropine ophthalmic spray), at the Eyecelerator@AAO Meeting. The panel, titled Myopia Control: Corrective Lenses, Drugs and Diagnostics, will take place on November 11, 2021, at the Ernest N. Morial Convention Center in New Orleans, LA, starting at 3:00 PM CT. The Eyecelerator initiative aims to foster collaboration in ophthalmic innovation, enhancing patient care.
Eyenovia, Inc. (NASDAQ: EYEN) is set to announce its financial results for Q3 2021 on November 11, 2021, after market close. Following this, a conference call will be held at 5:00 PM ET to discuss the results and provide a business update. Participants can join the call by dialing 877-407-9039 domestically or 201-689-8470 internationally. A live webcast will also be available on Eyenovia's investor relations website. The event will be archived for one year.
Eyenovia, Inc. (NASDAQ: EYEN) announced the enrollment of the first patient in its second Phase 3 trial, VISION-2, for MicroLine, a pilocarpine formulation aimed at improving near vision in presbyopia. Following the successful VISION-1 trial, which showed MicroLine's superiority over placebo, the new trial will enroll around 140 subjects to measure its effectiveness in low light conditions. The presbyopia market in the U.S. is projected to exceed several billion dollars, indicating significant growth potential for MicroLine pending successful clinical outcomes.
Eyenovia, Inc. (NASDAQ: EYEN) announced the reclassification of its MydCombi product as a drug-device combination by the FDA, following a Complete Response Letter (CRL) received on October 22, 2021. The CRL requests additional information related to the Genus Medical Technologies case, prompting an agency-wide reclassification. Eyenovia plans to expedite its NDA resubmission by early 2022 and notes that its current cash balance of approximately $30.7 million is sufficient for ongoing activities. The Phase III clinical program for MydCombi remains unaffected.
Eyenovia announced positive topline data from its Phase 3 VISION-1 trial evaluating MicroLine for presbyopia, demonstrating a 7.7-fold improvement in near vision over placebo. The company is set to launch a second Phase 3 trial, VISION-2, by year-end 2021. MydCombi's PDUFA date is confirmed for October 28, 2021. Financially, the company reported a net loss of $4.8 million for Q2 2021, with operating expenses up 19% year-over-year. Cash balance stands at approximately $27.2 million, including funding from a credit facility. Earnings call scheduled for August 11, 2021.
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