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Eyenovia, Inc. - EYEN STOCK NEWS

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.

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NovaBay Pharmaceuticals, Inc. and Eyenovia, Inc. have signed a co-promotion agreement to commercialize prescription ophthalmic products in the U.S. NovaBay will market Eyenovia's Clobetasol propionate ophthalmic suspension 0.05%, while Eyenovia will market NovaBay's Avenova Antimicrobial Lid & Lash Solution. Clobetasol received FDA approval for post-surgical pain and inflammation treatment, with high success rates. This collaboration aims to leverage both companies' networks for product commercialization and growth.
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Eyenovia, Inc. (EYEN) will release Q4 2023 financial results on March 18, 2024, followed by an investor conference call and webcast. Participants can join the call to review financial and operating results. The event will be accessible via phone and webcast, with a one-year archive available on Eyenovia's website.
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Eyenovia celebrates Formosa Pharmaceuticals' FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain. Eyenovia plans a U.S. launch in the $1.3 billion market with Mydcombi™ sales force. The product offers high efficacy, safety, and convenience with a twice-daily dosing regimen.
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Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate ophthalmic suspension 0.05%, a novel steroid for post-operative ocular surgery. The product shows superior results in Phase 3 trials, targeting a $1.3 billion market.
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Eyenovia, Inc. announces FDA approval for its Redwood City facility in California to manufacture Mydcombi, a unique ophthalmic product. The facility will support the production of the first fixed combination of tropicamide and phenylephrine using Optejet™ technology.
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Eyenovia, Inc. re-acquires the rights to MicroPine in the U.S. and Canada, an investigational ophthalmic spray for pediatric progressive myopia. This acquisition expands Eyenovia's phase III pipeline and commercial opportunities, complementing its commercial-stage asset, Mydcombi, and pre-PDUFA candidate, APP13007. The market for pediatric progressive myopia is estimated to be nearly $2 billion annually in the U.S. The re-acquisition aims to expedite commercialization of advanced products using the Optejet device, providing a significant asset value increase compared to the original license agreement. The company plans to accelerate the ongoing CHAPERONE phase III trial and engage with FDA to explore options to expedite development and registration of MicroPine. Eyenovia will pay Bausch + Lomb Ireland Limited an upfront payment consisting of $2 million in cash and $3 million in shares of common stock, as well as a low single-digit royalty on Eyenovia’s net sales of MicroPine in the United States and Canada.
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Eyenovia, Inc. (NASDAQ: EYEN) Acquires U.S. Commercial Rights to APP13007 from Formosa Pharmaceuticals and Announces FDA Approval of Coastline International as Contract Manufacturer for Mydcombi Cartridge Subassemblies. The company also reported its financial and operating results for the third quarter of 2023. The acquisition of APP13007, currently under FDA review, aims to complement Eyenovia's commercially approved mydriasis product, Mydcombi, potentially generating additional near-term revenue. The company also appointed Mr. Michael Geltzeiler as an independent director and Chair of the Audit Committee. FDA approval of Coastline International as a contract manufacturer for Mydcombi cartridge subassemblies enables a national launch in early 2024. Eyenovia is also advancing its Gen-2 Optejet device and continues to validate its manufacturing facilities in preparation for future commercial use.
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Eyenovia, Inc. (NASDAQ: EYEN) will release its financial results for the third quarter ended September 30, 2023, on November 13, 2023. The company will host an investor conference call and webcast at 4:30 p.m. EDT to review the financial and operating results. Eyenovia is an ophthalmic technology company commercializing Mydcombi™ for mydriasis and preparing for regulatory approval of APP13007 for relief of pain and inflammation post ocular surgery. They are also incorporating their advanced Optejet® device with late-stage product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications.
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Eyenovia, Inc. has received FDA approval for its Supplemental New Drug Application (sNDA), adding Coastline International as a contract manufacturer. Coastline will manufacture cartridge subassemblies for Mydcombi, an FDA-approved tropicamide and phenylephrine hydrochloride fixed combination for mydriasis. Eyenovia anticipates initiating commercial production soon and aims to have the product available to ship in January 2024.
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Eyenovia, Inc. is sponsoring a course at the International Joint Commission on Allied Health Personnel in Ophthalmology (IJCAHPO) 51st Annual Continuing Education (ACE) program. The course will provide ophthalmic technicians with training on the use of Mydcombi™ for mydriasis and background on the Optejet dispensing technology. Eyenovia plans to launch Mydcombi commercially in early 2024.
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FAQ

What is the current stock price of Eyenovia (EYEN)?

The current stock price of Eyenovia (EYEN) is $0.1076 as of November 22, 2024.

What is the market cap of Eyenovia (EYEN)?

The market cap of Eyenovia (EYEN) is approximately 9.0M.

What does Eyenovia, Inc. specialize in?

Eyenovia, Inc. specializes in developing and commercializing next-generation topical eye treatments using its proprietary Microdose Array Print (MAP) platform technology.

What is the Optejet technology?

The Optejet technology is Eyenovia’s high-precision ocular delivery system designed to improve safety, tolerability, and patient compliance for ophthalmic medications.

What are Eyenovia's main products?

Eyenovia's main products include Mydcombi™ (tropicamide and phenylephrine ophthalmic spray) for mydriasis and clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain.

What recent FDA approval has Eyenovia received?

Eyenovia recently received FDA approval for clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid in over 15 years.

What are Eyenovia's key projects in development?

Key projects in development include MicroPine for myopia progression and Apersure for presbyopia, both utilizing the Optejet delivery system.

Who are some of Eyenovia's strategic partners?

Eyenovia has strategic partnerships with companies like Arctic Vision, Formosa Pharmaceuticals, and AimMax Therapeutics.

How does Eyenovia engage with the ophthalmic community?

Eyenovia engages with the ophthalmic community through participation in medical and commercial meetings such as ASCRS and Vision Source Exchange.

What market opportunities is Eyenovia pursuing?

Eyenovia is pursuing market opportunities in the $1.3 billion annual market for topical ophthalmic steroids and the $3.6 billion market for dry eye treatments.

What is Eyenovia's long-term strategic approach?

Eyenovia's long-term strategic approach includes exploring strategic alternatives like mergers or acquisitions and partnerships to maximize shareholder value.

Where can I find more information about Eyenovia?

More information about Eyenovia can be found on their corporate website and investor relations page.

Eyenovia, Inc.

Nasdaq:EYEN

EYEN Rankings

EYEN Stock Data

9.00M
77.81M
9.99%
13.73%
2.49%
Biotechnology
Pharmaceutical Preparations
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United States of America
NEW YORK