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 (NASDAQ: EYEN) announced progress on its user-filled Optejet® spray dispenser, planning U.S. regulatory submission in Q4 2025. The device aims to address common issues with traditional eye drops, including inaccurate administration and discomfort.
Key features of the next-generation Optejet include: a sterile disposable cartridge that users can fill from their eyedropper bottle, capable of 180 metered sprays; demonstrated durability with the base unit performing over 30,000 sprays; and 98% spray accuracy between 8-9 microliters. The device is designed for various topical ophthalmic liquids, targeting the artificial tears and lens rewetting market, expected to reach $4 billion in U.S. sales this year.
Eyenovia (NASDAQ: EYEN) has announced a 1-for-80 reverse stock split, effective January 31, 2025, to regain compliance with Nasdaq's minimum bid price requirement. The split will reduce outstanding shares from approximately 167.5 million to 2.1 million, with trading under the existing symbol 'EYEN' beginning on February 3, 2025.
The reverse split will not affect stockholders' percentage ownership interests, except for cash payments made in lieu of fractional shares. Proportionate adjustments will be made to outstanding stock options, warrants, and shares issuable under the company's 2018 Omnibus Stock Incentive Plan. The authorized share count and par value will remain unchanged.
Eyenovia (NASDAQ: EYEN) has engaged Chardan as financial advisor to evaluate strategic alternatives, including potential business combinations, company sale, reverse merger, or asset sale. The company is simultaneously focusing on developing its Gen-2 user-filled Optejet® device by Q3 2025 while implementing cost reduction measures of over 60%.
The company is exploring two paths for the Optejet device: a consumer 'user-filled' product through a device regulatory pathway without clinical trials, potentially available by end of year, and a proprietary drug-device combination. Eyenovia has not set a timeline for concluding the strategic review and has made no specific decisions regarding alternatives.
Eyenovia (NASDAQ: EYEN) has announced a $1.9 million registered direct offering of 20,085,025 shares of common stock (or equivalents) and warrants to purchase up to 40,170,050 shares. The combined offering price is $0.0969 per share and accompanying warrants. The warrants, exercisable at $0.0969 per share, will be valid for five years starting six months after issuance. Net proceeds will fund working capital, general corporate purposes, partial loan repayment to Avenue Capital Management, advancement of next-generation Optejet device, commercialization of Mydcombi and clobetasol propionate, and exploration of strategic alternatives. The offering is expected to close around December 9, 2024, with Chardan acting as sole placement agent.
Eyenovia (NASDAQ: EYEN) has announced a $1.3 million registered direct offering, pricing 12,081,785 shares of common stock and warrants to purchase up to 24,163,570 shares at $0.1076 per share and accompanying warrants. The warrants will be exercisable after six months at $0.1076 per share and expire five years from initial exercise date. The offering is expected to close around November 26, 2024. Net proceeds will fund working capital, general corporate purposes, potential loan repayment, advancement of Optejet device, commercialization of Mydcombi and clobetasol propionate, and exploration of strategic alternatives. Chardan is the sole placement agent.
Eyenovia (NASDAQ: EYEN) has secured an agreement with Avenue Capital Management to defer principal and interest payments on its outstanding debt until February 2025. The ophthalmic technology company is implementing additional restructuring measures, including a reduction in personnel-related costs by over 70%. The company is exploring various strategic alternatives, which may include a business combination, reverse merger, or asset sales, to maximize stakeholder value.
Eyenovia (NASDAQ: EYEN) announced that its Phase 3 CHAPERONE study evaluating low-dose atropine in the Optejet platform for pediatric progressive myopia is not meeting its primary endpoint. The independent Data Review Committee found no significant difference in myopia progression between treatment arms (0.01% and 0.1% atropine) and placebo among 252 evaluable patients. The primary endpoint targeted less than 0.5 diopter progression in visual acuity over three years. While safety analysis showed all dosages were well-tolerated, the company plans to terminate the study and is considering strategic options including business combination, reverse merger, or asset sales.
Eyenovia (NASDAQ: EYEN) reported Q3 2024 financial results and corporate updates. Key developments include the U.S. launch of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation, advancement of Phase 3 CHAPERONE study for MicroPine in pediatric myopia, and commencement of Mydcombi registration batches in second-generation Optejet device. The company reported a net loss of $7.9 million ($0.11 per share) compared to $7.3 million in Q3 2023. Operating expenses increased 10.6% to $7.2 million. Cash position stood at $7.2 million, with $10.7 million raised in combined net proceeds. The company expanded Mydcombi's reach to 230 new offices from April through September 2024.
Eyenovia (NASDAQ: EYEN), an ophthalmic technology company focused on its proprietary Optejet medication dispensing platform, will release its Q3 2024 financial results on Tuesday, November 12th, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET to discuss the results. Investors can join via phone (1-877-407-9039 domestic, 1-201-689-8470 international) or through the company's website. The webcast will be archived for one year on Eyenovia's website.
Eyenovia (NASDAQ: EYEN) announced two significant developments for its Optejet® dispenser. A study published in the Journal of Ocular Pharmacology and Therapeutics demonstrated that Optejet can deliver latanoprost with significantly less exposure to harmful preservatives compared to traditional eye drops, avoiding cytotoxicity associated with larger volumes. Additionally, a Phase 4 study of Mydcombi, presented at the American Academy of Optometry, showed that a half-dose achieved clinically relevant pupil dilation with favorable safety outcomes. The study reported mean pupil diameter changes from 2.74mm at baseline to 6.42mm after 30 minutes, with 67% of eyes dilated to ≥6mm.
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