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# Shire Resubmits NDA for Dry Eye Drug
- URL: https://www.fdaweb.com/shire-resubmits-nda-for-dry-eye-drug/
- Published: 2016-01-25T12:00:00.000Z
- Updated: 2026-09-15T02:30:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134543

> Shire has resubmitted an NDA for lifitegrast for treating signs and symptoms of dry eye disease. The submission includes data from a recent study called OPUS-3, a Phase 3 efficacy and safety study of lifitegrast versus placebo. The data, according to the company, showed OPUS-3 met the primary endpoint of significantly improving patient-reported symptoms of dry eye disease from baseline to day 84 (p=0.0007). Additionally, OPUS-3 met the secondary endpoints of symptom improvement from baseline to days 14 and 42.  
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> In October, FDA issued Shire a complete response letter requesting an additional clinical study before granting approval. The agency also requested more information related to product quality, which Shire says was included in the resubmission.  
>  
> Shire says lifitegrast is a novel small-molecule integrin inhibitor that binds to the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand ICAM-1 (intercellular adhesion molecule-1), which is over-expressed in corneal and conjunctival tissues in dry eye disease. The company says the LFA-1/ICAM-1 interaction helps form immunological synapses resulting in T-cell activation and migration to target tissues.  
>  
> The NDA was originally based on four clinical trials of more than 1,800 patients, according to the company.