Sun Pharma Advanced Research Company (SPARC) has reported positive top-line results from its Phase 3 trial for its investigational drug, SDN-037, for the treatment of Inflammation and Pain associated with Ocular Surgery. The trial met its pre-specified primary and secondary objectives, demonstrating that SDN-037 is superior to its vehicle.
The objective of the trial was to assess the efficacy and safety of SDN-037 in clearing the inflammation and pain. To that end, the primary efficacy measure was the proportion of subjects with an anterior chamber cell (ACC) grade of zero on Day 15 (zero inflammation). A statistically significant proportion of patients treated with SDN-037 achieved an ACC grade of 0 versus vehicle with p-values <0.0001 in the Intent-To-Treat population.
SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.
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