Company projects filing for FDA approval by year end.
BTG reported positive data from the first of two pivotal Phase III studies evaluating Varisolve® (polidocanol endovenous microfoam (PEM)) in patients with symptomatic and visible varicose veins and saphenofemoral junction incompetence. The firm said it remains on track to file for regulatory approval of the treatment in the U.S. by the end of 2012, if additional ongoing trials are successful.
The placebo-controlled 1,500-patient Vanish-2 study met all its primary, secondary and tertiary efficacy endpoints. The primary endpoint was measured by the VVSymQ™ score, a patient-reported outcome measure of varicose vein symptoms, which was developed by BTG in accordance with FDA guidelines. The Phase III Vanish-1 study, and a separate study (VV017) evaluating Varisolve after heat ablation, are both due to report during the first half of 2012.
A European Phase III clinical trial showed that 90% of patients treated with PEM had no reflux in the great saphenous veins (GSV) after three months and fewer than 10% of patients had recurrence at one year.
The PEM drug/device combination generates a Co2/O2 polidocanol endovenous microfoam, and is injected into the incompetent vein under ultrasound guidance. On administration the treatment displaces blood and then the polidocanol ablates the inner lining of the vein wall, causing the vein to close. BTG says if Varisolve is approved it will be the first nonsurgical, comprehensive treatment for varicose veins above and below the knee.