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 announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% (Clobetasol) for treating post-operative inflammation and pain following ocular surgery. As the first new ophthalmic steroid approved in over 15 years, Clobetasol offers a twice-daily dosing regimen and streamlined distribution to eliminate insurance complications.
Recent market research involving 100 ophthalmic surgeons revealed strong interest in Clobetasol. Key findings include:
- Efficacy ranked as the most important characteristic, with ~80% of patients experiencing complete pain relief within four days post-surgery
- Safety profile was highlighted, with no single adverse event affecting more than 2% of patients
- 53% of respondents cited managed care hurdles as a significant issue, which Clobetasol's fixed-price model aims to address
Formosa Pharmaceuticals (6838.TW) has made its first shipment of APP13007 (Clobetasol Propionate Ophthalmic Suspension, 0.05%) to the United States for commercialization. The drug, developed using Formosa's APNT® nanotechnology platform, is the first FDA-approved ophthalmic use of the super-potent corticosteroid, clobetasol propionate. Eyenovia (NASDAQ: EYEN), Formosa's U.S. partner, is set to begin commercialization in late September.
APP13007 offers a more convenient dosing regimen with twice-daily administration, compared to other treatments requiring up to four doses per day. The ophthalmic steroid market is valued at $1.3 billion, with nearly 7 million ophthalmic surgeries performed annually in the U.S. Formosa is also preparing for regulatory submissions in other regions to expand its international market presence.
Eyenovia (NASDAQ: EYEN) has announced that its partner, Formosa Pharmaceuticals, received a Taiwan Export License for clobetasol propionate ophthalmic suspension 0.05%. This approval allows for shipment of the product to the U.S., with a planned launch in late September 2024. Clobetasol is a powerful steroid for reducing inflammation and pain after ocular surgeries, entering a $1.3 billion market for topical ocular steroids. Clinical studies showed that 80% of patients experienced rapid relief from postsurgical pain within four days, and 60% achieved total resolution of inflammation within 15 days. Eyenovia plans to offer competitive pricing to enhance affordability for all patients.
Eyenovia Inc (NASDAQ: EYEN), a commercial-stage ophthalmic company, has appointed Andrew Jones as its new Chief Financial Officer. Jones brings over 30 years of finance and accounting leadership experience in therapeutics and medical technology. He replaces John Gandolfo, who is retiring but will remain with the company through November to ensure a smooth transition.
Jones previously served as CFO of NovaBay Pharmaceuticals, another publicly traded ophthalmic company. His appointment comes at a important time for Eyenovia, which is approaching a critical data readout for MicroPine, launching clobetasol in the U.S., and ramping up commercial efforts for Mydcombi. The company believes Jones' experience in operations and capital raising will position it for long-term success.
Eyenovia, Inc. (NASDAQ: EYEN) has successfully closed its public offering of 12,850,000 shares of common stock at $0.40 per share, raising approximately $5.14 million in gross proceeds. The company plans to use the funds for commercializing Mydcombi and clobetasol propionate, completing the CHAPERONE pediatric myopia clinical study, and for working capital and general corporate purposes, including potential debt repayment. Dawson James Securities, Inc. acted as the placement agent for the offering, which was conducted under Eyenovia's previously filed shelf registration statement.
Eyenovia (NASDAQ: EYEN), a commercial-stage ophthalmic company, has announced the pricing of a $5.14 million public offering. The company will sell 12,850,000 shares of common stock at $0.40 per share, with the closing expected on August 22, 2024. Dawson James Securities, Inc. is acting as the placement agent. Eyenovia plans to use the net proceeds to fund commercialization activities for Mydcombi and clobetasol propionate, complete the CHAPERONE pediatric myopia clinical study, and for working capital and general corporate purposes, including potential repayment of existing debt. The offering is made pursuant to Eyenovia's previously filed shelf registration statement on Form S-3.
Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, has announced its intention to offer and sell shares of common stock (or pre-funded warrants) in a best efforts public offering. The offering's size and terms are subject to market conditions. Eyenovia plans to use the net proceeds for:
- Commercialization of Mydcombi and clobetasol propionate
- Completion of the CHAPERONE pediatric myopia clinical study
- Working capital and general corporate purposes
- Potential repayment of existing debt
Dawson James Securities, Inc. is acting as the sole placement agent. The offering is being made through a shelf registration statement and will be available via a prospectus supplement and accompanying prospectus.
Eyenovia Inc. (NASDAQ: EYEN), an ophthalmic technology company, announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on August 15th, 2024. The company's pre-recorded presentation will be available on-demand starting at 7:00 am EDT on the conference day.
Eyenovia is known for commercializing Mydcombi™, an ophthalmic spray for mydriasis, and clobetasol propionate ophthalmic suspension for postsurgical inflammation and pain. They are also developing the Optejet® device for pediatric progressive myopia and dry eye treatments, with potential for out-licensing in additional indications.
Investors and interested parties can access the presentation by registering for the conference. Virtual 1x1 meetings with Eyenovia management can be arranged through H.C. Wainwright representatives.
Eyenovia Inc (NASDAQ: EYEN) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Plans for validation of the Gen-2 Optejet® device with 2025 regulatory submission for Mydcombi™.
2. Advancement of Phase 3 CHAPERONE study for MicroPine in pediatric progressive myopia.
3. Collaboration agreements with Formosa, Senju, and SGN for dry eye disease treatments.
4. Expanded Mydcombi sales to 63 new offices in Q2, targeting 263 by Q3 end.
Financially, Eyenovia reported a net loss of $11.1 million ($0.21 per share) for Q2 2024, compared to $6.2 million ($0.16 per share) in Q2 2023. The company had $2.3 million in cash as of June 30, 2024, excluding $5.8 million from subsequent equity offerings.
Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, has announced its plans to release financial results for the second quarter ended June 30, 2024 on Monday, August 12th, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results.
Investors can participate by dialing 1-877-407-9039 (domestic) or 1-201-689-8470 (international) with Conference ID# 13747356. A live webcast will be available on the company's website, and the event will be archived for one year after the live webcast.
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