Phase III OPUS 3 study of lifitegrast successful in treatment of dry eye disease- Shire plc

Shire plc announced positive topline results from OPUS-3, a phase III efficacy and safety study of lifitegrast versus placebo. These data showed OPUS-3 met the primary endpoint of significantly improving patient-reported symptoms of dry eye disease from baseline to day 84 (p=0.0007). Additionally, OPUS-3 met the secondary endpoints of symptom improvement from baseline to days 14 and 42 (p<0.0001 for both endpoints).

Shire plans to use these data as part of the re-submission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016.

OPUS-3 compared lifitegrast to placebo administered twice daily for 84 days (12 weeks) in patients with dry eye, a recent history of artificial tear use within 30 days of study entry and an eye dryness score (EDS) more than 40. Lifitegrast met the single primary endpoint for patient-reported symptoms of eye dryness (mean change in Eye Dryness Score from baseline to week 12) (treatment difference of 7.16 [95% CI], 3.04, 11.28; p=0.0007). In OPUS-3, lifitegrast met the secondary endpoints of symptom improvement at Days 14 and 42 (treatment difference (95% CI) 7.85(4.33, 11.37) and 9.32 (5.44, 13.20) respectively, (p<0.0001)). OPUS-3 topline results replicated the co-primary symptom endpoint of OPUS-2, a phase III efficacy and safety study (p<0.0001). OPUS-2 did not meet the co-primary endpoint for the sign of inferior corneal staining score, (p=0.6186).

Comment: The results from OPUS-3, where lifitegrast demonstrated symptom improvement as early as two weeks, provide compelling efficacy data that contribute to the totality of evidence from the lifitegrast clinical development program, with more than 2,500 patients.Shire believes the data from OPUS-3 will satisfy the FDA’s request for an additional clinical study.