Eyenovia Announces Commencement of Manufacturing of its Advanced, Second Generation Optejet Device
Rhea-AI Summary
Eyenovia, Inc. (NASDAQ: EYEN) has begun manufacturing registration batches of its FDA-approved mydriasis product, Mydcombi, using the advanced Gen-2 Optejet dispensing platform. This marks a important step in the approval process for the new device, which is designed for an optimized user experience and extended patent protection through 2041.
The Gen-2 Optejet features improvements such as one-button use and compatibility with Eyenovia's digital compliance monitoring program, Optecare™. The company received feedback from the FDA in July that aligned with their device qualification plan, allowing for efficient progress in manufacturing and testing.
Eyenovia expects to complete testing of Mydcombi registration batches by the end of next year, with a potential SNDA filing in early 2026. The Gen-2 Optejet platform may also provide lower manufacturing costs and streamline future regulatory interactions for additional therapeutics, including those in development partnerships.
Positive
- Commencement of manufacturing registration batches for Mydcombi using Gen-2 Optejet platform
- FDA feedback aligns with company's device qualification plan
- Gen-2 Optejet offers improved user experience and extended patent protection through 2041
- Potential for lower manufacturing costs and streamlined regulatory interactions for future therapeutics
Negative
- SNDA filing for Mydcombi not expected until early 2026
- 12-month stability testing required before potential approval
News Market Reaction – EYEN
On the day this news was published, EYEN declined 2.30%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
The Gen-2 Optejet is designed for an optimized user experience while ensuring extended patent protection for products using the platform through 2041
NEW YORK, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced that the Company has commenced manufacturing of registration batches of its FDA-approved mydriasis product, Mydcombi, a key step in the approval process for its state-of-the-art Gen-2 Optejet dispensing platform.
Mydcombi will undergo 12-month stability testing and other functional testing in the Gen-2 Optejet device that is consistent with feedback from the Type-C meeting on Eyenovia’s device qualification plan that the Company received from the FDA in July.
“We were very pleased to have received feedback from the FDA that was very consistent with our Gen-2 qualification plan, allowing us to move forward with manufacturing and testing as quickly and efficiently as possible,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “With advances from the prior generation product, including one-button use and compatibility with our digital compliance monitoring program, Optecare™, we view the introduction of the Gen-2 Optejet as a significant upcoming inflection point for our company.”
“Importantly, the work that we are doing for Mydcombi in the Gen-2 Optejet device may also provide significantly lower manufacturing costs and streamline future regulatory interactions as we expand the Gen-2 platform to additional therapeutics, both within our own pipeline as well as those in development partnerships, such as dry eye,” Mr. Rowe concluded.
Eyenovia anticipates completion of testing of its Mydcombi registration batches by the end of next year, with a potential SNDA filing in early 2026.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi® for mydriasis, clobetasol propionate ophthalmic suspension,
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray)
PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension
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 estimated market opportunities for our product candidates and platform technology, the impact of the Gen-2 Optejet device, and the timing for availability and sales growth of our approved 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: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; 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 regulatory approval for our products and product candidates; and our competitive position.
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. Andy Jones Chief Financial Officer ajones@eyenovia.com | Eyenovia Investor Contact: Eric Ribner LifeSci Advisors, LLC eric@lifesciadvisors.com (646) 751-4363 | Eyenovia Media Contact: Eyenovia, Inc. Norbert Lowe Vice President, Commercial Operations nlowe@eyenovia.com |
FAQ
What is the latest development for Eyenovia's Mydcombi product?
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