FDA Issues Complete Response Letter for Dry Eye Tx
Shire announced that the Food and Drug Administration (FDA) has issued a complete response letter (CRL) requesting an additional clinical study for the New Drug Application (NDA) of lifitegrast for the signs and symptoms of dry eye disease in adults.
Shire has recently completed a Phase 3 study of lifitegrast, OPUS-3, that is expected to be the basis of Shire's response to the CRL. The company will also address the FDA's request for more information related to product quality.
OPUS-3, a randomized, double-blind, 12-week Phase 3 study enrolled 711 patients to evaluate the efficacy and safety of lifitegrast. The primary endpoint is patient-reported symptom improvement as measured by the Eye Dryness Score (EDS) scale. Results of OPUS-3 are expected before year-end.
The lifitegrast NDA included data from four randomized, controlled clinical trials with more than 1,800 patients, including one Phase 2 study and three Phase 3 studies, OPUS-1, OPUS-2, and SONATA.
For more information call (800) 536–7878 or visit Shire.com.