Shire's (SHPG) Dry Eye Disease Drug Xiidra Gets FDA Nod

Shire plc (NASDAQ:SHPG) received a major boost when the FDA approved its ophthalmology drug Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease (DED) in adults.

Per the company, Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition. Approximately 16 million adults in the U.S. are diagnosed with dry eye disease, underscoring significant need for treatments in this field. Shire expects to launch the drug in the third quarter of 2016.

However, the road to Xiidra’s approval has been bumpy. In Oct 2015, the FDA issued a complete response letter to the company’s new drug application (NDA) for the drug. The agency had requested for an additional clinical study to support the company’s NDA.

Thereafter, Shire announced positive top-line results from a phase III study, OPUS-3. The study met both the primary and secondary endpoints. It compared Xiidra to placebo administered twice daily for 84 days in patients suffering from DED, who have a recent history of artificial tear use within 30 days of study entry and an eye dryness score of 40.

The study also evaluated the safety and tolerability of the drug based on the occurrence of treatment-emergent adverse events. The safety and tolerability profile of the drug was consistent with results from previous studies. Consequently, Shire resubmitted the NDA with the new data in Jan 2016.

Our Take

We note that Shire has a solid presence in the rare disease markets. The approval of Xiidra will enable the company to build a strong ophthalmology franchise as well. The DED market represents significant potential.

The company has a deep pipeline in ophthalmology comprising early-, mid- and late-stage candidates gained through organic growth and strategic acquisitions. Over the last three years, the company has made several acquisitions, including those of Foresight Biotherapeutics, SARcode Bioscience, Premacure AB and Bikam Pharmaceuticals. These transactions added key early-, mid- and late-stage candidates to Shire’s ophthalmic pipeline.

We remind investors that Shire’s ophthalmic pipeline currently includes candidates for infectious conjunctivitis, retinopathy of prematurity, autosomal dominant retinitis pigmentosa and glaucoma.

Shire currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the healthcare sector include Pfizer, Inc. (NYSE:PFE) , Roche Holding (SIX:ROG) AG (OTC:RHHBY) and Johnson & Johnson (NYSE:JNJ) . While Pfizer sports a Zacks Rank #1 (Strong Buy), Roche and Johnson & Johnson carry the same rank as Shire.