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 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.
Eyenovia, Inc. (NASDAQ: EYEN) has appointed Dr. Julia Haller, a distinguished ophthalmologist, to its Board of Directors. Dr. Haller's extensive experience as an ophthalmic surgeon and scientist is expected to greatly benefit Eyenovia as it advances its late-stage pipeline focused on ophthalmic treatments. CEO Dr. Sean Ianchulev expressed confidence that Dr. Haller's leadership will enhance the company's goals of achieving clinical and regulatory milestones. Dr. Haller has held significant positions at Wills Eye Hospital and has published over 400 scientific works, reinforcing her reputation in the field.
Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic firm, announced its financial results for Q4 and full year 2020. It reported a net loss of $4.2 million in Q4, an improvement from $5.2 million in Q4 2019. Total revenue for the year was approximately $2.0 million, mainly from a licensing milestone. The FDA has accepted its NDA for MydCombi™, with a PDUFA date set for October 28, 2021. Additionally, patient enrollment in the Phase 3 VISION-1 study is complete, with topline data expected in Q2 2021. The company ended 2020 with $28.4 million in cash.
Eyenovia, Inc. (NASDAQ: EYEN) has partnered with EVERSANA to commercialize MydCombi, a microdosed mydriatic agent, pending FDA approval. This collaboration follows the FDA's acceptance of Eyenovia's New Drug Application for MydCombi, aimed at enhancing pupil dilation efficiency during eye exams. EVERSANA will exclusively distribute MydCombi in the U.S. and assist in establishing an e-commerce platform for sales analytics. Eyenovia anticipates that this partnership will streamline the launch process while keeping costs lower than typical in ophthalmology.
Eyenovia, Inc. (NASDAQ: EYEN) will release its financial results for Q4 and full year 2020 on March 25, 2021, post-market close. The company, focused on ophthalmic therapeutics, will host a conference call at 4:30 PM ET on the same day. Attendees can join via phone or through the company's website. The call will feature insights from key executives, including CEO Dr. Sean Ianchulev. Following the live session, the call will be archived on their website for one year, providing accessible information for investors.
Eyenovia (NASDAQ: EYEN) announced the publication of results from Phase 3 studies demonstrating the safety and efficacy of a micro-dosed tropicamide-phenylephrine fixed combination for pupil dilation. In the trials, 93% of treated eyes achieved 6 mm dilation at 35 minutes compared to lower rates with individual agents. Adverse events were mild in 3% of participants. The FDA has accepted Eyenovia's New Drug Application for MydCombi, with a potential approval date set for Q4 2021. The novel Optejet dispenser offers a touch-free, precise delivery system to enhance patient comfort and reduce medication waste.
Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic company, will participate in the 33rd Annual Roth Conference from March 15-17, 2021. They will host virtual one-on-one meetings to connect with institutional investors. Eyenovia focuses on developing advanced therapeutics utilizing its proprietary microdose array print (MAP™) technology, specifically targeting presbyopia, myopia progression, and mydriasis. For more information, visit www.eyenovia.com.
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