Eyenovia Announces First Patient Enrolled in MicroLine’s Phase 3 VISION-2 Presbyopia Trial – Form 8-K



Eyenovia Announces First Patient Enrolled in MicroLine Phase 3 VISION-2 Trial for Presbyopia

Vision-2 follows successful Vision-1 trial with first results expected in Q2 2022

Presbyopia is a multi-billion dollar market opportunity in the United States alone

NEW YORK, November 04, 2021 (GLOBE NEWSWIRE) – Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP â„¢) therapies, today announced that the first patient has been enrolled in MicroLine’s second Phase 3 clinical trial, its Proprietary formulation of pilocarpine for the temporary near vision improvement treatment (presbyopia), known as VISION-2.

“Following the completion of the VISION-1 study, we are delighted to launch this second Phase 3 trial which, if successful, will contribute to the clinical evidence supporting a new drug / device combination application to the US FDA.” , said Sean Ianchulev, Chief Executive Officer and Medical Director of Eyenovia. “By leveraging the many benefits of our microdose matrix printing (MAP â„¢) technology, we believe MicroLine has the potential to be one of the first drug treatments to improve blurry near vision that can have a negative impact. negative impact on the quality of life of presbyopic patients.

“Plus, with 18 million people aged 40 to 55 in the United States suffering from presbyopia, this is a significant market opportunity for our business – over billions of dollars according to third-party market research. very recent. We look forward to continuing to advance this promising and differentiated therapeutics through late stage development for the potential benefit of patients, ophthalmologists and shareholders. ”

The VISION-2 study is a double-blind, placebo-controlled, crossover superiority trial in which approximately 140 presbyopic subjects will be treated. During the study, subjects will be randomly assigned to a treatment sequence for a dosage of 2% pilocarpine as well as a placebo, both administered via the Optejet â„¢ dispenser. The primary endpoint is improvement in the near visual acuity corrected high contrast binocular distance measured under low light conditions 2 hours after treatment. Data from the topline is expected in mid-2022.

Summary of VISION-1

In May 2021, Eyenovia announced the positive results of the first MicroLine Phase 3 study, VISION-1. In this trial, the primary endpoint was met with MicroLine 2% statistically superior to placebo, determined by improvement in the high contrast binocular distance corrected for near visual acuity measured under low light conditions 2 hours after treatment. In addition, MicroLine was very well tolerated; the adverse events reported were all mild and transient in nature, with less than 3% of patients reporting headaches / eyebrows. In a post-study survey, 70% of study participants reported strong interest in using MicroLine for near vision improvement if approved. These patients said they would expect to use the product three to four times per week on average.

About the VISION trials

The VISION trials are phase 3, double-blind, placebo-controlled, crossover superiority trials recruiting participants with presbyopia. The primary endpoint is improvement in high contrast binocular distance corrected for near visual acuity under low light conditions. MicroLine is intended for “on-demand” improvement of near vision in people with presbyopia.

About MicroLine for Presbyopia

MicroLine (pilocarpine ophthalmic solution) is Eyenovia’s investigational pharmacological treatment for presbyopia. Presbyopia or hyperopia is the non-preventable, age-related hardening of the lens, which causes the eye’s ability to gradually lose its ability to focus on nearby objects, and is believed to affect nearly 113 million Americans. Treatment options are usually device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near vision by creating an extended depth of field through its small aperture effect. Eyenovia believes that its administration of pilocarpine using the Company’s high-precision microdosing technology could provide a significant improvement in near vision while improving tolerance and usability. MicroLine has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.

About MicroPine for progressive myopia

MicroPine (atropine ophthalmic solution) is the potentially first-in-class investigational topical treatment of Eyenovia for the reduction of the progression of pediatric myopia, also known as myopia, in children aged 3 to 12 years. It was developed for comfort and ease of use in children, and its administration in microdoses is designed to potentially result in low systemic and ocular exposure to the drug. MicroPine has been licensed to Bausch Health Companies, Inc. in the United States and Canada, and to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.

About MydCombi â„¢ for mydriasis

MydCombi is the investigational product of Eyenovia, the first in its class in a fixed dose combination (tropicamide 1% ophthalmic solution and phenylephrine 2.5%) for pharmacological mydriasis (eye dilation), which aims to improve efficacy of the approximately 100 million comprehensive eye examinations performed annually in the United States, as well as the estimated 4 million pharmacologic mydriasis claims for cataract surgery. Developed as a micro-formulation for use without anesthesia, Eyenovia believes that MydCombi will help improve the efficacy, safety and efficiency of pharmacological mydriasis. MydCombi has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.

About Optejet® and Microdose Array Print (MAP ™) Therapeutics

Eyenovia’s Optejet Microdose Formulation and Delivery Platform for Ocular Therapeutics uses high-precision piezoelectric printing technology to deliver 6-8 L of drug, in accordance with the tear film capacity of the eye . We estimate that the volume of ophthalmic solution administered with the Optejet is less than 20% of that delivered using conventional droppers, thereby reducing overdose and exposure to drugs and preservatives. Eyenovia’s patented microfluidic ejection technology is designed for rapid and gentle delivery to the ocular surface, where the solution is delivered to the ocular surface in approximately 80 milliseconds, beating the eye blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings, compared to 40-50% historically seen with conventional droppers. In addition, 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 pipeline of microdose impression (MAP) therapeutics. Eyenovia is currently focused on the advanced development of microdosed drugs for mydriasis, presbyopia and the progression of myopia. For more information visit Eyenovia.com.

The Eyenovia Corporate Information slideshow is available on ir.eyenovia.com/events-and-presentations.

Forward-looking statements

Except for historical information, all statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, without limitation, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statement relating to our future business or other future events or conditions, including market opportunities. estimated 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 and results may, and in some cases are likely to differ materially from what is expressed or expected in forward-looking statements due to many factors discussed from time to time in the documents we file with the Company. US Securities and Exchange. Commission. 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, launch and recruitment (which could still be negatively affected by COVID-19 and the resulting social distancing), timing, progress and results of these trials; the timing and our ability to submit applications for, 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 platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates of the potential market opportunity for our product candidates; the use of third parties to develop and market our product candidates; the ability of ourselves and our partners to develop, implement and maintain timely manufacturing, marketing and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in the 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. Forward-looking statements speak only as of the date on which they are made, and except as may be required by applicable securities laws, Eyenovia does not undertake to update any forward-looking statements.

Contact Eyenovia:
Eyenovia, Inc.
Jean Gandolfo
Financial director

Contact investors Eyenovia:
Eric Ribner
LifeSci Advisors, LLC
(646) 751-4363

Eyenovia press contact:
Sam Choinski
Pazanga Health Communication
(603) 489-5964


Eyenovia Inc. published this content on 05 November 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on 05 November 2021 20:08:52 UTC.



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