Sydnexis sets FDA advisory committee date for SYD-101 NDA review
核心洞察
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 (搜索).
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.
Sydnexis, Inc. said the FDA has scheduled an Advisory Committee meeting, including an Open Public Hearing, for October 30, 2026 to review the New Drug Application for SYD-101, a low-dose atropine formulation for pediatric progressive myopia (搜索) (PPM). The company said it will release meeting logistics, including how the public may register or submit comments, as they become available.
The filing rests on the Phase 3 STAR trial, a global, randomized, vehicle-controlled study of SYD-101 in 847 children aged 3 to 14 in the US and Europe. The prespecified primary endpoint assessed whether treatment reduced the proportion of children with confirmed progression beyond -0.75 D at Month 36, a threshold agreed with the FDA for use in STAR; annual myopia (搜索) progression rate was the key secondary endpoint. SYD-101 0.01% met both endpoints (p=0.0226 and p=0.0002) and was well tolerated, with no new safety signals through Month 48.
SYD-101 is already approved in the European Union and the UK, where it is licensed to Santen S.A. (搜索) and marketed as Ryjunea. PPM is described as the most common eye disease in children, with nearly one-third of children worldwide affected and prevalence projected to exceed 740 million cases by 2050; there are currently no FDA-approved pharmaceutical options in the US to slow progression.
Source: Morningstar