Company aims for U.S. regulatory submission of Varisolve by the end of this year.
BTG said it remains on track to support its varicose veins therapy Varisolve® (polidocanol endovenous microfoam; PEM) for approval in the U.S. by the end of the year, following positive data from the second registrational U.S. Phase III study. The placebo-controlled Vanish-1 study evaluated Varisolve in the treatment of 284 patients with saphenofemoral junction incompetence and symptomatic and/or visible varicose veins.
All endpoints were met, including the primary endpoint of statistically significant improvements in symptoms, and co-secondary endpoints of improvement in the appearance of PEM-treated patients. Three tertiary endponts were also statistically improved following Varisolve therapy when compared with placebo. These were response to treatment as determined by duplex ultrasound, change in the venous clinical severity score, and quality of life.
BTG says the Vanish-1 trial data support those of the first Phase III trial, Vanish-2, which were reported in January. “Based on the successful outcome of our two pivotal trails, Vanish-1 and Vanish-2, which met all their endpoints with a high degree of statistical significance, we are on track to submit our U.S. regulatory application by the end of 2012,” remarks Louise Makin, BTG CEO. “We will be seeking the approval of PEM as a comprehensive treatment to improve both the symptoms and appearance of varicose veins.”
PEM is a CO2/O2 polidocanol endovenous mcirofoam, which is injected directly into the incompetent vein under ultrasound guidance. The treatment effectively displaces the blood, enabling the polidocanol to chemically ablate the inner lining of the vein wall, causing it to close. BTG says if approved, PEM will be the first nonsurgical, comprehensive treatment for varicose veins.
