Rottapharm Biotech is developing a platform of innovative agents for intra-articular viscosupplementation in OA. The platform includes a synthetic polymer of vinyl alcohol (polyvinyl alcohol; PVA) named PVA Hydrogel.
PVA is a biocompatible material, widely adopted as a Medical Device for various uses under different forms. Rottapharm Biotech’s PVA Hydrogel is a crosslinked polyvinyl alcohol and an innovative, patented viscosupplementing agent with powerful lubricating properties.
The main favourable characteristic of PVA Hydrogel are:
- high biocompatibility, purity and tolerability profile
- long half-life and no enzymatic degradation, with potentially greater efficacy than hyaluronic acid-based viscosupplements
- competitive manufacturing costs.
Formulated in pre-filled syringes with a nominal content of 2 mL, the product has entered clinical development as a Medical Device for OA symptoms. The proof-of-concept, Phase II clinical investigation is designed as a randomized, parallel group, multicentre study to test the safety and clinical performance over 6 months of a single intra-articular injection of PVA Hydrogel compared with a marketed best in class hyaluronic acid comparator in patients with knee OA.