Venous Leg Ulcer Registry Shows Promising Results for Varithena® Use in Wound Healing

Published

BOTHELL, WA, April 29, 2019 /PRNewswire/ -- BTG plc (LSE: BTG), the global specialist healthcare company, today highlighted the VIEW VLU Registry interim study results, presented at the International Vein Congress in Miami, Florida. The interim findings confirm that Varithena® polidocanol injectable foam 1% shows promise in increasing the rate of wound healing.

The VIEW VLU Registry is a multi-center, open-label registry, designed to collect data from up to 200 patients with Venous Leg Ulcers (VLU) from 40 sites across the US and Canada. Patients enrolled have great saphenous vein (GSV) and/or anterior accessory saphenous vein (AASV) incompetence resulting in one or more VLUs.

The interim results consisted of 54 venous leg ulcers in 50 patients with mean vein perimeter at baseline of 10.86 ± 9.87 cm (max of 48.3 cm) and mean wound age of 27.5 weeks. The study demonstrated 46% of wounds healed at three months post-treatment with a mean time to wound closure of 76 days and median reduction in wound perimeter of 2.0mm/wk for the first 12 weeks of healing. Additional results from the interim analysis included a Numeric Pain Rating Scale (NPRS) score decrease from 4.2 at baseline to 2.1 at three months and VLU recurrence reported in five out of 35 patients within a mean of 127 days post-closure. No adverse events were reported in this study.  In the pivotal trials with Varithena, the three most observed AEs were pain/discomfort in extremity (16.8%), retained coagulum (16.1%) and injection site hematoma or pain (15.4%).

"The interim VIEW results are very encouraging with regard to use of Varithena® for treatment of Venous Leg Ulcers," said Dr. Michael Shao of Swedish Covenant Hospital in Chicago, IL. "VLUs represent a quality of life burden for individual patients and an economic burden for our society, with direct and indirect treatment costs amounting to more than $2.5 billion annually1 and more than 2 million work days lost annually.  We are constantly trying to improve the standard care for patients with VLUs by finding new treatments that are effective both in healing VLUs and in improving the quality of life for our patients.  The results we have seen thus far with Varithena® are very exciting."

The Varithena® procedure is a minimally invasive procedure, eliminating the need to use tumescent anesthesia or strip veins. Patients with a history of prior failed vein therapies have proven to benefit from Varithena® along with patients with typically challenging anatomy such as tortuous or large veins. A study published recently in the Journal of Vascular Surgery demonstrated a 94%2 closure rate following Varithena® treatment in the GSV.

About Varithena®

Varithena® (polidocanol injectable foam) 1% is a prescription medicine used to treat varicose veins caused by problems with the great saphenous vein (GSV) and other related veins in the leg's GSV system. Varithena® helps improve the symptoms of heaviness, achiness, swelling, throbbing, itching (HASTI® symptoms) related to or caused by varicose veins, and the appearance of varicose veins. Treatment is a nonsurgical procedure (no incision is required). Treatment usually takes less than one hour and patients may resume light activities as quickly as the same day of treatment. For further information, please visit www.varithena.com.

IMPORTANT SAFETY INFORMATION
The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with the underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately. Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®.

About BTG

BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer and vascular conditions. BTG's Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.

For further information contact:

BTG
Andy Burrows, VP Corporate & Investor Relations
+44-(0)-20-7575-1741; Mobile: +44-(0)-7990-530-605

Chris Sampson, Corporate Communications Director
+44-(0)-20-7575-1595; Mobile: +44-(0)-7773-251-178

References

1.  "Management of Venous Ulcer Disease," 12 November 2010. BMJ 2010;341:c6045.

2.  Deak ST. Retrograde Administration of Ultrasound-guided Endovenous Microfoam Chemical Ablation (UMCA, Varithena®) for the Treatment of Superficial Venous Insufficiency. J Vasc Surg Venous Lymphat Disord 6:477-484, 2018.

In a single center retrospective review of 250 patients with C2-C6 CVI, complete elimination of venous valvular reflux, vein closure and symptom improvement was documented in 94.4% of patients. Two patients experienced asymptomatic DVTs, one experienced a common femoral vein thrombus extension and four experienced superficial venous thrombi, accompanied by minor discomfort. This information supplements the data from the VANISH-1 and VANISH-2 trials, where the more stringent criteria of "duplex response" (elimination of reflux through the SFJ and/or complete occlusion of all incompetent GSV and major accessory veins at baseline) was evaluated. In VANISH-1 and VANISH-2, patients in the Varithena 1.0% group reported an 80.4% and 86.2% response to treatment, respectively

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