BTG's varicose vein treatment passes US trials
Pharmaceuticals group BTG says Varisolve, a new treatment for varicose veins, has been successful in VANISH-1, the second and final phase III trial in the US.
Pharmaceuticals group BTG says Varisolve, a new treatment for varicose veins, has been successful in VANISH-1, the second and final phase III trial in the US.
The microfoam, Varisolve, aims to treat the not-easy-to-pronounce "saphenofemoral junction incompetence" which can lead to varicose symptoms.
The success of the VANISH-1 trial follows the positive outcome from VANISH-2, the first pivotal Phase III trial, the results of which were announced at the end of January.
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Investigator Dr Ted King, the National Medical Director of Vein Clinics of America, said: "VANISH-1 and VANISH-2 are extremely rigorous trials that have both shown clear benefits ... in patients with symptomatic varicose veins, as assessed by the patients and their treating physicians and in a randomised, controlled manner."
Based on the successful outcome of these two pivotal Phase III trials, BTG intends to submit a New Drug Application this year in the US, seeking approval of Varisolve (polidocanol endovenous microfoam, or PEM) as a comprehensive treatment for symptoms and appearance of varicose veins.
The market wasn't terribly impressed, at 08:11 the stock had fallen 0.5% although since the start of the year the shares have gained 22%.
BS
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