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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.

Rhea-AI Summary

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.

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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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Eyenovia provides an update on its FDA-approved products Mydcombi and Clobetasol Propionate Ophthalmic Suspension. The company announces positive results from a Phase IV study of Mydcombi, highlighting the efficacy and duration of the lowest deliverable dose. They also plan to present at the ARVO Annual Meeting regarding the benefits of Formosa Pharmaceuticals' APNT technology in improving solubility and bioavailability of ophthalmic medications, particularly with clobetasol propionate ophthalmic suspension 0.05%. Eyenovia aims to launch clobetasol as a complement to Mydcombi, tapping into a market estimated to exceed $1.3 billion annually. The company's innovative Optejet technology and partnership with Formosa Pharmaceuticals showcase their commitment to advancing ophthalmic treatments.
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Eyenovia, Inc. (NASDAQ: EYEN) announces plans to accelerate the development of MicroPine for pediatric progressive myopia, with an interim analysis scheduled for 4Q 2024 and a potential NDA submission to the FDA in 2025. The company is also exploring strategic alternatives to enhance shareholder value, including asset sales, mergers, or other strategic actions. Eyenovia aims to capitalize on the significant market opportunity of pediatric progressive myopia, estimated at $1.8 billion, by leveraging its late-stage MicroPine asset. The company is committed to advancing its commercialization efforts for Mydcombi and preparing for the launch of clobetasol propionate ophthalmic suspension 0.05%. Eyenovia is focused on maximizing value generation while reducing operating expenses and evaluating various strategic options.
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Eyenovia, Inc. (NASDAQ: EYEN) will showcase its commercial products, including Mydcombi™, Avenova®, and Clobetasol Propionate Ophthalmic Suspension 0.05%, at upcoming medical meetings. The company aims to raise awareness of its products and discuss commercial terms, positioning itself as a leading partner in the ophthalmic field. Eyenovia plans to drive sales growth in 2025 through synergistic product offerings and innovative technology.
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Eyenovia, Inc. announces FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative pain and inflammation following ocular surgery. The company reacquired rights to MicroPine for pediatric myopia in the U.S. and Canada. Eyenovia advances commercial operations with Mydcombi™ launch, FDA approval of manufacturing facility, and copromotion agreement.
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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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FAQ

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

The current stock price of Eyenovia (EYEN) is $1.59 as of February 24, 2025.

What is the market cap of Eyenovia (EYEN)?

The market cap of Eyenovia (EYEN) is approximately 3.4M.

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

3.42M
2.08M
9.99%
13.73%
2.49%
Biotechnology
Pharmaceutical Preparations
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United States
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