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) 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.
Eyenovia, Inc. (NASDAQ: EYEN) announced plans to release its second-quarter financial results on August 11, 2021, after market close. This release will be followed by a conference call at 4:30 PM ET, where management will discuss the results. Interested participants can join the call by dialing 855-327-6837 domestically or 631-891-4304 internationally, using conference code 10015927. A live webcast will also be accessible on Eyenovia's investor relations page. The event will be archived for one year on their website.
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company, announced its participation in the Eyecelerator Company Showcase on July 22, 2021. The company will be involved in a panel discussion titled, “Presbyopia: Everybody gets it... but can it be fixed?” The event will occur at Mandalay Bay South Convention Center, Las Vegas, at 2:15 PM PT. Eyenovia has recently completed the Phase 3 VISION-1 study of MicroLine, a treatment aimed at improving near vision in presbyopic patients using its Optejet® dispenser.
Eyenovia, Inc. (NASDAQ: EYEN) announced participation in two upcoming virtual healthcare conferences: the Ladenburg Thalmann 2021 Healthcare Conference on July 14 and the William Blair Biotech Focus Conference 2021 from July 14-15. The company focuses on developing advanced therapeutics through its proprietary MAP™ technology for conditions like presbyopia and myopia progression. Management will provide a corporate overview and engage in one-on-one meetings with investors. For more details, visit their website.
Eyenovia, Inc. (NASDAQ: EYEN) reported positive results from its Phase 3 VISION-1 clinical trial for its pilocarpine solution, MicroLine, aimed at treating presbyopia. Key findings include a statistically significant improvement in near vision over placebo, with 71% of subjects reporting meaningful vision enhancement. Eyenovia plans to initiate a second trial, VISION-2, in 2021 and anticipates making a New Drug Application submission. The FDA has set a PDUFA date of October 28, 2021, for its MydCombi product, while the company also announced licensing agreements for its MicroPine treatment, potentially earning up to $100 million.
Eyenovia, Inc. (NASDAQ: EYEN) announced that its VISION-1 study for the MicroLine pilocarpine formulation aimed at improving near vision in presbyopic adults achieved its primary endpoint. The study demonstrated a significant improvement in near visual acuity compared to placebo, with no serious adverse events reported. Eyenovia is preparing for a second Phase 3 study, VISION-2, and a New Drug Application (NDA) submission. The potential market for MicroLine is substantial, with around 18 million presbyopic individuals in the U.S.
Eyenovia, Inc. (NASDAQ: EYEN) announced key developments on May 12, 2021, including the confirmation of its PDUFA date for MydCombi as October 28, 2021. The company completed patient enrollment in its Phase 3 VISION-1 study for MicroLine, with top-line data expected soon. Financial results showed a net loss of $5.4 million for Q1 2021, slightly reduced from $5.5 million in Q1 2020. Eyenovia secured a $25 million credit facility with Silicon Valley Bank to support ongoing operations.
Eyenovia, Inc. (NASDAQ: EYEN) has secured a $25 million credit financing facility from Silicon Valley Bank. This non-dilutive financing is expected to provide significant operational flexibility, with $7.5 million received at closing and the remaining $17.5 million available upon meeting specific milestones. The funds will support Eyenovia's upcoming Mydcombi launch, the development of MicroLine, and additional ophthalmic indications leveraging their Optejet microdosing technology.
Eyenovia, Inc. (NASDAQ: EYEN) will announce its Q1 2021 financial results on May 12, 2021, after market close. A conference call will follow at 4:30 PM ET, featuring CEO Dr. Sean Ianchulev, COO Michael Rowe, and CFO John Gandolfo. Participants can join by calling 877-407-9039 or 201-689-8470, using conference code 13718776. A live webcast is accessible on Eyenovia's investor relations page and will be archived for one year.
Eyenovia focuses on developing microdose array print (MAP) therapeutics for eye conditions.
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