Eyenovia Announces Commencement of Manufacturing of its Advanced, Second Generation Optejet Device
EYEN 10.01.2024
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- 01.15.2025 - Eyenovia Announces Leading Proxy Advisory Firms, ISS and Glass Lewis, Recommend Eyenovia Stockholders Vote “FOR” Proposed Reverse Stock Split at Upcoming Special Meeting of Stockholders
- 01.06.2025 - Eyenovia Engages Chardan as Advisor for Review of Strategic Alternatives
- 12.06.2024 - Eyenovia, Inc. Announces Pricing of $1.9 Million Registered Direct Offering
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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
“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,”
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The Eyenovia Corporate Information slide deck may be found atir.eyenovia.com/events-and-presentations.
PLEASE GO TOMYDCOMBI.COMFOR IMPORTANT SAFETY INFORMATION for MYDCOMBITM (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
PLEASE GO TOCLOBETASOLBID.COMFOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension 0.05%
Forward-Looking StatementsExcept 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.
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Source: Eyenovia, Inc.