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Ocular Therapeutix™ Announces Topline Phase 1 Clinical Trial Results of OTX-CSI
OTX-CSI demonstrates improvement in signs and symptoms of Dry Eye Disease BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"\nOTX-CSI demonstrates improvement in signs and symptoms of Dry Eye Disease\n\n 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 Phase 1 clinical trial results of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).\n\n“The results of the Phase 1 clinical trial provide an early look at the safety, tolerability, durability, and potential biological activity of OTX-CSI,” said Michael Goldstein, MD, MBA, Chief Medical Officer. “While the study enrolled a small number of subjects and was open-label, the results seen thus far are very encouraging. Our novel intracanalicular insert delivered a consistent dose of cyclosporine without preservatives over approximately 12 weeks, in a manner we believe to be both less irritating to the ocular surface and also faster acting than current standard of care eye drop therapies. We believe that if approved by the FDA, OTX-CSI has the potential to become a highly differentiated treatment that would provide significant benefit to patients with dry eye disease and allow them a hands-free alternative to current therapies.”\n\nThe Phase 1, U.S.-based, open label, single-center clinical trial was intended to evaluate safety, tolerability, durability, and biological activity of OTX-CSI by measuring signs and symptoms of DED in five subjects (10 eyes) over approximately 16 weeks (a 12-week study period, with an additional 4-week safety follow-up). In the clinical trial, OTX-CSI was administered by a physician as a bioresorbable intracanalicular insert to both eyes in five subjects with DED. All subjects completed the 16-week study period with no drop-outs. No serious adverse effects were reported. The inserts were observed to be well-tolerated, and there were no adverse events of stinging, irritation, blurred vision or tearing reported or observed. Tear production as measured by the Schirmer’s test improved from mean values of 4.2 mm at baseline to 8.2 mm at Week 12. One of five (20%) subjects had a ≥ 10mm increase in Schirmer’s score at Week 12 from baseline. Subjects treated with OTX-CSI demonstrated an improvement in signs of DED as measured by corneal total fl...