The Myopia Mindset
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/ [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-Meeting [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-Meeting] The 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://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=2804883 [https://iovs.arvojournals.org/article.aspx?articleid=2804883] Washington 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/ [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-rejections [https://insidehealthpolicy.com/inside-drug-pricing-daily-news/pediatric-myopia-drug-latest-string-unexpected-fda-rejections] American Association for Pediatric Ophthalmology and Strabismus (AAPOS)— https://www.aapos.org/home [https://www.aapos.org/home] The LAMP study — https://pubmed.ncbi.nlm.nih.gov/30514630/ [https://pubmed.ncbi.nlm.nih.gov/30514630/] Stellest spectacle lenses — https://www.essilorluxottica.com/en/newsroom/press-releases/essilor-stellest-fda/ [https://www.essilorluxottica.com/en/newsroom/press-releases/essilor-stellest-fda/] American Academy of Orthokeratology and Myopia Control (AAOMC) — https://aaomc.org/ [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 Atropine https://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=copylink [https://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=copylink] WHO projection — https://www.sciencedaily.com/releases/2016/02/160217113308.htm [https://www.sciencedaily.com/releases/2016/02/160217113308.htm]
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