Eyenovia Enrolls First Patient in Phase III CHAPERONE Study for Progressive Myopia Program Follows Successful Completion of Phase III Program in Mydriasis New York, NY

Eyenovia Enrolls First Patient in Phase

III CHAPERONE Study for Progressive Myopia

Program Follows Successful Completion

of Phase III Program in Mydriasis

New York, NY - June 4, 2019 -

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics

utilizing its patented piezo-print delivery technology, today announced that it has initiated its MicroPine Phase III program with

the first patient enrolled in its CHAPERONE study.

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 will investigate 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 change in refractive error from baseline through 36 months.

Currently, there are no FDA-approved therapeutics

for the treatment of pediatric progressive myopia - a back-of-the-eye disease characterized by uncontrolled sclero-retinal axial

elongation leading to myopia and potential associated pathologic changes, such as retinal atrophy, macular staphylomas, retinal

detachment and visual impairment. It is estimated that close to 22% of young adults and children in the United States suffer from

myopia, with progressive prevalence in the Caucasian population increasing more than 10-fold between the ages of 5 and 18 years,

while in some regions in Asia, up to 80% of children are reported to be myopic1,2.

"We are very pleased to have initiated

enrollment in our Phase III CHAPERONE study. This program could set

some first-in-class precedents - not only as the first therapeutic indicated for myopic progression, but also the first topical

therapy for a back-of-the-eye disease. Level 1 evidence from recent academic, collaborative, randomized trials such as ATOM1, ATOM2

and LAMP have established that low concentration atropine eye drops can slow progressive myopia by up to 60-70%3-4 with

an acceptable risk-benefit profile, and could be a game-changer in our efforts to fight the global myopia epidemic. We plan to

use the CHAPERONE study, along with the existing evidence from the previous academic collaborative trials, to

submit for the FDA approval of MicroPine," commented Dr. Sean

Ianchulev, Eyenovia's Chief Executive Officer and Chief Medical Officer.

Dr. Pamela Gallin, Clinical Professor of

Ophthalmology in Pediatrics and Director Emeritus, NY Presbyterian - Columbia University Medical Center added, "CHAPERONE

will evaluate the benefit of slowing the progression of myopia with a microdose of low concentration atropine. This may reduce

the problems associated with high myopia, including a range of retinal complications."

believe some of the current challenges faced by clinicians and families exploring myopia control with atropine are adherence

and side effects with long term treatment," commented Dr. Danielle Iacono, Assistant Clinical Professor at SUNY College of

Optometry and one of the Principal Investigators within the CHAPERONE study. "The Eyenovia micro-dosed atropine

formulation to be evaluated in the CHAPERONE study delivers less drug in such a way that it could increase adherence to treatment

and reduce adverse effects. Since these factors are paramount to the success of all ocular medication, I am excited

to begin enrolling patients into this study, which at its conclusion will inform myself and other eye care providers as to the

safety and efficacy of this novel approach to myopia control."

Frequently Asked Questions about Pediatric

Progressive Myopia (PPM)

What is pediatric progressive myopia

PPM is nearsightedness in children that

worsens year after year. This progression may result in severe (or high) myopia, which can be associated with potentially

serious side effects including loss of vision5.

In 2016, there were an estimated 30 million

children with myopia in the United States alone, of which approximately 5 million would be considered highly myopic. Worldwide,

it is estimated that the number of individuals who are myopic could reach up to 4.7 billion, with 900 million of those forecast

to be highly myopic by 20506,7.

How does PPM differ from the myopia

that millions of adults live with?

Myopia that presents later in life tends

not to progress, making it more easily corrected by glasses or contact lenses and often not associated with the potential long-term

consequences of pediatric progressive myopia.

What are some of the potential long-term

consequences of PPM?

Severe myopia after years of PPM in childhood

is a leading cause of functional vision loss, which can in certain cases lead to retinal detachment, glaucoma, cataracts, choroidal

neovascularization, staphyloma and myopic macular degeneration8.

Atropine is a well-established drug that

has a wide range of uses including as a systemic agent to block the effects of nerve agents to treating strabismus or "lazy

eye" when used as a higher concentration eyedrop.

What evidence is there that low concentration

atropine can reduce the progression of PPM?

Administration of low concentration atropine

eyedrops has been demonstrated to be a promising modality to slow PPM in multiple large clinical studies conducted primarily in

Asia, including ATOM13, ATOM24 and LAMP9.

Is atropine used today in patients

There is currently no FDA-approved atropine product for treatment

of PPM. Low concentration atropine eyedrops that are specially compounded by pharmacies are used by some patients to reduce

the progression of the disease; however, these formulations are not shelf-stable over a long period of time, with the potential

to affect potency as well as batch-to-batch variability. Also, because compounded eye medications are not subjected to the rigors

of FDA premarket review, their safety and efficacy have not been well-characterized and in some cases have led to adverse events10.

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical

stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print

delivery technology. Eyenovia's pipeline is currently focused on the late-stage development of microdosed medications for

mydriasis, myopia progression, glaucoma, and other eye diseases. For more Information please visit www.eyenovia.com.

About MicroStat for Mydriasis

MicroStat is Eyenovia's first-in-class

fixed-combination micro-formulation product (phenylephrine 2.5% -tropicamide 1%) candidate for pharmacologic mydriasis (eye dilation)

which is targeted to address the growing needs 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.

We are developing MicroStat to improve the efficacy and tolerability of pharmacologic mydriasis.

Upcoming Milestone: NDA Filing 2020

About MicroPine for Progressive Myopia

MicroPine is Eyenovia's first-in-class

topical treatment for progressive myopia, a back-of-the-eye disease. Progressive myopia is estimated to affect close to 5 million

patients 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.

Early dose finding studies by collaborative academic groups have demonstrated high therapeutic potential with low dose atropine

which can reduce myopia progression by 60 - 70% with a sustained effect through three years. 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 Group Trials)

About MicroProst for Glaucoma and Ocular

MicroProst is Eyenovia's proprietary latanoprost

formulation product candidate, which is being developed as a first-line treatment for the reduction of IOP in patients with Chronic

Angle Closure Glaucoma (CACG), as well as Primary Open Angle Glaucoma (POAG) and Ocular Hypertension. Currently, there are no FDA-approved

therapies specifically indicated for CACG, which accounts for an estimated 10% and 50% of all glaucoma diagnoses in the United