FDA taking another look at eye therapy rejected under Makary

For eight months, Sydnexis has argued that FDA's rejection of SYD-101, its low-dose atropine drop for pediatric myopia, contradicted widely accepted medical practice. The company has garnered support from ophthalmologists, the editorial page of The Wall Street Journal, and politicians. Now it will make that case to an advisory committee.

The advisory committee will not be asked to determine if Sydenxis Inc. hit the primary endpoint in its Phase III trial. In a trial the company says is the largest ever conducted in pediatric myopia, SYD-101 achieved the primary endpoint, reducing  the proportion of patients with confirmed progression of -0.75 D compared to placebo (p=0.0226), and a secondary endpoint, annual progression rate. ...