BTG Plc (BGC.L) announced the successful outcome of VANISH-1, the second and final US pivotal Phase III trial of Varisolve (polidocanol endovenous microfoam (PEM)) as a potential treatment for patients with saphenofemoral junction incompetence and symptomatic and/or visible varicose veins. All end points were met with all active PEM concentrations with a high degree of statistical significance, the company said.
Patients treated with PEM showed a statistically significant improvement in symptoms, the primary endpoint, versus patients who received placebo. The co-secondary endpoints of improvement in appearance in PEM-treated patients compared with patients who received placebo, as measured by both a patient-reported outcome and by a blinded independent panel review of photographs, were also met.
In addition, 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-QOL/Sym 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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