> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Santen NDA Filed for Uveitis Drug
- URL: https://www.fdaweb.com/santen-nda-filed-for-uveitis-drug/
- Published: 2017-04-25T12:00:00.000Z
- Updated: 2026-09-14T22:19:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138537

FDA has accepted for review a Santen Pharmaceutical NDA for intravitreal (IVT) sirolimus for treating non-infectious uveitis of the posterior segment (NIU-PS). Uveitis is a leading cause of preventable blindness in working-age adults. The agency has set a user fee review target date of 12/24.

  
IVT sirolimus, an mTOR inhibitor, is an investigational first-in-class targeted, immunoregulator. The submission is supported by data from the SAKURA Program, the largest Phase 3 global clinical program to date evaluating patients with NIU-PS, according to Santen.