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.
Following successful completion of the US Phase II safety study, the FDA has reviewed the study data and confirmed that screening patients for right-to-left cardiac shunts is no longer required under the current study protocol and that deep vein thromboses no longer need to be classified as serious adverse events unless they are life-threatening or cause or prolong hospitalisation.
In late 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 that is 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. A Patient Reported Outcomes (PRO) tool, which measures a patient’s perception of symptom improvement, was also submitted for evaluation.
Comments have been received on the SPA for study VV015 and are being addressed, following which an amended protocol will be submitted. Comments on the SPA for study VV017 and on the PRO tool are awaited. Preparations continue for study VV016, the second pivotal Phase III trial supporting single agent use. Although this trial is not subject to the SPA process, the feedback received on the SPA for study VV015 and on the PRO tool will be incorporated into its design.
In November 2009, BTG announced that while continuing discussions with potential commercial partners, BTG is also considering completing US regulatory development and marketing Varisolve® itself in the US reimbursed sector if the product receives regulatory approval.
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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