Product
Varisolve®
polidocanol endovenous microfoam
Indication
Varicose veins
Phase
Phase III (EU); Phase II (US)
Description
Varisolve® is a polidocanol endovenous microfoam product being developed as a first line treatment for incompetent great saphenous veins (GSV) and associated varicosities, above and below the knee.
Further Information
In the United States alone over 40 million patients suffer from varicose veins. 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 endovenous microfoam, Varisolve® could transform this underserved market by making varicose vein treatment more acceptable.
Varisolve® has a unique 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 Varisolve® had no reflux in the GSV at 3 months and fewer than 10% of patients had recurrence at 1 year.1 Patients can generally return to work or their usual activities the same day they are treated, and cosmetic results after Varisolve® treatment are apparent at 6 weeks.
In October 2009 BTG submitted a request to the US Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) of study VV015, one of two planned pivotal Phase III trials intended to support the approval of Varisolve® as a single agent treatment for moderate to severe varicose veins. Another SPA was submitted in December 2009 for study VV017, a third Phase III trial, designed to support the approval of Varisolve® as an adjunct treatment of varicosities and distal greater saphenous vein (GSV) incompetence in patients with previous proximal GSV ablation. In addition a Patient Reported Outcomes (PRO) tool, which measures a patient’s perception of symptom improvement, was also submitted for evaluation.
Following encouraging discussions, at a recent meeting the FDA gave support to commence the three planned Phase III trials. BTG plans to fund the Phase III trials in the US and to market the product in the US reimbursed sector which it estimates to be worth approximately $250m-$500m.
BTG will continue to explore options for partnering in the US aesthetic and rest-of-world markets.
Please contact our Business Development Team for more information.
1D Wright et al, Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomised controlled trial, Phlebology 2006; 21:180-190.
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