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 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.
Eyenovia, Inc. (NASDAQ: EYEN) announced the acceptance of its New Drug Application (NDA) by the FDA for MydCombi™, a new mydriatic agent aimed at enhancing pupil dilation during eye exams. The product, utilizing the innovative Optejet® delivery system, could potentially address patient discomfort associated with traditional dilation methods. If approved, MydCombi would be the first of its kind to offer a microdosed solution. Phase 3 trials showed safety and efficacy, with 94% of eyes achieving significant dilation. The PDUFA date is set for Q4 2023.
Eyenovia, Inc. (NASDAQ: EYEN) will host a KOL webinar titled “Presbyopia in Focus: Unlocking One of the Biggest Market Opportunities in Ophthalmology” on February 22, 2021, at 1:00 PM ET. Key speakers include Dr. David F. Chang and Dr. Sean Ianchulev, discussing presbyopia treatment and Eyenovia's MicroLine technology, as the condition affects approximately 113 million people in the U.S. Eyenovia is evaluating MicroLine in two Phase 3 studies, VISION-1 and VISION-2, with results expected in mid-2021. The webinar will include a Q&A session.
Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic biopharmaceutical company, announced that Dr. David Wirta will present at the Ophthalmology Innovation Summit Presbyopia Innovation Showcase on January 28th. His talk will address the challenges faced by presbyopia patients and discuss the advantages of using Eyenovia's pilocarpine via the novel Optejet® dispenser. Currently, Eyenovia is assessing its MicroLine formulation in two Phase 3 studies, VISION-1 and VISION-2, which began enrollment in December 2020. These innovations aim to improve the quality of life for the 113 million Americans affected by presbyopia.
Eyenovia, Inc. (NASDAQ: EYEN) announced that Dr. Sean Ianchulev will participate in a panel discussion on presbyopia at the LifeSci Partners 10th Annual Corporate Access Event on January 8, 2021. Eyenovia is developing MicroLine, a proprietary pilocarpine formulation aimed at improving near vision in patients with presbyopia, with top-line results expected in the first half of 2021. Currently, there are no FDA-approved pharmacologic therapies for presbyopia, affecting around 113 million Americans. The panel is titled 'The First Drugs for Far-Sightedness are Near.'
Eyenovia, Inc. (NASDAQ: EYEN) has submitted a New Drug Application (NDA) to the FDA for MydCombi™, a first-of-its-kind microdosed mydriatic agent. This submission follows the initial enrollment in the Phase 3 VISION-1 study for MicroLine aimed at addressing presbyopia, with data expected in early 2021. MydCombi aims to enhance pupil dilation efficiency during eye exams, reducing patient discomfort and exam duration with its innovative Optejet® dispenser. Phase 3 studies demonstrated a 94% dilation success rate, with adverse events reported at a low 3.1%. Approval could launch MydCombi by late 2021 or early 2022.
Eyenovia, Inc. (NASDAQ: EYEN) has announced patient enrollment for its Phase 3 VISION-1 study of MicroLine, a proprietary pilocarpine formulation aimed at improving near vision in presbyopia patients. This condition, affecting around 113 million Americans over 40, typically requires corrective eyewear. The trial aims for quick enrollment and topline data in the first half of 2021, despite potential COVID-19 impacts. The primary endpoint will assess same-day improvements in near visual acuity.
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