FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

The FDA recently issued a complete response letter (CRL) to Sydnexis, rejecting its New Drug Application (NDA) for SYD-101, a proprietary low-dose atropine (0.01%) eye drop designed to slow the progression of pediatric myopia135.

The agency found insufficient evidence to support the drug’s efficacy in children, despite meeting primary endpoints in the pivotal STAR phase 3 clinical trial13. The FDA did not cite any safety or quality concerns3.

If approved, SYD-101 would have been the first FDA-approved pharmacologic treatment for pediatric myopia in the U.S., addressing an unmet medical need for about 28 million affected children126.

Sydnexis remains committed to working with the FDA to address the concerns and pursue approval, while SYD-101 (marketed as Ryjunea) has already been authorized by the European Commission for use in the EU5.

There is no news item in the search results about Chugai acquiring Renalys for $98M upfront; the provided sources only cover the FDA's decision on SYD-101.

Sources:

1. https://www.pharmacytimes.com/view/fda-cites-insufficient-data-for-syd-101-potential-therapy-to-slow-pediatric-myopia-progression

2. https://ophthalmologybreakingnews.com/sydnexis-announces-fda-acceptance-of-nda-for-syd-101

3. https://www.ophthalmologytimes.com/view/fda-issues-complete-response-letter-to-sydnexis-for-syd-101-in-pediatric-myopia

5. https://eyewire.news/news/fda-does-not-approve-sydnexis-syd-101-in-pediatric-myopia

6. https://www.contemporarypediatrics.com/view/fda-accepts-nda-for-syd-101-to-treat-pediatric-myopia