Shire (SHPG) announced positive top-line results from a phase III study, OPUS-2, on dry eye disease candidate lifitegrast.
The multicenter, randomized, placebo-controlled study evaluated the efficacy and safety of 5.0% lifitegrast ophthalmic solution compared to placebo administered twice daily for 84 days in dry eye patients.
It was observed in the trial that lifitegrast met the prespecified co-primary endpoint for the patient-reported symptom of eye dryness.
The phase III development program of lifitegrast consists of three studies – OPUS-1, OPUS-2 and SONATA. After examining the total data from the complete clinical program, Shire expects to discuss the lifitegrast program with regulatory authorities.
Lifitegrast was added to Shire’s pipeline following the acquisition of SARcode in Apr 2013.
Meanwhile, the acquisition of Premacure in Mar 2013 has also added a potential protein replacement therapy, premiplex, for the prevention of retinopathy of prematurity to Shire’s pipeline.
Both these candidates strengthened Shire’s ophthalmology pipeline. We expect the acquisitions of SARcode and Premacure to develop a new business unit in ophthalmology for Shire.
We remind investors that Shire recently announced that it will acquire ViroPharma Inc. (VPHM) for approximately $50 per share or $4.2 billion, in a bid to strengthen its portfolio of rare disease drugs. ViroPharma's lead drug Cinryze is approved in the U.S. for routine prophylaxis against angioedema attacks in adolescent and adults with hereditary HAE. Cinryze complements Shire's Firazyr, indicated for the on-demand treatment of acute HAE attacks.
Shire’s efforts to realign its business structure to drive growth and innovation are noteworthy. The recently announced acquisition of ViroPharma will be a significant boost to the company’s rare disease portfolio and we expect accretion once the acquisition goes through.