Clinical Trials
4
3 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2014
Active, not recruiting
3
75.0%
Completed
1
25.0%
No approval data available
- The FDA has scheduled an Advisory Committee meeting with an Open Public Hearing for October 30, 2026 to review the NDA for SYD-101 in pediatric progressive myopia. - SYD-101, a low-dose atropine formulation, met its Phase 3 STAR primary endpoint with p=0.0226 and key secondary endpoint with p=0.0002 in 847 children. - SYD-101 is already approved in the EU and UK as Ryjunea, licensed to Santen, while no FDA-approved pharmaceutical option exists in the US.
- The FDA plans to hold an advisory committee meeting to review SYD-101, a low-dose atropine 0.01% formulation for pediatric progressive myopia, following a prior complete response letter rejecting its NDA. - SYD-101 met its phase 3 STAR study primary and secondary endpoints, including significant reduction in myopia progression at 36 months (p = 0.0226), yet the FDA questioned the durability and robustness of the treatment effect. - Sydnexis has requested that practicing pediatric ophthalmologists and optometrists be included on the advisory committee to ensure real-world clinical perspectives are represented. - SYD-101 is already approved in the European Union and United Kingdom under the brand name Ryjunea, while no FDA-approved pharmaceutical currently exists for pediatric progressive myopia in the U.S.
