Shire resubmits lifitegrast (SHP 605) to the FDA for dry eye disease.

Shire plc has announced it has resubmitted the New Drug Application (NDA) to the FDA for its investigational candidate, lifitegrast (SHP 605), for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA on October 16, 2015.

Addressing the FDA request for an additional study, Shire included in its NDA resubmission package data from OPUS-3, a Phase III efficacy and safety trial with a primary endpoint of patient-reported symptom improvement. The resubmission package also included information requested by the FDA regarding product quality. The new drug application for lifitegrast now includes data from one Phase II study, three Phase III efficacy and safety studies (OPUS-1, OPUS-2 and OPUS-3), and one long-term (one-year) Phase III safety study (SONATA). The FDA has 30 days after resubmission of an NDA to acknowledge receipt and determine if the submission is a complete response. Upon acceptance, the FDA will provide Shire with a PDUFA date anticipated to be within six months of the date of submission.

Comment: Lifitegrast is a potential competitor for Restasis from Allergan, which dominates the dry eye market in the US with sales over $1 billion and extended patent life to 2024. Restasis marketing for dry eye disease is off label.