by Andrea B. Epstein
According to representatives at BTG plc, manufacturer of varisolve® - the polidocanol endovenous microfoam developed as a first line treatment for incompetent great saphenous veins (GSv) and other varicosities above and below the knee - the company is hoping to launch Phase iii clinical trials in the U.S. to evaluate the product’s longer term efficacy in the first quarter of this year. As noted in the company’s literature, varisolve® microfoam has “a unique controlled density, consistent bubble sizes and a proprietary gas mix that makes it as simple and comprehensive treatment for symptomatic and aesthetic varicose veins.” A european Phase iii clinical trial showed that 90% of the patients treated with varisolve® had no reflux in the GSv at ?
months; fewer 10% showed recurrence at one year.
The U.S. trials are following on the heels of the successful european results. Here, phase ii trials showing product safety have been completed, along with Pilot or Preparatory Phase iii trials to refine dosing andmethodology for the Phase iii efficacy trials which are soon to follow.
The Phase III U.S. trials come with great anticipation from phlebologists and other physicians here who treat venous disease and have followed the european trials, hoping to bring this treatment option to their patients with GSv incompetence. BTG could not share with vein any of the details yet pertaining to the study design, patient numbers or sites for the Phase III trials, as the final methodology – including endpoints and statistical analyses to be undertaken -- is, as of press time for this issue, still under final review by the FDA.
According to BTG’s interim Report for the Six Months ending September 30, 2009, the Phase iii trials could start recruiting patients in Q1 of this year. with this timing, a potential new Drug Application (nDA) could be filed in the U.S. in 2012 with potential FDA approval following in 201?. it is expected that commercial pricing of the product will not be determined until FDA approval; this will also impact the adoption of these treatment in the U.S., where rising health care costs and shrinking reimbursement are becoming an all-too-familiar concern for physicians treating venous disorders.
More in-depth coverage of the upcoming U.S.-based efficacy trials for varisolve® will follow in our Spring issue, when details about this Phase III study are available and the trials are likely underway.