NEW YORK, 08 Feb. 10, 2022 (GLOBE NEWSWIRE) — Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of imprinted microdose therapies (MAP™), today announced that the company has successfully completed a Meeting type A with the United States Food and Drug Administration (FDA) regarding the new NDA filing for MydCombi.
On October 22, 2021, Eyenovia received a Complete Response Letter (CRL) from the FDA indicating that MydCombi, the proprietary and first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation, had been reclassified as a drug- combined product of appliances. Following the recent Type A meeting, Eyenovia and the agency have aligned on the way forward towards a new NDA submission. Specifically, the FDA has asked the company to perform additional testing on Optejet-related devices.® distributer. It is important to note that no additional clinical studies of MydCombi were requested.
“We had a very constructive meeting with the FDA and confirmed the additional non-clinical items to be addressed. We are in the process of conducting these requested validation studies and expect to resubmit our NDA in Q3 2022,” said Sean Ianchulev, CEO and Chief Medical Officer of Eyenovia. “It should be noted that now that our product candidates are classified as combination drug/device products, we will take advantage of this requested validation work to streamline development activities for our future programs. One such potential benefit is the ability to reference this device validation work in future regulatory applications, reducing the time and expense required to repeat this testing for each program.
“Overall, while we certainly would have preferred not to have this delay, we understand the legal necessity of the reclassification. Ultimately, we believe our work today will lay the regulatory foundation for future products.
“Alongside these activities, our second Phase 3 clinical trial VISION-2 of MicroLine, our proprietary formulation of pilocarpine for the temporary improvement of near vision in people with presbyopia, continues to enroll and we expect to publish the results in the second quarter of this year. . We believe the presbyopia market is an addressable market of nearly $8 billion in the United States alone.
The company will detail these and other recent developments during its fourth quarter update conference call in mid-March.
About Optejet® and Microdose Array Print (MAP™) Therapeutic
Eyenovia’s Optejet formulation and microdose delivery platform for ocular therapy uses high-precision piezoelectric printing technology to deliver approximately 8 μL of medication, consistent with the eye’s tear film capacity. We estimate that the volume of ophthalmic solution delivered with the Optejet is less than 20% of that delivered using conventional droppers, reducing overdose and exposure to medications and preservatives. Eyenovia’s patented microfluidic ejection technology is designed for rapid and gentle ocular surface delivery, where the solution is dispensed onto the ocular surface in approximately 80 milliseconds, beating the eye blink reflex. Successful use of the Optejet has been demonstrated over 85% of the time after basic training in a variety of clinical settings, compared to the 40-50% historically seen with conventional droppers. Additionally, its smart electronics and mobile eHealth technology are designed to track and improve patient compliance.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic pharmaceutical technology company developing a portfolio of Microdose Printed (MAP™) therapeutics. Eyenovia is currently focused on the advanced development of microdose drugs for mydriasis, presbyopia and myopia progression. For more information, visit Eyenovia.com.
The Eyenovia Corporate Information slideshow is available at ir.eyenovia.com/events-and-presentations.
Except for historical information, all statements, expectations and assumptions 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 other statements regarding our future business or other future events or conditions, including including estimated market opportunities for our product candidates and platform technology. 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 results may, and in some cases may, differ materially from what is expressed or anticipated in forward-looking statements due to numerous factors discussed from time to time in our filings with the Securities and Exchange. the United States. Committee. In addition, these statements could be affected by risks and uncertainties relating to, among other things, the risks of our clinical trials, including, but not limited to, costs, design, initiation and enrollment ( that may still be adversely affected by COVID-19 and resulting social distancing), the timing, progress and results of such trials; the timing and our ability to submit applications, obtain and maintain regulatory approvals for our product candidates; the potential impacts of COVID-19 on our supply chain; the potential benefits of our product candidates and technology platform; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the use of third parties to develop and commercialize our product candidates; the ability of us and our partners to develop, implement and maintain timely manufacturing, sales and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in the legal, regulatory and legislative environments of the markets in which we operate and the impact of such changes on our ability to obtain regulatory approval for our products; and our competitive position. All forward-looking statements speak only as of the date they are made, and except as required by applicable securities laws, Eyenovia undertakes no obligation to update any forward-looking statements.
Eyenovia Investor Contact:
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Eyenovia media contact:
Vice President, Commercial Operations