Eyenovia announced that following discussions with the FDA, it has received feedback on its pivotal trial protocol design, as well as confirmation to advance its MicroPine therapeutic program for the treatment of progressive myopia into phase 3 clinical development. Based on the growing clinical evidence from academic and collaborative trials, Eyenovia has received feedback that only one phase 3 pivotal study will be required for registration instead of two trials. The MicroPine phase 3 trial for myopia is planned to start in the first half of 2019.
MicroPine is Eyenovia’s proprietary micro-therapeutic formulation of atropine to slow the progression of myopia.
To advise the company on the myopia program, Eyenovia has appointed accomplished pediatric ophthalmologist Douglas Fredrick, MD, Clinical Professor of Ophthalmology and Pediatrics at Lucile Packard Children’s Hospital at Stanford, to its Scientific Advisory Board and Myopia Program Steering Committee.
“Eyenovia recently published the results of its second phase 2 trial validating the strong biologic and pharmacodynamic effect of its piezo-print microformulation approach, designed to improve the therapeutic index of many front-of-the-eye treatments,” Dr. Fredrick said in a company news release. “This is a particularly exciting time to join Eyenovia as we further evaluate the company’s high-precision micro-dosing delivery system to better manage and treat pediatric patients suffering from myopia, for which there remains a significant unmet need due to associated co-morbidities. I look forward to working with the team and guiding the company based on the positive feedback from the FDA to advance the MicroPine program to initiation of the phase 3 trial.”
Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer added, “With deep ophthalmology experience, particularly in myopia prevention and pediatric cataracts, Dr. Fredrick brings invaluable expertise to Eyenovia. Along with Dr. Pamela Gallin, Professor of Pediatric Ophthalmology, Columbia University, the pediatric steering committee of our Scientific Advisory Board has some of the top physicians in the field, which will enable us to better navigate the development opportunities ahead. We look forward to working with these experts to further develop our micro-dose delivery technology, which has great potential to transform the therapeutic paradigm for front-of-the-eye diseases.”