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) and Formosa Pharmaceuticals (TWO:6838) have initiated co-development of clobetasol propionate ophthalmic suspension (0.05%) for treating acute dry eye disease in the U.S. This collaboration expands their existing agreement from February 2023. The product will combine clobetasol propionate, a potent steroid FDA-approved on March 4, 2024, with Eyenovia's Optejet® device.
The U.S. market for topical ocular steroids and steroid combinations is worth approximately $1.3 billion. This new indication could benefit millions experiencing dry eye flare-ups. The companies will share development costs and profits upon commercialization, pending due diligence and a definitive agreement.
Formosa Pharmaceuticals and Eyenovia have announced a collaboration to co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% for the short-term relief of dry eye disease in the United States. This agreement expands their existing partnership from February 2023. Clobetasol propionate, a potent steroid, was FDA-approved on March 4, 2024, for reducing inflammation and pain associated with ocular surgeries. The additional acute dry eye indication could benefit millions experiencing flare-ups, as about 80% of dry eye patients suffer from flare-ups. Formosa's proprietary APNT® nanoparticle formulation platform enhances the drug's bioavailability, while Eyenovia's Optejet® dispenser technology offers advanced delivery. This collaboration aims to address a significant market, with approximately 2 million people in the US treated with prescription medications for dry eye.
Eyenovia (NASDAQ: EYEN) and SGN Nanopharma have announced a collaboration agreement to develop a novel treatment for chronic dry eye disease. The partnership aims to combine SGN's Micellar Nanoparticle Platform (MNP) cyclosporine formulation with Eyenovia's Optejet® dispenser. This collaboration targets the $3 billion U.S. addressable market for dry eye disease, affecting an estimated 35 million people.
Key points:
- SGN's MNP Cyclosporine showed superior results in clinical studies compared to current treatments
- Optejet dispenser delivers medication with 80% less drug volume, potentially improving tolerability
- The companies aim to create a 'best-in-class' therapy for the underserved dry eye market
- They plan to validate manufacturability and consult with the FDA for clinical development
Eyenovia (NASDAQ: EYEN) has entered a collaboration agreement with Senju Pharmaceutical to develop Senju's SJP-0035 for use with Eyenovia's Optejet® dispensing technology as a potential treatment for chronic dry eye disease. The companies plan to meet with the FDA to present a clinical development proposal for a novel drug-device combination product. Dry eye affects nearly 16 million Americans, with treatment costs totaling over $3 billion in the U.S. and $5 billion globally.
SJP-0035 has shown favorable tolerability in prior Phase 1 and 2 studies. The collaboration aims to create a more efficacious and differentiated treatment by integrating SJP-0035 with the Optejet platform. The companies anticipate meeting with the FDA later this year, followed by a Phase 2b study in 2025 and potentially two Phase 3 studies by 2026.
NovaBay Pharmaceuticals and Eyenovia have started joint promotional activities to market NovaBay's Avenova® Antimicrobial Lid & Lash Solution and Eyenovia's MydCombi™ for mydriasis to large ophthalmic surgery centers. Eyenovia's salesforce will promote Avenova, while NovaBay prepares for Eyenovia's upcoming launch of Clobetasol Propionate Ophthalmic Suspension, 0.05% in August 2024. This partnership aims to enhance market presence and awareness for both companies' products, leveraging NovaBay's established network of eyecare professionals. Prescription Avenova is available through EyenoviaRx.com and Avenova.com, with the non-prescription version on Amazon.com.
Eyenovia announced the pricing of a $5 million registered direct offering, involving the sale of 7,575,757 shares of common stock and accompanying warrants. Each share and warrant combination is priced at $0.66, with warrants exercisable at $0.69 per share starting six months from issuance and expiring in 5.5 years. The offering is expected to close around July 1, 2024, subject to customary conditions. Gross proceeds are anticipated to be $5 million before fees and expenses. The funds will support the commercialization of Mydcombi and clobetasol propionate, the CHAPERONE pediatric myopia study, and general corporate purposes, including debt repayment. Chardan is leading the placement, with Brookline Capital Markets acting as co-placement agent.
Eyenovia (NASDAQ: EYEN) reported its Q1 2024 financial results and updates on key products. The company aims to accelerate the development of MicroPine, a late-stage product for pediatric progressive myopia, and anticipates a 3Q 2024 launch for clobetasol propionate ophthalmic suspension, a new steroid for post-ocular surgery inflammation and pain. Additionally, Eyenovia has trained and shipped products to 50 new Mydcombi-using offices since April 2024.
Financially, the company reported a net loss of $10.9 million or $0.23 per share, compared to a $5.7 million loss or $0.15 per share in Q1 2023. Operating expenses increased by 88.1% year-over-year, partly due to reacquiring MicroPine license rights. Eyenovia reduced anticipated cash-based expenses by $0.8 million per quarter and had $8.0 million in cash and equivalents as of March 31, 2024.
The company has completed manufacturing capabilities with FDA approval for three facilities. A conference call and webcast are scheduled for May 15, 2024, at 4:30 pm ET.
Eyenovia (NASDAQ: EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, will report its Q1 2024 financial results on May 15, 2024, after the market closes.
A conference call and webcast will follow at 4:30 p.m. ET to review the financial and operating results. Participants can join the call at 1-800-717-1738 (domestic) or 1-646-307-1865 (international). Live and archived webcasts will be available on the investor relations page of Eyenovia's website.
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