02.06.19

Eyenovia Announces FDA Acceptance of IND Application for MicroPine

Source: Eyenovia

Eyenovia announced that the FDA has accepted the company’s investigational new drug (IND) application to initiate the CHAPERONE study – a phase 3 registration trial of MicroPine to reduce the progression of myopia in children.

“We are very pleased to have received FDA acceptance of our IND application for the phase 3 registration trial for our MicroPine program. This acceptance allows us to initiate phase 3 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 evidence4 that topical lower doses of atropine treatment have demonstrated robust and sustained effect in slowing progressive myopia by up to 60-70%,” Sean Ianchulev, MD, MPH, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “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 is a U.S.-based, multicenter, randomized, double-masked trial that will enroll more than 400 children between 5-12 years of age. Participants will be equally randomized to receive treatment with either of two MicroPine treatment concentrations or a placebo control arm.

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

 

References

  1. Pan CW, Ramamurthy D, Saw SM. Worldwide prevalence and risk factors for myopia. Ophthalmic Physiol Opt. 2012;32:3e16.
  2. Chua WH, Balakrishnan V, Chan YH, Tong L, Ling Y, Quah BL, Tan D. Atropine for the treatment of childhood myopia. Ophthalmology. 2006;113(12):2285–2291.
  3. Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (atropine for the treatment of myopia 2). Ophthalmology. 2012;119:347–354.
  4. Stacy L. Pineles, MD,1 Raymond T. Kraker, MSPH,2 Deborah K. VanderVeen, MD,3 Amy K. Hutchinson, MD,4 Jennifer A. Galvin, MD,5 Lorri B. Wilson, MD,6 Scott R. Lambert, MD. Atropine for the Prevention of Myopia Progression in Children. A Report by the American Academy of Ophthalmology. Ophthalmology 2017;124:1857-1866.

 

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