Development

Product Information

We’re developing Varisolve^® (polidocanol endovenous microfoam (PEM)) as (1) a first line treatment for incompetent great saphenous veins (GSV) and associated varicosities, above and below the knee and (2) for use alongside endovenous thermal ablation.

In the US alone over 40 million patients suffer from varicose veins.¹ Most sufferers opt not to have their veins treated, as current treatments require either the surgical removal of the vein or insertion of a catheter. As potentially the first approved drug, PEM could transform this underserved market by making varicose vein treatment more acceptable.

PEM has a controlled density, consistent bubble sizes, and proprietary gas mix that makes it a simple and comprehensive treatment for symptomatic and aesthetic varicose veins. A European Phase III clinical trial showed that 90% of patients treated with PEM had no reflux in the GSV at 3 months and fewer than 10% of patients had recurrence at 1 year. Patients can generally return to work or their usual activities the same day they are treated, and cosmetic results after PEM treatment are apparent at 6 weeks.¹

Recruitment was completed several months ahead of schedule in August 2011 into three Phase III trials of PEM, an experimental treatment for great saphenous vein (GSV) incompetence. VANISH-1 and VANISH-2 have relief of symptoms as the primary endpoint and improvement in appearance as the secondary endpoint. Study VV017 is designed to support approval for PEM to be used alongside heat ablation of the GSV to treat those vein segments not dealt with by the ablation procedure.

In January 2012 we announced the successful outcome of VANISH-2, the first of two US pivotal Phase III studies comparing the safety and efficacy of PEM with placebo in patients with symptomatic and visible varicose veins and saphenofemoral junction incompetence. The study met all primary, secondary and tertiary endpoints.

Data from the remaining two Phase III studies (VANISH-1 and VV017) are also expected to be available in H1 2012, leading to the submission of a New Drug Application in the US by the end of 2012. We plan to market and sell PEM directly in the US reimbursed sector following approval.

We’re exploring options for partnering in the US aesthetic and rest-of-world markets.

Reference:

1. Wright et al, Phlebology 2006. Vol .21 No. 4

Product Information
More information on this development programme can be accesssed through the link below.
http://www.biocompatibles.com.

Product Information
More information on this development programme can be accesssed through the link below.
http://www.biocompatibles.com.

Product Information
More information on this development programme can be accesssed through the link below.
http://www.biocompatibles.com.

Product Information
More information on this development programme can be accesssed through the link below.
http://www.biocompatibles.com.

Product Information
More information on this development programme can be accesssed through the link below.
http://www.biocompatibles.com.