LSP Bio today announced the UK launch of two new and innovative Hyaluronic Acid (HA) based products, RenehaVis™ (for osteoarthritis of the knee) and SportVis™ (for ankle sprain and tennis elbow). Both products are CE-mark approved and are also among the very first products fast tracked to 'Innovative Products' status in the new NHS Supply Chain contracts.

"RenehaVis and SportVis are novel HA treatments, both manufactured in the UK, and are supported by strong data from robust clinical studies," said Mark Lewis, Director at LSP Bio. "We are aware that practical clinical experience with other HA products has been inconsistent in the UK. However, early experience elsewhere in Europe allied to our data clearly shows that RenehaVis and SportVis provide significant benefit versus standard or comparative treatment for the three conditions, in efficacy, duration of benefit and also in the high satisfaction levels reported by patients".

According to Elaine Alsop, the NHS Supply Chain's executive buyer, the first innovative products on the Supply Chain list are "an exciting development in our aim to deliver improved care and financial savings."1 With this new initiative, innovative products that once took up to five years to be brought to market should now be available to NHS Trusts much sooner.

"We are very pleased that the NHSSC has reviewed the clinical data and recognises the value and innovation shown to develop two products to meet three clinically challenging conditions," continued Mark Lewis. "Osteoarthritis in the knee is painful and disabling and many thousands of patients are out there suffering daily, waiting for an effective treatment. Some are using treatments which perhaps only help them briefly, but most are taking analgesics to help them retain mobility until some receive surgery. RenehaVis has been developed to provide a more holistic approach than current injectable treatments and ongoing studies show that patients under trial conditions experience relief faster, and for longer, and require less concomitant medication than with comparator treatments. The task is surely to make patients waiting for surgery more comfortable or perhaps in some cases to even delay the need for surgery. "

He added: "SportVis, meanwhile, has been developed as the very first approved treatment for grade 1-2 ankle sprain and clearly enables faster recovery with a reduced chance of recurrence. In addition, it offers a highly promising and effective new treatment for epicondylagia (tennis elbow), again a painful and disabling condition for many where current treatments are often ineffective. We believe that these benefits and others such as reducing concomitant medication use will lead to these products being seen as useful new clinical tools, and we look forward to them being considered for routine adoption both in the NHS and the private sector."

Renehavis and osteoarthritis of the knee

Renehavis is a unique and patented product because it contains two different HAs, one of low molecular weight/high concentration and the other of high molecular weight/standard (lower) concentration, provided in a dual chambered syringe for a combined sequential injection. Osteoarthritis is a condition in which the surfaces of the joints become so damaged that the joint can no longer move smoothly, causing considerable pain and stiffness that interferes with even the simplest tasks of everyday life. Osteoarthritis of the knee may affect up to 2 million people in the UK, is twice as common in women as in men, and is most common in women over the age of 50 years.2

The newly published randomized, double-blind Canadian trial with RenehaVis, first unveiled at EULAR 2010, is amongst the most extensive of its type to date. It compared the effects of different molecular weight HAs in 200 patients with osteoarthritis of the knee over a period of 2 years.3 The findings reveal that RenehaVis treatment provides significant pain reduction when walking compared with typical lower or high molecular weight HA treatments (P<0.001). Pain reduction, both at rest and under activity, was seen at every time point and was sustained throughout the 2 years of the study so that RenehaVis patients were likely to enjoy greater pain relief for up to and even beyond 52 weeks. In addition, RenehaVis provided greater improvement by the second injection, and patients were less likely to need repeat injections compared with the other HAs. Patients were also significantly more satisfied with RenehaVis than with the other HA treatments (P<0.005), and they were significantly less likely to need supplementary pain relief treatment or as much. These patient-focused benefits were clear at all time points up to 2 years, with a very low rate of local adverse events over a long-term follow-up.

"Osteoarthritis is typically chronic and patients need durable treatments. RenehaVis has two HAs, one to lubricate the knee and another to cushion shocks. This dual action is responsible for the speed and durability of the response we saw with RenehaVis in clinical trials," said Dr. Robert J. Petrella, University of Western Ontario, London, Canada. "It is always an added bonus when the pain reduction reported by patients is enough to avoid the need for extra injections and additional analgesia." RenehaVis is administered via an intra-articular injection into the knee synovial capsule. Although up to three injections can be given at weekly intervals, most patients in clinical trials reported improvement after just two.

SportVis and epicondylagia

SportVis is unique due to its main ingredient, STABHA (Soft Tissue Adapted Biocompatible Hyaluronic Acid), which has been designed specifically to interact optimally with soft tissue ligaments and tendons of the elbow and ankle due to its purity profile and biocompatibility. It is administered via a periarticular injection into the site of injury using the fanning technique, which helps to spread SportVis over a large surface area within the injury site to have optimal interactions with the microtears in tendons and torn ligaments. A second injection may be administered a few days later. SportVis offers a novel and effective way of treating both the pain associated with tennis elbow (epicondylagia) and the underlying condition. Epicondylitis is a chronic condition that affects up to 3% of the population4 and is caused by small tears to the muscle fibres in the forearm due to repetitive movements or overuse.

A recent, independent systematic review published in the Lancet5, meta-analysing randomised trials of injectable treatments for tendinopathies such as tennis elbow confirmed the benefit of SportVis. The study noted that SportVis injection was effective in the short, intermediate, and long terms for patients with tennis elbow, with significant differences compared with placebo at all time points (all P<0•0001). No other treatment discussed in the review produced this benefit. The original randomised, double-blind, placebo-controlled study discussed in the Lancet review also showed that patients treated with SportVis experienced significantly less pain both at rest and after grip testing compared with patients who received placebo (P<0.001).6 SportVis recipients were able to return to pain-free and disability-free activity within an average of 18 days and improvements were still evident almost a year after the initial treatment. Very few minor and transient adverse events were reported.

"Only about 1 in 25 people affected by tennis elbow are actually racquet sport players or golfers. It usually affects people with activities or jobs that require strong gripping or repetitive wrist motions, like gardeners or plumbers," said Mark Lewis. "SportVis has an important role to play not only in reducing pain, but in allowing people to regain their capability for normal activities as soon as possible."

SportVis and ankle sprain

Ankle sprain accounts for up to 75% of all musculoskeletal injuries that occur during sporting and daily activities.7 Sprains recur at a rate of approximately 40% in the sporting population. SportVis is the first ever approved treatment for grade 1 and 2 ankle sprains and is administered by up to two peri-articular injections, one as soon after injury as possible, once more serious injury has been ruled out, and the second ideally 48-72 hours later.

Mark Lewis added: "Experience elsewhere in Europe shows that SportVis could have a real role in the improved management of this every day trauma not just for athletes as demonstrated in the most recent long term study,8 but for everyone. In the randomized long term study in injured athletes, SportVis plus RICE (rest, ice, compression and elevation) was compared to placebo injection plus RICE and showed that SportVis enabled patients to return pain-free and disability-free to sports (and daily activities) 6 days faster than the average 17 days recovery period (P<0.05). Satisfaction levels with the treatment were high and long term follow up showed that patients had a significantly reduced rate of ankle sprain recurrence".

1. NHS Supply Chain. Press releases. Available here.

2. Haq I et al. Osteoarthritis. Postgrad Med J. 2003 Jul;79(933):377-83.

3. Petrella RJ et al. Long term efficacy and safety of a combined low and high molecular weight hyaluronic acid in the treatment of osteoarthritis of the knee. Rheumatology Reports 2011;3:e4 (first published

4. Hong QN et al. Treatment of lateral epicondylitis: where is the evidence? Joint Bone Spine. 2004 Sep;71(5):369-73.

5. Coombes BK et al. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67

6. Petrella RJ et al. Management of tennis elbow with sodium hyaluronate periarticular injections. Sports Med Arthrosc Rehabil Ther Technol. 2010 Feb 2;2:4.

7. Wolfe MW et al. Management of ankle sprains. Am Fam Physician 2001 Jan 1;63(1):93-104.

8. Petrella RJ et al. Original research: long-term efficacy

Source:
LSP Bio