Eyenovia to Present Clinical Study Updates at the American Academy of Optometry Annual Meeting
05 Ottobre 2020 - 1:00PM
Business Wire
Optometry and ophthalmology doctors to present
latest analyses and updates from studies of its MAP therapeutics
for mydriasis, pediatric myopia and presbyopia
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose array
print (MAP™) therapeutics, today announced that Drs. Siddarth Rathi
and April Jasper will present the latest analyses and updates from
the company’s clinical studies at the American Academy of Optometry
Academy 2020 At Home Con.
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On Wednesday, October 7, April Jasper, OD, medical monitor for
the company’s CHAPERONE study and member of the Eyenovia Scientific
Advisory Board, will provide pre-recorded updates on the CHAPERONE
(evaluation of low-dose atropine for the reduction of pediatric
myopia progression) and the VISION (evaluation of low-dose
pilocarpine for improvement in near vision) clinical trials. Dr.
Jasper will also provide an update on the company’s upcoming
Mydcombi (low-dose tropicamide and phenylephrine fixed combination
for pupil dilation) NDA filing with the U.S. Food and Drug
Administration (FDA).
On Thursday, October 8 at 6 p.m. EDT, Siddarth Rathi, MD, of The
Eye Institute of West Florida and medical monitor for the MIST 1
and MIST 2 studies, will present additional analyses of data from
the MIST 1 and MIST 2 studies of Eyenovia’s proprietary
first-in-class fixed combination microdose formulation of
phenylephrine and tropicamide for mydriasis (pupil dilation).
Clinical results will cover Pupil Dilation Speed with MAP™ Fixed
Combination (FC) Tropicamide 1% Phenylephrine 2.5%
(TR-PH)-Ophthalmic Solution.
About Eyenovia
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose array
print (MAP™) 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 being evaluated in
the CHAPERONE Phase 3 clinical study for reduction in pediatric
myopia progression. 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, myopic maculopathy, retinal detachment, posterior
subcapsular cataract, glaucoma and visual impairment. MicroPine has
been developed for comfort, hygiene 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 Group Trials)
About MicroLine for Presbyopia
MicroLine (pilocarpine ophthalmic solution) is a pharmacologic
treatment for presbyopia which will be evaluated in the VISION 1
and VISION 2 Phase 3 clinical studies. Presbyopia is the
non-preventable, age-related hardening of the natural lens, which
causes a gradual loss of the eye’s ability to accommodate or focus
on nearby objects and is estimated to affect nearly 113 million
Americans. Current treatment options are typically device-based,
such as reading glasses, progressive and multifocal 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 could provide a meaningful improvement in
near vision while enhancing tolerability and usability.
About Mydcombi™ for Mydriasis
Mydcombi 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 Mydcombi to
improve the efficacy and tolerability of pharmacologic
mydriasis.
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 μL 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. The
design of Optejet includes no protruding nozzle to help reduce the
risks of dispenser to eye contact and contamination reported with
conventional droppers. Additionally, its smart electronics and
mobile e-health technology are designed to track and enhance
patient compliance.
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version on businesswire.com: https://www.businesswire.com/news/home/20201005005232/en/
Eyenovia Contact: John Gandolfo Eyenovia, Inc. Chief
Financial Officer jgandolfo@eyenovia.com
Media Contact: Diana Soltesz Pazanga Health
Communications dsoltesz@pazangahealth.com 818-618-5634
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