BTG Varisolve Phase III trial meets efficacy endpoints
BTG has reported positive data from first of two US pivotal Phase III studies comparing the safety and efficacy of Varisolve (polidocanol endovenous microfoam (PEM)) with placebo.
The VANISH-2 has evaluated the safety and efficacy of Varisolve in patients with symptomatic and visible varicose veins and saphenofemoral junction incompetence.
The study met all primary, secondary and tertiary efficacy endpoints.
Patients treated with PEM have 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 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.
The three tertiary endpoints, response to treatment, change in the Venous Clinical Severity Score and Quality of Life as measured by the modified VEINES-Sym/QOL questionnaire, were significantly better for patients treated with PEM.
The safety profile of PEM was consistent with previous clinical studies.
BTG CEO Louise Makin said they look forward to the results of the second pivotal Phase III trial, VANISH-1, and to the results of study VV017 in which Varisolve is used following heat ablation.
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