Positive data for BTG's Varisolve

UK specialist health care firm BTG (LSE: BGC) has announced the successful outcome of VANISH-2, the first of two US pivotal Phase III studies comparing the safety and efficacy of Varisolve (polidocanol endovenous microfoam (PEM)) with placebo in patients with symptomatic and visible varicose veins and saphenofemoral junction incompetence.

Both pivotal Phase III studies are fully recruited, and all patients have been treated, reached the primary endpoint and are in long-term follow-up. The reported study met all primary, secondary and tertiary efficacy endpoints.

Patients treated with PEM (0.5% or 1.0% dose concentrations) demonstrated a statistically-significant improvement in symptoms, the study primary endpoint as measured by the VVSymQ score, compared with patients who received placebo (p < 0.0001). The VVSymQ score is a patient-reported outcome measure of varicose vein symptoms developed and validated by BTG in accordance with FDA guidelines. The study's co-secondary endpoint, improvement of appearance as measured by both a patient-reported outcome (PA-V3) and by a blinded independent panel review of photographs (IPR-V3), was also met. Patients treated with PEM (0.5 or 1.0% dose concentrations) reported a statistically significant improvement in appearance in both the PA-V3 and IPR-V3 scores compared with patients who received placebo (p < 0.0001 and p < 0.0001, respectively).