Eyenovia announces progress on its user-filled Optejet eye drop dispenser, aiming for U.S. regulatory approval in late 2025.
Quiver AI Summary
Eyenovia, Inc. has made significant advancements in the development of its user-filled Optejet® spray dispenser, aimed at improving the administration of ophthalmic medications. The device addresses common issues with traditional eye drops, such as inaccurate dosing and discomfort while providing a reliable and precise delivery system. The new design features a sterile disposable cartridge that users can fill with their own eyedropper bottles, allowing for up to 180 metered sprays. Eyenovia plans to file for U.S. regulatory approval for the Optejet by the fourth quarter of this year, anticipating that it can capture a share of the multi-billion-dollar ophthalmic market. The Optejet is expected to enhance patient experience and treatment compliance, offering potential advantages for chronic eye disease management.
Potential Positives
- Announcement of progress in the development of the Optejet, highlighting the company's commitment to innovative ophthalmic technology.
- Intention to file for U.S. regulatory approval for the Optejet in the fourth quarter of this year, indicating progress towards commercialization.
- The user-filled Optejet addresses significant consumer pain points with traditional eye drops, potentially improving user experience and compliance.
- Potential access to a multi-billion-dollar ophthalmic market, with the Optejet designed for versatile applications across various ophthalmic liquids.
Potential Negatives
- The press release heavily relies on forward-looking statements, which indicates that there are uncertainties and risks regarding the company's future performance and market opportunities.
- The acknowledgment of numerous factors that may lead to actual outcomes differing materially from projections raises concerns about the company's credibility and ability to deliver on promises.
- The company faces potential challenges related to regulatory approvals and reliance on third parties for product development and commercialization, which could hinder progress and market entry.
FAQ
What is the Optejet® device?
The Optejet® is a user-filled spray dispenser designed to improve the administration of ophthalmic medications.
How does the user-filled Optejet work?
Users fill a sterile disposable cartridge with their eyedropper bottle, which attaches to a reusable base for dispensing.
What are the benefits of using the Optejet?
The Optejet enhances user experience by reducing waste, discomfort, and potential side effects associated with traditional eye drops.
Which ophthalmic products can the Optejet dispense?
The Optejet is designed for various topical ophthalmic liquids, including artificial tears and lens rewetting solutions.
When will Eyenovia file for U.S. regulatory approval?
Eyenovia plans to file for U.S. regulatory approval for the Optejet in the fourth quarter of 2025.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$EYEN Insider Trading Activity
$EYEN insiders have traded $EYEN stock on the open market 2 times in the past 6 months. Of those trades, 2 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $EYEN stock by insiders over the last 6 months:
- MICHAEL M ROWE (Chief Executive Officer) has made 2 purchases buying 77,071 shares for an estimated $42,576 and 0 sales.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$EYEN Hedge Fund Activity
We have seen 13 institutional investors add shares of $EYEN stock to their portfolio, and 42 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARMISTICE CAPITAL, LLC added 2,473,741 shares (+40.8%) to their portfolio in Q3 2024, for an estimated $1,277,934
- GOLDMAN SACHS GROUP INC removed 362,183 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $187,103
- JANE STREET GROUP, LLC removed 190,285 shares (-83.3%) from their portfolio in Q3 2024, for an estimated $98,301
- NORTHERN TRUST CORP removed 189,462 shares (-75.5%) from their portfolio in Q3 2024, for an estimated $97,876
- DIAMETRIC CAPITAL, LP added 157,966 shares (+inf%) to their portfolio in Q3 2024, for an estimated $81,605
- GEODE CAPITAL MANAGEMENT, LLC added 149,471 shares (+36.6%) to their portfolio in Q3 2024, for an estimated $77,216
- Y-INTERCEPT (HONG KONG) LTD removed 94,615 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $3,910,248
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
NEW YORK, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”), an ophthalmic technology company focused on completing development of its proprietary Optejet
®
device, today announces recent progress on the development of its user-filled spray dispenser.
“Millions of consumers have difficulty with traditional eye drops, including difficulty with inaccurate administration, discomfort from head tilting, messing up make-up and waste and potential side effects associated with excess drops, all of which could be addressed with the Optejet,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “To that end, we continue to advance development of our novel, user-filled Optejet dispenser and look forward to filing for U.S. regulatory approval for this device in the fourth quarter of this year. We believe the user-filled Optejet can address multi-billion-dollar ophthalmic markets while offering an enhanced user experience.”
Some of the features incorporated into the user-filled Optejet include:
User-Filled Cartridge
The new design includes a sterile disposable cartridge that users can fill using their own, fresh eyedropper bottle. The cartridge is then attached to the reusable base unit and would be capable of dispensing up to 180 metered sprays. Once empty, the cartridge is simply replaced with a new user-filled cartridge.
Reliable and Precise Spray
Rigorous testing has resulted in observations of the Optejet’s durable base unit performing over 30,000 sprays, and 98% of the Optejet sprays were between 8-9 microliters (approximately equal to the amount of liquid the eye can hold) over 180 doses, meeting exacting specifications.
Versatile Applications
The user-filled Optejet is designed to work with a variety of topical ophthalmic liquids, such as artificial tears and lens rewetting products, which are expected to generate sales of four billion dollars in the U.S. this year alone.
About Eyenovia, Inc.
Eyenovia, Inc. is an ophthalmic technology company developing its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet may be especially useful in treatment of chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. For more information, please visit Eyenovia.com.
Forward Looking Statements
Except for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including those relating to the estimated market opportunities for our platform technology and the regulatory pathway and timing for availability of our products. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.
In addition, such statements could be affected by risks and uncertainties related to, among other things: the potential advantages of our products and platform technology; the regulatory pathway that would apply to our products; our estimates regarding the potential market opportunity for our products; reliance on third parties to develop and commercialize our products; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain and maintain regulatory approval for our products and product candidates; our competitive position; our ability to raise additional funds and to make payments on our debt obligations as and when necessary; and our ability to pursue strategic alternatives.
Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.
Eyenovia Contact:
Eyenovia, Inc.
Norbert Lowe
Sr. Vice President, Commercial Operations
admin@eyenovia.com
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/405b239a-8b0f-4d1f-a650-aa6bf45d84e9
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
