RenehaVisTM obtains 12-month efficacy approval for knee pain and stiffness due to degenerative changes of the synovial joint

Following the April 2012 Drug Tariff entry for its two lead products, SportVisTM (approved for tennis elbow and ankle sprain) and RenehaVisTM, LSP Bio further announced that its new generation, dual molecular weight, dual action Hyaluronic Acid (HA) based product, RenehaVisTM, has received a highly significant extension to its existing Class 3 CE approval.

“We are delighted to officially confirm that the indicated efficacy of RenehaVisTM has been extended from 4 to 12 months for treatment of knee pain and stiffness in patients with degenerative changes of the synovial joint such as osteoarthritis” said Mark Lewis, Director at LSP Bio. “This is a highly significant development in this product sector, confirming the conclusions of the recent 2 year pivotal study that revealed RenehaVisTM to have significantly enhanced efficacy, not just in the speed and magnitude of its impact in knee pain sufferers but also in the durability of that efficacy. Add to that the fact that 17% of the patients did not need to be retreated at 12 months and I think RenehaVisTM can be a serious treatment candidate where patients need a simple treatment schedule that works strongly, quickly, consistently and with a more lasting effect. We also think that due to its pricing, RenehaVisTM will appeal not only to patients but also to UK healthcare providers facing tightening budgets”.

The randomised, double-blind Canadian trial with RenehaVisTM, first unveiled in poster form in Rome at EULAR 2010, is amongst the most extensive of its type in knee osteoarthritis to date. It compared the effects of RenehaVisTM to best available ‘high’ and ‘low’ molecular weight HA products, as well as placebo, in 200 patients with osteoarthritis of the knee over a period of two years.1 The findings reveal that RenehaVisTM treatment provides significant pain reduction after a single treatment when walking compared with typical lower or high molecular weight HA treatments used in other trial arms (P<0.001). Pain reduction, both at rest and during activity, was sustained throughout the two years of the study in that RenehaVisTM patients experienced greater pain relief for up to 52 weeks when retreatment was offered and in approximately 17% of patients one treatment of RenehaVisTM provided pain relief for significantly more than 52 weeks. In addition, RenehaVisTM provided both greater and maximum improvement by the second injection of each treatment, and patients were less likely to need repeat injections compared with the other HAs. Patients were also significantly more satisfied with RenehaVisTM than with the other HA treatments (P<0.005) and they had significantly less need for supplementary pain relief treatment compared to the other arms.

RenehaVisTM is administered via a low volume intra-articular injection into the knee synovial capsule. Although up to three injections can be given at weekly intervals subject to disease severity, the majority of patients in the clinical trial reported maximum pain improvement after just two. Appearing in the ‘Synovial Fluids’ (IXA devices) Drug Tariff class with other single molecular weight HA products, RenehaVisTM is listed at £112 per injection and is approved for treatment and relief of knee pain and stiffness in patients with degenerative changes of the synovial joint such as osteoarthritis of the knee.

1 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. 2 Haq I et al. Osteoarthritis. Postgrad Med J. 2003 Jul; 79(933):377-83.

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