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Ocular Therapeutix™ Announces Topline Results for Phase 2 Clinical Trial of OTX-CSI for the Treatment of Dry Eye Disease Did Not Meet Primary Endpoint
BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix, Inc. (Nasdaq:OCUL), a biopharmaceutical company focused on the formulation, development, and
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":" BEDFORD, Mass.--(BUSINESS WIRE)--\nOcular Therapeutix, Inc. (Nasdaq:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced topline results from its Phase 2 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).\n\nThe Phase 2, U.S.-based, randomized, double-masked, multi-center, vehicle-controlled clinical trial of OTX-CSI was designed to evaluate safety, tolerability, durability, and efficacy of two different formulations of OTX-CSI by measuring signs and symptoms of DED in 140 subjects treated in both eyes over approximately 16 weeks (a 12-week study period, with an additional 4-week safety follow-up). In the Phase 2 clinical trial, OTX-CSI was administered to 147 subjects with DED at 15 sites in the U.S. The four groups evaluated in this study were: OTX-CSI for a shorter duration (2-3 months formulation-F1, n=42), OTX-CSI for a longer duration (3-4 months formulation-F2a, n=40), vehicle insert for a longer duration (3-4 months formulation-F2b, n=43) and vehicle insert for a very short duration (1 week formulation-F3, n=22).\n\nThe 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 the Schirmer’s Test. Change from baseline (improvement) in mean Schirmer’s Test scores for the four groups were as follows: OTX-CSI F1: 1.98 mm, OTX-CSI F2a: 1.91 mm, Vehicle F2b: 2.24 mm and Vehicle F3: 3.08 mm.\n\nThe study did show an improvement compared with baseline in signs of dry eye disease as measured by total corneal fluorescein staining (CFS) and symptoms of dry eye disease as measured by the visual analogue scale (VAS) eye dryness in subjects treated with the OTX-CSI insert (both formulations) starting as early as two weeks after insertion and continuing over the 12 weeks study period. These improvements were not statistically significant compared with vehicle insert (both formulations) for either CFS or VAS eye dryness (severity and frequency) at 12 weeks.\n\nOverall, the OTX-CSI insert (both formulations) was generally observed to have a favorable safety profile and was well tolerated. There w...