Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company, developing a pipeline of therapeutics for front and back-of-the-eye diseases using a novel microdosing approach. We have built a robust pipeline focused on the late-stage development of microdosed therapeutics for pharmacologic mydriasis (pupil dilation), progressive myopia and elevated intraocular pressure related to CACG, OAG and OHT. Our portfolio benefits from our therapeutic approach, which has been validated by collaborative academic studies such as ATOM1, ATOM2 and LAMP as well as Eyenovia’s own phase II and III studies demonstrating the benefits of microdosing therapeutics to the eye.
Recently, we completed our phase III trials for our first program, MicroStat, a fixed-combination micro-formulation product (phenylephrine-tropicamide) candidate for pharmacologic mydriasis. MicroStat is targeted to help improve efficacy, usability and tolerability of the estimated 80 million office-based comprehensive and diabetic eye exams and 4 million ophthalmic surgical dilations performed annually in the U.S. With our phase III positive results in hand, we are now preparing the registration and stability manufacturing lots and expect to file our New Drug Application (NDA) for MicroStat with the FDA in 2020.
MicroPine is our topical treatment for progressive myopia in children using atropine. Progressive myopia is a back-of-the-eye disease that currently has no FDA-approved therapies to our knowledge and is a condition that, if uncontrolled, can be associated with major pathologic changes such as retinal atrophy, macular staphylomas, retinal detachment and visual impairment. It is estimated that approximately 9% of children in the U.S. have myopia, making it an estimated $5 billion addressable market. In recent years, there have been multiple collaborative academic studies, which have demonstrated compelling efficacy of low dose atropine for the slowing of myopia progression by up to 70%. Based on these studies, we believe that our microdose formulation of atropine holds the potential to be the first FDA approved treatment to slow myopia progression. Earlier this year, we received FDA acceptance of our Investigative NDA and expect to initiate the phase III CHAPERONE trial towards the middle of this year. We believe our horizontal delivery, patient compliance monitoring and microdosing for less ocular and systemic exposure could differentiate us in the market.
Finally, MicroProst is our proprietary latanoprost 0.0075% formulation product candidate, which is being developed as a treatment for the reduction of intraocular pressure (IOP) in patients with Chronic Angle Closure Glaucoma (CACG), as well as Ocular Hypertension and Primary Open Angle Glaucoma (POAG) representing a total addressable population in the United States of approximately 4 million. Currently, there are no FDA-approved therapies to our knowledge specifically indicated for CACG. We recently completed a phase II study (EYN PG21) for MicroProst demonstrating IOP lowering of up to 30%. Looking ahead, we anticipate initiating our phase III registration trial towards the end of 2019.
Behind all of our clinical programs is our enabling technology, the Optejet™, which uses high-precision piezo-print “ink jet” technology to deliver 6-8 μL of drug, consistent with the capacity of the tear film of the eye. Our microdosing technology gently and precisely delivers medication to the cornea, while simultaneously beating the eye’s blink reflex. This enables us to deliver the desired clinical effect with less ocular and systemic exposure which often results in side effects that plague many ophthalmic medications. In addition, the Optejet's smart electronics and mobile e-health technology are designed to track and enhance patient accuracy and compliance.
As we work to advance our late stage pipeline, Eyenovia remains committed to Orange County, the center for ophthalmology technology development and commercialization. Rich in talent and experience in multiple markets, our commercial and clinical organizations are based in Orange county to take advantage of these benefits, as well as maintain close ties with the academic centers of excellence and key clinician educators and leaders in the area.