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# Sydnexis Pediatric Myopia Drug Meets Endpoints
- URL: https://www.fdaweb.com/sydnexis-pediatric-myopia-drug-meets-endpoints/
- Published: 2025-11-04T12:00:00.000Z
- Updated: 2026-09-14T15:25:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160157

Sydnexis says its SYD-101, a proprietary 0.01% atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability to slow the progression of myopia in children, met both the primary and key secondary endpoints in the Phase 3 STAR trial. A company [statement](https://sydnexis.com/sydnexis-announces-topline-pivotal-data-from-phase-3-star-trial-of-syd-101-for-patients-with-pediatric-progressive-myopia-presented-at-amcp-nexus-2025/?ref=fdaweb.com) says treatment effects were evident by month 12 and sustained through month 36, with the greatest treatment benefit observed in younger children, in trial participants with a history of myopia progression, or when administered earlier in progression.

Sydnexis says STAR evaluated 847 children aged 3-14 at treatment initiation. The primary efficacy endpoint was the proportion of patients with confirmed progression of -0.75 diopters, an endpoint proposed by FDA, and a key secondary endpoint was the annual progression rate. It says SYD-101 met both the primary and key secondary endpoints and was well tolerated, with no unexpected atropine-related adverse events.