ARTICLE | Clinical News

Luveniq voclosporin regulatory update

August 9, 2010 7:00 AM UTC

Lux received a complete response letter from FDA for an NDA for Luveniq voclosporin to treat non-infectious uveitis in the intermediate or posterior segments of the eye. According to Lux, FDA said in the letter that it considers data from only 1 of the 2 pivotal trials included in the application as supportive for approval. The company plans to begin an additional pivotal trial of Luveniq this year. ...