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 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.
Eyenovia, Inc. (NASDAQ: EYEN) announced that the U.S. FDA has accepted its IND application for MicroLine, a pilocarpine formulation aimed at enhancing near vision in presbyopia patients. The company plans to initiate the Phase 3 VISION program, starting with the VISION-1 study later this month. Presbyopia affects around 113 million Americans, with MicroLine offering a microdosed alternative to traditional eye drops using the Optejet® dispenser for precise dosing. The VISION trials will focus on assessing the effectiveness of MicroLine in adults aged 40-60 with presbyopia.
Eyenovia, Inc. (NASDAQ: EYEN) reported its third quarter 2020 results, highlighting key advancements in its ophthalmic portfolio. The company secured a $10 million upfront payment from Bausch Health for licensing MicroPine, with potential milestone payments of up to $35 million. Eyenovia aims to file an NDA for Mydcombi by year-end, with significant potential in treating presbyopia, affecting over 100 million Americans. The company maintains a strong cash position of approximately $31 million after recent funding efforts, including a public stock offering that generated $12.5 million.
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company, will announce its Q3 2020 financial results on November 10, 2020, after market close. This will be followed by a conference call at 4:30 PM ET, featuring CEO Dr. Sean Ianchulev, CFO John Gandolfo, and VP Michael Rowe. Interested parties can join by calling 877-407-9039 or 201-689-8470 (international) with conference code 13713084. A webcast will also be accessible on the investor relations page of Eyenovia's website, where the event will be archived for one year.
Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic biopharmaceutical company, is reaffirming its near-term milestones for the Mydcombi™ NDA and the MicroLine presbyopia program Phase III results. On October 12, 2020, Eyenovia announced a licensing agreement with Bausch Health for the exclusive rights to develop MicroPine in the U.S. and Canada, with potential revenues of up to $45 million. Meanwhile, Arctic Vision acquired exclusive rights for MicroPine and MicroLine in Greater China and South Korea. The company also plans to hold a conference call today at 4:30 PM ET to discuss these developments.
Eyenovia, Inc. (NASDAQ: EYEN) announced upcoming presentations on their clinical trials at the American Academy of Optometry Academy 2020 event. Dr. April Jasper will present updates on the CHAPERONE and VISION studies, focusing on low-dose atropine and pilocarpine for myopia and near vision improvement, respectively. Dr. Siddarth Rathi will discuss results from the MIST studies, evaluating a microdose formulation for pupil dilation. Eyenovia's innovative microdose array print (MAP™) therapeutics aim to enhance treatment efficacy for various ophthalmic conditions.
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company, will present at the 22nd Annual H.C. Wainwright Global Investment Conference from September 14-16, 2020. The presentation will be delivered by Dr. Sean Ianchulev, CEO, and John Gandolfo, CFO, on September 15, 2020, from 2:30 to 2:50 PM ET. Eyenovia focuses on developing microdose array print (MAP™) therapeutics targeting presbyopia, myopia progression, and mydriasis. For more details, visit www.eyenovia.com.
Eyenovia, Inc. (NASDAQ: EYEN) announced the successful closing of an underwritten public offering of 3,333,334 shares at $3.60 per share, raising approximately $10.9 million in net proceeds. The funds will be utilized for the clinical development of product candidates, initial commercialization of MicroStat, and general corporate purposes. The offering was conducted under a shelf registration statement effective since February 12, 2019. William Blair & Company served as the book-running manager, with National Securities Corporation as the co-manager.
Eyenovia, Inc. (NASDAQ: EYEN) announced the pricing of a public offering of 3,333,334 shares at $3.60 each, expected to close on August 21, 2020. The offering could yield around $12 million in gross proceeds, intended for clinical development, MicroStat commercialization, and general corporate purposes. Underwriters have a 30-day option to purchase an additional 500,000 shares. This offering is made under an SEC shelf registration statement effective since February 2019.
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