The MicroPine program for the treatment of progressive myopia will begin a phase 3 pivotal study in 2019, according to a press release from Eyenovia.
Eyenovia has received feedback that it will need to conduct only one phase 3 pivotal trial for registration instead of two, based on discussions with the FDA and evidence from academic and collaborative trials.
MicroPine is a micro-therapeutic formulation of atropine designed to slow the progression of myopia. There are no FDA-approved therapies currently available to treat the progression of refractive myopia.
In addition, the company has appointed 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, the release said.
“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,” Frederick said in the 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 comorbidities.”