63 MMP | Why the FDA Said No to a Drug That Could Save Kids' Eyes

A Texas ophthalmologist sits down to explain the lifetime risks of myopia to a 6-year-old's mom — and mid-sentence realizes the mom, still in her 20s, has already had retinal detachments in both eyes from her own untreated nearsightedness.That's the gap this episode is about: the gap between what we know myopia does to people, and what the FDA's drug division decided was "not clinically meaningful" when it rejected SYD-101 — Sydnexis's stable, low-dose atropine drop — last fall.Dr. Cary Herzberg, a 40-plus-year ortho-K/myopia management pioneer, walks through the STAR study, the fast-progressor data Sydnexis dropped at AAPOS, and why a drug that's approved in Europe is still locked out of American practices.We get into how the FDA's own request to add older patients dragged the headline numbers down, what 47.9% / 37.6% / 28.0% actually means for a kid, and what an everyday optometrist, ophthalmologist, or parent can do this week to push back.What We Cover In This Episode:Sydnexis & SYD-101 — the company and the 0.01% low-dose atropine drop that this episode is about. https://sydnexis.com/Sydnexis Press Release Data Presented At AAPOS — https://www.businesswire.com/news/home/20260323823740/en/Sydnexis-Announces-New-Data-from-Phase-3-STAR-Trial-of-SYD-101-Presented-at-2026-AAPOS-Annual-MeetingThe STAR study — Sydnexis’s 3-year, 847-patient pediatric myopia trial across the U.S. and Europe. https://sydnexis.com/resource/evidence-from-the-star-study-a-novel-low-dose-atropine-eye-drop-slows-the-progression-of-pediatric-myopia/https://iovs.arvojournals.org/article.aspx?articleid=2804883Washington Post article — A drug for myopia could help millions of kids. The FDA is keeping it off the shelves (by David G. Hunter) https://www.washingtonpost.com/opinions/2026/02/10/fda-myopia-drug-trial/Inside Health Policy article — Pediatric Myopia Drug is Latest In String of Unexpected FDA Rejections (by Jessica Karins) https://insidehealthpolicy.com/inside-drug-pricing-daily-news/pediatric-myopia-drug-latest-string-unexpected-fda-rejectionsAmerican Association for Pediatric Ophthalmology and Strabismus (AAPOS)— https://www.aapos.org/homeThe LAMP study — https://pubmed.ncbi.nlm.nih.gov/30514630/Stellest spectacle lenses — https://www.essilorluxottica.com/en/newsroom/press-releases/essilor-stellest-fda/American Academy of Orthokeratology and Myopia Control (AAOMC) —https://aaomc.org/Petition to classify pediatric progressive myopia as a disease — Urgent Call for U.S. Children to Have Access to an FDA-Approved Low-Dose Atropinehttps://www.change.org/p/urgent-call-for-u-s-children-to-have-access-to-an-fda-approved-low-dose-atropine-68d0a62c-8058-48bb-ab09-9c586d3a3ff6?recruiter=1397201700&recruited_by_id=25f73080-d542-11f0-94d3-2b1ed6b14439&utm_source=share_petition&utm_campaign=petition_dashboard&utm_medium=copylinkWHO projection — https://www.sciencedaily.com/releases/2016/02/160217113308.htm