BTG's Varisolve meets VANISH-1 endpoint

BTG plc (LSE:BGC) said Varisolve met the primary endpoint of improving patient-reported varicose vein symptoms from baseline to week eight vs. placebo in the Phase III VANISH-1 trial to treat varicose veins. Varisolve also met the secondary endpoints of improving varicose vein appearance vs. placebo as measured by both a patient-reported outcome (PA-V3) and a blinded central independent photography review (IPR-V3). The double-blind, U.S. trial enrolled 284 patients with symptomatic and visible varicose veins and saphenofemoral junction incompetence. In January, BTG said Varisolve met the same primary endpoint in the Phase III VANISH-2 trial. By year end, BTG plans to submit an NDA to FDA for the polidocanol endovenous microfoam ( PEM) to treat symptoms and appearance of varicose veins. ...