Full Press Release Details
Eyenovia confirms expanded MicroProst
Phase III indication to enroll broad patient population for IOP lowering
Expanded, more efficient
development aimed at maximizing MicroProst's program value
New York, NY - February 13, 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 confirmed a broad patient population for its Phase III
MicroProst program (microdose latanoprost with Optejet delivery) for the lowering of intraocular pressure (IOP). Following
discussions with the U.S. Food and Drug Administration (FDA), the study population will include chronic angle closure glaucoma
(CACG), as well as open angle glaucoma (OAG) and ocular hypertension (OHT) patients, representing a total addressable population
of approximately 4 million in the United States. As anticipated, the Phase III program will be optimized to consist of a single
MicroProst Phase III trial and supplemented with existing data on latanoprost for IOP lowering.
"We believe that our MicroProst study
will include one of the broadest patient populations in glaucoma drug development to date. If approved, MicroProst could have one
of the widest indications of commercially available IOP-lowering therapies, as well as represent the first FDA-approved drug specifically
indicated for chronic angle closure glaucoma," commented Dr. Sean Ianchulev, Eyenovia's Chief Executive Officer and
Chief Medical Officer. "Based on the results of our earlier Phase II trial for IOP lowering, we believe that MicroProst may
achieve similar clinical efficacy with improved tolerability versus latanoprost administered in drop form, which can overdose the
eye with potentially harmful preservatives and active ingredient."
"Together, open angle
glaucoma and ocular hypertension represent a larger patient population in the United States compared to chronic angle
closure glaucoma. Having an FDA-approved drug with all three conditions specified in the label means that patients who are
currently prescribed or are candidates for prostaglandin therapy may have the option for next-generation, smart,
micro-dose delivery," said Shan Lin, M.D., Glaucoma Specialist at the Glaucoma Center of San Francisco. "MicroProst may open up possibilities for patients who cannot use current eyedropper treatments due to
intolerance to high-volume drug and preservative, inability to correctly instill eye drops, or poor compliance."
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.eyenoviabio.com.
About MicroProst for Glaucoma
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 Ocular Hypertension (OHT) and Primary Open Angle Glaucoma (POAG).
| Updated Plan | |
| Study Population | CACG, OHT and POAG |
| Phase III Program Enrollment | Single Phase III trial |
| Sample Size | N250 |
| Primary Phase III Endpoint | IOP lowering from baseline through 3 months |
| Total Addressable U.S. Population | Approximately 4 million |
Feasibility Dose-Finding Studies: MicroProst
Upcoming Milestone: MicroProst Phase III
Trial First Patient In H1 2019
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 (Independent Collaborative Group Trials)
Upcoming Milestone: MicroPine Phase III
Trial First Patient In H1 2019
About MicroStat for Mydriasis
MicroStat is Eyenovia's first-in-class
fixed-combination micro-formulation product (phenylephrine-tropicamide) 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 help improve efficacy, usability and tolerability of pharmacologic mydriasis.
Feasibility Dose-finding Studies: MicroStat
Ph I/II; MicroStat Ph II
Registration Studies: MicroStat MIST-1
Upcoming Milestone: MicroStat MIST-2 Phase
III Results H1 2019; NDA Filing Q1 2020
About MicroTears OTC for Dry Eye
MicroTears is a micro-droplet ocular surface
tear replenishment product candidate for the estimated $2 billion+ (200 million units) global annual OTC artificial tear market.
Upcoming Milestone: OTC Registration H1
About OpteJet and MicroRx Ocular Therapeutics
Eyenovia's OpteJet microdose formulation
and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6 - 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 gentle ocular surface delivery in less than 80 milliseconds,
beating the ocular blink reflex. The OpteJet's targeted delivery system has demonstrated 85% topical delivery efficacy compared
to 40-50% with the conventional eyedropper, and its smart electronics and mobile e-health technology are designed to track and
enhance patient compliance.
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. 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: risks involved in clinical trials, including, but
not limited to, the initiation, timing, progress and results of such trials; the timing and our ability to submit applications
for, and obtain and maintain regulatory approvals for, our product candidates, and to raise money, including in light of U.S. government
shut-downs; our ability to develop and implement commercialization, marketing and manufacturing capabilities and strategies; the
potential advantages of our product candidates; 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; the impact of
government laws and regulations; 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