logo
Share SHARE
FONT-SIZE Plus   Neg

BTG Reports Positive Data From First US Phase III Trial Of Varisolve

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Internet access is growing worldwide, but there is still a long way to go before the entire world is completely wired, a study from the Pew Research Center has found. The study also noted that men have greater access to the Internet than women in many nations. Backtracking on its early announcements on digital privacy, WhatsApp is planning to share member information, phone numbers and analytical data with Facebook, to make revenue from the platform. Discount retailers Dollar Tree Inc. and Dollar General Corp. both reported results for the second quarter that missed analysts' expectations. Looking ahead, Dollar Tree also forecast revenue for the third quarter below analysts' estimates and lowered its full-year revenue outlook. Shares of both companies are falling in pre-market activity.
comments powered by Disqus
Follow RTT