Positive results from two Phase III trials of Varisolve (BTG) as Varicose Vein treatment

Data from VANISH-1 and VANISH-2, the two US pivotal Phase III trials of Varisolve (polidocanol endovenous microfoam), from BTG, show endpoints were met with all therapeutic PEM concentrations for patients with Varicose Veins, compared to placebo (p < 0.0001). In VANISH-2, eighty per cent of patients treated with PEM reported a much or moderate improvement of symptoms, as measured with the novel VVSymQ patient reported outcome (PRO) instrument compared to 20% in the placebo arm. In addition, 85% of patients demonstrated elimination of saphenofemoral junction reflux and/or occlusion of the great saphenous vein and all incompetent veins, as measured by duplex ultrasound compared with 2% in the placebo arm.

In VANISH-1, which focused on the improvement in appearance before and after treatment, 64% of patients treated with active PEM dose concentrations (PEM 0.5%, 1.0% and 2.0%) reported a much or moderately improved appearance eight weeks after treatment compared to 4% in the placebo arm. 79% of treatments resulted in a much or moderately improved appearance as measured by physicians using the IPR-V3 tool compared to 9% in the placebo arm. Data were presented at the 26th Annual Congress of the American College of Phlebology.