SARcode begins second phase 3 study for new dry eye therapy

SARcode Bioscience Inc., a privately held biopharmaceutical company, has enrolled the first subject of a second phase 3 clinical efficacy study of lifitegrast ophthalmic solution 5.0%, according to a company press release.

The study, named OPUS-2, will assess the efficacy and safety of lifitegrast in the treatment of dry eye disease and include approximately 700 subjects who will be randomized to receive lifitegrast or placebo twice daily over 12 weeks. The co-primary endpoints of the study are inferior corneal fluorescein staining score and eye dryness, the release said.

Lifitegrast has been studied in more than 900 subjects to date and has demonstrated statistical significance in several signs and symptoms of dry eye disease, according to the release.

In the first phase 3 study, dose-dependent improvements were observed in both corneal and conjunctival staining, key indicators of ocular surface health.

The ophthalmic solution also improved eye dryness and ocular discomfort, the two most commonly reported symptoms of dry eye, according to the release.

Lifitegrast was well tolerated and there were no unexpected or serious ocular adverse events. The most commonly reported ocular adverse events were irritation and pain upon initial instillation of lifitegrast; they were generally mild and transient in nature, said the release.

The results from OPUS-1 and OPUS-2, along with results from an ongoing year-long safety study called SONATA, will support a planned New Drug Application, the release said.