Healthcare company BTG Plc (BGC.L) 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, or 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.
BTG noted that the study met all primary, secondary and tertiary efficacy endpoints. Patients treated with PEM showed a statistically significant improvement in symptoms, the study primary endpoint as measured by the VVSymQ score, compared with patients who received placebo.
The study's co-secondary endpoint, improvement of appearance as measured by both a patient-reported outcome, or PA-V3, and by a blinded independent panel review of photographs, or IPR-V3, was also met. Patients treated with PEM reported a statistically significant improvement in appearance in both the PA-V3 and IPR-V3 scores versus patients who received placebo.
Moreover, the three tertiary endpoints, response to treatment as determined by duplex ultrasound, change in the Venous Clinical Severity Score and Quality of Life as measured by the modified VEINES-Sym/QOL questionnaire, were all statistically significantly better for patients treated with PEM compared to patients who received placebo.
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by RTT Staff Writer
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