74 MMP | The FDA Is Giving Low-Dose Atropine a Second Chance

The FDA just gave myopia management a second chance.

Last October, Sydnexis’ SYD-101 — the low-dose atropine drop that would be the first FDA-approved pharmaceutical treatment for pediatric progressive myopia — was rejected in a Complete Response Letter that left most of us scratching our heads. The Phase 3 STAR trial was the largest pediatric myopia program ever completed (847 children, ages 3–14), the data looked sound, and the FDA’s reasoning never really came.

Now, after Sydnexis filed a formal dispute, the FDA has announced it will convene an advisory committee to review the application. It’s a redo — and this time, the people in the room will actually know myopia.

To unpack what that means, I brought back my regular guest contributor (and dad), Dr. Cary Herzberg — pioneer of myopia management with 40+ years in practice.

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