NEW YORK & CHICAGO--(BUSINESS WIRE)--Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary Microdose Array Print (MAP™) platform technology, and EVERSANA™, the pioneer of next-generation commercial services to the global life sciences industry, today announced a partnership to help commercialize MydCombi in the United States, if approved.
This announcement follows the U.S. Food and Drug Administration’s recent acceptance of Eyenovia’s New Drug Application (NDA) for MydCombi, a fixed combination mydriatic (pupil dilation) agent for potential use in the over 80 million comprehensive eye exams conducted each year in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet®. The expected PDUFA date for the potential approval of MydCombi is in the fourth quarter of 2021.
If MydCombi is approved, EVERSANA will serve as Eyenovia’s exclusive distributor for all customers in the United States, responsible for accepting and managing orders, payments and shipping of MydCombi to eye care offices throughout the United States. Additionally, EVERSANA will help realize Eyenovia’s strategic commercial strategy by establishing an Eyenovia e-commerce platform to collect and analyze sales data and provide relevant analytics.
“Eyenovia is striving to make the MydCombi launch efficient and seamless for its eye care provider customers,” said Michael Rowe, Chief Operating Officer at Eyenovia. “EVERSANA has an exemplary track record for customer service and commercial excellence. Through this partnership, launch and distribution activities that would typically require an infrastructure build will be managed by EVERSANA, a strategy we anticipate will keep costs well below what is typical in ophthalmology.”
MydCombi was developed to address several challenges eye care practitioners and their patients face related to pupil dilation. The current standard of care for pupil dilation requires multiple eye drops including a topical anesthetic, given at least several minutes apart, which can take considerable time and often cause both discomfort and drug overflow. The design of eyedroppers also lends itself to the possibility of inadvertent contact with the eye itself, which may be an issue, as the same eyedropper bottle is often shared among a number of patients. In contrast, MydCombi is delivered by Eyenovia’s proprietary Optejet dispenser, designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application. The product is designed with no protruding parts, which may help prevent accidental touching of the ocular surface.
“We believe in MydCombi’s potential to provide patients clinical benefits and a more comfortable experience during eye exams,” said Jim Lang, Chief Executive Officer of EVERSANA. “With this collaboration, we look forward to contributing our expertise for a successful launch and roll out of this valuable product to Eyenovia’s customers.”
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, visit www.eyenovia.com.
EVERSANA™ is the leading provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life science solutions for a healthier world.
Eyenovia, Inc. Forward-Looking Statements
Except for historical information, all of 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. 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 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: reliance on third parties; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for certain of our product candidates; the timing and our and our licensees’ ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our and our licensees’ ability to obtain regulatory approval for our products; risks of our and our licensees’ clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social distancing), timing, progress and results of such trials; the potential impacts of COVID-19 on our supply chain; the potential advantages of our product candidates and platform technology; 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; intellectual property risks; 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.