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A Change.org petition with more than 800 signatures is calling on the FDA to approve low-dose atropine to slow the progression of pediatric myopia.
It comes after the FDA decided not to approve SYD-101 (0.01% atropine, Sydnexis) in October despite acknowledging the drug met its primary efficacy endpoint in a phase 3 study and had no safety or quality issues.
The petition was posted on Dec. 9 by the Pediatric Progressive Myopia Coalition, a partnership between Robert S. Gold, MD, FAAP, a pediatric ophthalmologist at Eye Physicians of Central Florida, and Cheryl Chapman, OD, FIAOMC, FAAO, Dipl