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Eyenovia Announces FDA Acceptance of IND Application for MicroPine to Reduce the Progression of Myopia
Feb. 06, 2019 08:45AM PST
Biotech InvestingEyenovia (NASDAQ:EYEN) has announced that the US Food and Drug Administration has accepted its Investigational New Drug (IND) application to initiate the company’s CHAPERONE Phase III study to reduce the progression of myopia in children. As quoted in the press release: Currently, there are no FDA-approved therapies to slow the progression of myopia, a condition …
Eyenovia (NASDAQ:EYEN) has announced that the US Food and Drug Administration has accepted its Investigational New Drug (IND) application to initiate the company’s CHAPERONE Phase III study to reduce the progression of myopia in children.
As quoted in the press release:
Currently, there are no FDA-approved therapies to slow the progression of myopia, a condition that, if uncontrolled, can in some cases 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 United States have myopia resulting in a potential U.S. market for MicroPine of approximately $5 billion. Outside of the United States, we estimate the market potential for MicroPine is even larger – with up to approximately 80% of children starting out myopic in Asian markets. There is a growing body of evidence that supports the therapeutic effect of low dose atropine, potentially slowing myopia progression by 60-70%2-3.
“We are very pleased to have received FDA acceptance of our IND application for the Phase III registration trial for our MicroPine program. This acceptance allows us to initiate Phase III trial enrollment in the first half of 2019. Our work in this area follows in the footsteps of the ATOM 1, ATOM 2, and LAMP clinical studies performed by academic-collaborative groups. The American Academy of Ophthalmology recently cited Level 1 evidence4that topical lower doses of atropine treatment have demonstrated robust and sustained effect in slowing progressive myopia by up to 60-70%,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. “We believe that by combining the knowledge gained from these studies with our OpteJet™, high-precision piezo-print microdose technology, we have the opportunity to potentially change the odds of progressive myopia.”