BTG Announces 1-Year Data From VANISH-2

February 21, 2014—BTG International Inc. (West Conshohocken, PA) announced that 1-year data on its Varithena polidocanol injectable foam were presented by Kenneth Todd, MD, at the 26th Annual Meeting of the American Venous Forum in New Orleans, LA. Dr. Todd is an American College of Phlebology Committee Member from the Southeast Vein and Laser Center and a Principal Investigator for VANISH-2, one of two pivotal trials studying Varithena.

Varithena received US approval from the US Food and Drug Administration (FDA) in November 2013 for the treatment of varicose veins caused by saphenofemoral junction incompetence. Commercial launch of the product in the United States is planned for the second quarter of this year, said BTG in its press release.

According to the company, VANISH-2 is studying patients with symptomatic and visible varicose veins, caused by saphenofemoral junction incompetence, who were treated with Varithena. The 1-year results indicate that treatment with Varithena led to clinically meaningful and ongoing improvements in symptoms, as measured by the VVSymQ score.

The VVSymQ electronic daily diary is a patient-reported outcomes instrument that measures the burden of varicose vein symptoms and was developed in accordance with FDA guidelines. The VVSymQ score measures the five most relevant symptoms to patients: heaviness, achiness, swelling, throbbing, and itching. The scores range from 0 to 25, with 0 representing no symptoms, and 25 representing all five symptoms experienced all of the time.

At baseline, 12% of patients treated with Varithena reported a VVSymQ score of 3 or less, whereas 84% of patients reported a VVSymQ score of 3 or less at 1 year. The mean improvement in VVSymQ score relative to baseline was 4.7 points at 8 weeks and 6.2 points at 1 year.

Continued improvement at 1 year was also shown in: (1) appearance, as measured by a blinded independent panel review of photographs and a patient-reported outcome instrument; (2) disease severity, as measured by the Venous Clinical Severity Score; and (3) varicose vein–related quality of life, as measured by the Venous Insufficiency Epidemiological and Economic Study−Quality of Life score.

BTG noted that serious adverse events reported in the long-term follow-up period were typical of those expected for the patient population studied and were unrelated to treatment.

“The 1-year data from VANISH-2 are important because they show that clinically meaningful improvements in symptoms and appearance are sustained 1 year after treatment,” said Dr. Kenneth Todd, MD. “Ongoing improvements as shown in the VANISH-2 analysis support the recent FDA approval of Varithena, which offers a new treatment option for patients with varicose veins.”