Ocular Therapeutix said a phase-2 study of its OTX-CSI insert for the treatment of dry-eye disease (DED) missed its primary endpoint of increased tear production.
The US-based clinical trial was designed to evaluate safety, tolerability, durability and efficacy of different OTX-CSI formulations, measuring signs and symptoms of DED in 140 subjects treated in both eyes over a 12-weeks, with an additional four-week safety follow-up.
OTX-CSI was evaluated for 2-3 months using formulation F1 (n=42); 3-4 months using F2a (n=40); plus a vehicle insert for a 3-4 months using F2b (n=43); and vehicle insert for 1 week with formulation F3 (n=22).
The study did not show separation between the OTX-CSI-treated subjects (both formulations) and the vehicle-treated subjects (both formulations) for the primary endpoint of increased tear production at 12 weeks, as measured by Schirmer’s test. Further, results showing improvement compared with baseline in measures of total corneal fluorescein staining and visual analogue scale eye dryness were not statistically significant at 12 weeks.
Ocular Therapeutix said it is disappointed, adding that it will continue to review the data for more information that may inform the development of its programme.
