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
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