Shire plc SHPG announced that the FDA has acknowledged the receipt of the company’s New Drug Application (NDA) for its pipeline candidate, lifitegrast.

Lifitegrast is being developed for the treatment of the signs and symptoms of dry eye disease in adults.

We remind investors that Shire had originally submitted the NDA for lifitegrast to the FDA in Feb 2015. In Apr 2015, the FDA granted priority review designation to the candidate. However, in Oct 2015, the agency issued a complete response letter (CRL) to Shire’s NDA on lifitegrast, and requested an additional clinical study and more information related to product quality.

Consequently, the company resubmitted the NDA. This time, the FDA has determined that the resubmission was adequate and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of Jul 22, 2016.

The NDA includes data from five clinical trials, including one phase II study, three phase III safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3), and one long-term (one year) phase III safety study (SONATA).

The approval of lifitegrast will give a significant boost to Shire’s efforts to build an ophthalmology unit. Currently approved treatments for dry eye disease include Restasis by Allergan AGN.

Over the last few years, Shire has built a deep pipeline in ophthalmology comprising early-, mid- and late-stage candidates gained through organic growth and the strategic acquisitions of Foresight Biotherapeutics, SARcode Bioscience, Premacure AB and BIKAM Pharmaceuticals.

Consequently, Shire’s ophthalmic pipeline currently includes candidates for the potential treatment of dry eye disease (lifitegrast), infectious conjunctivitis (SHP640), retinopathy of prematurity (SHP607), autosomal dominant retinitis pigmentosa, and glaucoma.

Shire carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Corcept Therapeutics CORT and Pacira Pharmaceuticals PCRX. Both of these companies sport a Zacks Rank #1 (Strong Buy).

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