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Shire resubmits NDA for lifitegrast in response to FDA request for data
Shire has resubmitted its new drug application to the FDA for lifitegrast, an investigational treatment for dry eye disease, the company announced in a press release.Shire resubmitted the application in response to a complete response letter in which the FDA requested an additional study. In the resubmission, Shire included data from OPUS-3, a phase 3 safety and efficacy trial. The primary endpoint of OPUS-3 was patient-reported improvement in dry eye symptoms.