Full Press Release Details
Eyenovia Resumes Recruitment of Phase
III CHAPERONE Study for Progressive Myopia
New York, NY - June 30, 2020
- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose
array print (MAP ) therapeutics, today announced that the Company
has resumed patient enrollment for its Phase III CHAPERONE study for the treatment of progressive myopia, following a temporary
pause due to the COVID-19 pandemic.
"We are excited to resume enrollment
in our Phase III CHAPERONE study among nearly all of our clinical sites for the treatment of progressive myopia in children. Despite
conditions caused by COVID-19, we continued to follow-up with and monitor previously enrolled CHAPERONE patients via telemedicine
and remote monitoring processes. We are pleased to report that all patients previously randomized to treatment have continued to
progress in the study. We are working in close partnership with our investigational sites as we advance to complete trial enrollment,
which will depend on the continued improvement of the COVID-19 pandemic," commented Dr. Sean Ianchulev, Eyenovia's
Chief Executive Officer and Chief Medical Officer.
The CHAPERONE study is a U.S.-based, multi-center,
randomized, double-masked trial that will enroll more than 400 children between 3-12 years of age. The study is investigating the
safety and efficacy of MicroPine for the reduction of progressive myopia using Eyenovia's proprietary atropine topical micro-formulation
delivered by the Optejet dispenser. Subjects will be randomized to receive treatment with either of two MicroPine concentrations
or a placebo. The primary endpoint of the study is the proportion of eyes with < 0.5 D increase in refractive error from baseline
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical
stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAPTM) therapeutics. Eyenovia's
pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis.
For more Information please visit www.eyenovia.com.
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic solution)
is Eyenovia's first-in-class topical treatment for progressive myopia, a back-of-the-eye condition commonly known as nearsightedness.
Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial
elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy,
macular staphylomas, retinal detachment and visual impairment. MicroPine has been developed for comfort and ease-of-use in children.
Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic
evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the
role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology
2016; 123(2) 391:399).
Feasibility Dose-finding Atropine Studies:
ATOM 1; ATOM 2; LAMP (Independent Collaborative
About MicroLine for Presbyopia
MicroLine is Eyenovia's pharmacologic
treatment for presbyopia. Presbyopia is the non-preventable, age related hardening of the lens, which causes a gradual loss of
the eye's ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Current treatment options
are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the
pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes
that its administration of pilocarpine using the company's high precision microdosing technology may provide a meaningful
improvement in near vision while enhancing tolerability and usability.
About MicroStat for Mydriasis
is Eyenovia's first-in-class fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic
mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive and
diabetic eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications
for cataract surgery. Developed for use without anesthetic, we are developing MicroStat to improve the efficacy and tolerability
of pharmacologic mydriasis.
About Optejet and MicroRx Ocular
Eyenovia's Optejet microdose formulation
and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver approximately 8 L of drug,
consistent with the capacity of the tear film of the eye. We believe the volume of ophthalmic solution administered with the Optejet
is less than 75% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives.
Eyenovia's patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is
dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular 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%
with conventional eyedroppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance
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
in the United States for our product candidates. 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 SEC. In addition, such statements could be affected by risks and
uncertainties related to, among other things: impacts of and uncertainty related to COVID-19; 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 and our ability to submit applications for, obtain
and maintain regulatory approvals for our product candidates; fluctuations in our financial results, particularly given market
conditions and the potential economic impact of COVID-19; our need to raise additional money to fund our operations for at least
the next 12 months as a going concern; the potential impacts of COVID-19 on our supply chain; the potential success of our reprioritized
pipeline; any cost savings related to our reprioritized pipeline; our estimates regarding the potential market opportunity for
our product candidates; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical
utility of our product candidates; our ability to timely develop and implement anticipated manufacturing, commercialization and
marketing capabilities and strategies for existing product candidates; our ability to attract and retain key personnel; 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, we
do not undertake any obligation to update any forward-looking statements.
Chief Financial Officer
Tram Bui / Alexander Lobo
Phone: 646-536-7035/7037