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Insite Vision Inc Announces Top-line Results From tDOUBle Phase 3 Clinical Study For Treatment Of Moderate-To-Severe Blepharitis


Tuesday, 23 Jul 2013 04:05pm EDT 

Insite Vision Inc announced top-line clinical results from the DOUBle Phase 3 clinical trial of AzaSite Plus and DexaSite for the treatment of moderate-to-severe blepharitis. AzaSite Plus and DexaSite did not meet the primary endpoint of complete resolution of all clinical signs and symptoms of blepharitis. AzaSite Plus and DexaSite did demonstrate statistically significant improvements in the clinical signs and symptoms at Day 15. The results of this multi-product Phase 3 study evaluating the treatment of blepharitis further reinforce the emerging clinical viewpoint that blepharitis is a chronic and persistent disease that may require a different approach based on clinically achievable and meaningful improvement rather than a "cure" that is sought for an acute disease. This finding is consistent with the views of an increasing number of clinicians with respect to blepharitis. InSite Vision has scheduled a meeting with the U.S. Food and Drug Administration (FDA) on August 19, 2013 to review the overall results of the DOUBle Phase 3 study. 

Company Quote

0.305
0.0050 +1.67%
22 Aug 2014