Shire plc, of Dublin, presented study results from its pivotal phase III OPUS-2 study investigating lifitegrast (5.0 percent ophthalmic solution) in adults with dry eye disease at the 2014 American Society of Cataract and Refractive Surgery annual meeting. Shire also released top-line results from the prospective, randomized, double-masked, placebo-controlled, long-term (one-year) phase III SONATA safety study. In the OPUS-2 study, Lifitegrast met one of the co-primary endpoints for the patient-reported symptom of improvement in dry eye compared with placebo (p < 0.0001), but did not meet the second co-primary endpoint of the sign of inferior corneal staining (p = 0.6186). Top-line results from the prospective, randomized, double-masked, placebo-controlled SONATA trial indicated no ocular or drug-related serious adverse events. At day 360, analysis of the primary endpoints of ocular and non-ocular adverse events (AEs) showed that ocular AEs occurring in >/= 5 percent of subjects included installation site irritation (15 percent vs. 4.5 percent for placebo), installation site reaction (13.2 percent vs. 1.8 percent for placebo), visual acuity reduced (11.4 percent vs. 6.3 percent for placebo), and dry eye (1.8 percent vs. 5.4 percent for placebo). The most commonly reported non-ocular AE associated with lifitegrast was dysgeusia (altered sense of taste) (16.4 percent vs. 1.8 percent for placebo).

Teva Pharmaceutical Industries Ltd., of Jerusalem, reported positive results from a pivotal phase III study of hydrocodone bitartrate extended-release tablets designed with Teva's proprietary technology providing potential abuse-deterrent properties (CEP-33237). The results showed significant improvement in the treatment of patients' chronic low back pain as measured by both weekly average Worst Pain Intensity and weekly Average Pain Intensity scores. CEP-33237 is an investigational twice-daily, acetaminophen-free hydrocodone formulation in development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.