Ocugen announced the decision to discontinue the Phase 3 trial of OCU300 for ocular Graft vs. Host Disease (oGVHD). The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. The study was not stopped based on safety concerns. Ocugen will analyze the full data when it is available.
The randomized, placebo-controlled, double-masked, multicenter phase 3 study planned to enroll 60 subjects to receive either Brimonidine Nanoemulsion Eye Drops 0.18% or ophthalmic buffered saline (placebo). The co-primary endpoints were 1) Validated Bulbar Redness (VBR), measured between baseline and 12 weeks of treatment, assessing ocular redness based on a 100-point scale measuring change in appearance, and 2) score on the 10-point Visual Analog Scale (VAS) between baseline and 12 weeks of treatment, showing measured change in ocular discomfort intensity.
About OCU300OCU300 consists of an improved 0.18% ophthalmic nanoemulsion of brimonidine tartrate, an FDA-approved drug with established safety for ocular...
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