Full Press Release Details
Recent Progress in Three Phase 3 Programs, NDA Review Progress and Licensing Agreements Totaling up to $100 Million in Potential Pre-Commercial
YORK-June 15, 2021-Eyenovia, Inc. (NASDAQ: EYEN), a clinical
stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP ) therapeutics, today provided a
corporate update on its pipeline with recent and upcoming milestones.
announced initial topline data from its Phase 3 VISION-1 clinical trial, which evaluated the company's proprietary pilocarpine
solution, administered via the Optejet , for the treatment of presbyopia. Today, the company is providing additional details from
the study. The VISION-1 study evaluated the safety and efficacy of Eyenovia's MicroLine presbyopia microdose formulations versus
placebo, all administered via the company's proprietary Optejet delivery Micro-Array Print technology.
the 2% MicroLine dose include:
evaluated the safety and efficacy of Eyenovia's 1% and 2% pilocarpine Micro-Array Print (MAP ) formulations versus placebo,
all administered via the company's proprietary Optejet dispenser. VISION-1 is the third Phase 3 study demonstrating the utility
of the company's MAP technology in improving the therapeutic index of topical ophthalmic drugs.
To support the submission
of a New Drug Application (NDA), the company is on track to initiate a second Phase 3 registrational trial, VISION-2, later this year.
VISION-2 will be a double-masked, placebo-controlled, cross-over superiority trial designed to enroll 120 patients randomized between
2% pilocarpine and placebo cohorts. Topline data is anticipated in mid-2022.
It is estimated that
as many as 18 million people between the ages of 40-55 suffer from presbyopia in the U.S. alone, suggesting a multi-billion-dollar addressable
market for MicroLine, if approved.
PDUFA Date Set for October 28, 2021
Eyenovia is developing
MydCombi for pharmacologic mydriasis, a market that the company estimates to be greater than $250 million annually in the U.S. alone.
In March 2021, the U.S. Food and Drug Administration accepted Eyenovia's NDA, which was supported by two successful Phase 3 studies,
MIST-1 and MIST-2. FDA has assigned a PDUFA target action date of October 28, 2021.
If approved, Eyenovia
anticipates marketing MydCombi with a small, targeted sales force. The company has also partnered with EVERSANA, a leading provider of
commercial services to the global life sciences industry, to assist with the launch.
Agreements with Bausch Health and Arctic Vision
disclosed two licensing agreements for its investigational treatment for the reduction of pediatric myopia progression, MicroPine (atropine):
with Arctic Vision for Greater China and Korea, and Bausch Health for the United States and Canada. Eyenovia has the potential to earn
up to $100 million in development milestones over the next four years, as well as significant sales royalties, if approved. Development
is progressing as planned. Eyenovia continues to evaluate potential licensing partners covering other key geographical territories.
the process of assuming responsibilities for the ongoing conduct of the CHAPERONE trial and enrollment is proceeding as planned during
the transition of the program.
Arctic Vision recently
announced completion of over $100 million in Series B financing to support the progress of their pipeline, including MicroLine and MicroPine,
as well as in-house R&D capabilities, business development, and organizational growth.
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.
The Eyenovia Corporate
Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
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 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 (which could still be adversely impacted by COVID-19 and resulting social distancing), timing,
progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory
approvals for our product candidates; 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; reliance on third parties to develop and commercialize our product
candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing
capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory and legislative 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
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.
Chief Financial Officer
LifeSci Advisors, LLC
Pazanga Health Communications