Varisolve (BTG) data for Varicose Veins published
Results from VANISH-2, the first of two US pivotal Phase III trials of Varisolve (polidocanol endovenous microfoam), from BTG, for patients with Varicose Veins, have been published in Phlebology. Data from the study indicate that Varisolve provides a clinically meaningful benefit in treating symptoms and appearance in patients with Varicose Veins caused by SFJ reflux. The study achieved all primary, secondary and tertiary efficacy endpoints in patients with vein diameters ranging from 3.1 to 19.4 mm.
BTG submitted an NDA to the FDA in April 2013. See: "The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence" Ken Todd et al. Phlebology July 17, 2013 doi:10.1177/0268355513497709