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Wednesday / August 21.
HomeminewsMyopia Topical treatment Enters Phase III Trial

Myopia Topical treatment Enters Phase III Trial

MicroPine, a high-precision micro-dosing delivery system to better manage and treat paediatric patients with myopia is to enter a Phase III registration trial in the United States.

Currently, there are no FDA-approved therapies to slow the progression of myopia, a condition that, if uncontrolled, can lead to retinal atrophy, macular staphylomas, retinal detachment and visual impairment. It is estimated that approximately 9 per cent of children in the United States have myopia and up to 80 per cent of children start 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 per cent.2-3

MicroPine has been developed by Eyenovia, a US clinical stage ophthalmic biopharmaceutical company which is developing a pipeline of microdose therapeutics using its patented piezo-print delivery technology.

by combining the knowledge gained from these studies with our OpteJet… we have the opportunity to potentially change the odds of progressive myopia

In a statement Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer said, “We are very pleased to have received FDA acceptance of our Investigational New Drug application for the Phase III registration trial for our MicroPine program. This acceptance allows us to initiate Phase III trial enrolment 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 evidence4 that topical lower doses of atropine treatment have demonstrated robust and sustained effect in slowing progressive myopia by up to 60-70 per cent. 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.”

The CHAPERONE study, a U.S. based, multi-center, randomised, double-masked trial, will enrol more than 400 children between five to 12 years of age. Participants will be equally randomised to receive treatment with either of two MicroPine treatment concentrations or a placebo control arm.