Fidia Introduces Hymovis at AAOS Annual Meeting

Fidia Farmaceutici S.p.A. and its wholly-owned subsidiary, Fidia Pharma USA Inc., introduced Hymovis (high molecular weight viscoelastic hyaluronan) last week at the American Academy of Orthopaedic Surgery 2016 Annual Meeting in Orlando, Fla.

Hymovis is described by the company as a next-generation of HA-based intra-articular (IA) therapy used to treat pain in knee osteoarthritis patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics. The product has a shorter treatment cycle of only two intra-articular injections as compared to many other IA HA viscosupplement regimens to provide pain relief for patients.

Scientists from Fidia Farmaceutici S.p.A. and a research group led by Dr. Lawrence Bonassar, professor in the Meinig School of Biomedical Engineering at Cornell University, worked together to verify the optimal lubricating characteristics of the HA derivative. Hymovis was bioengineered using a proprietary process that results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid in human joints. The formulation allows the molecule to recover its original structure, even after repetitive mechanical stress. Due to reversible hydrophobic interactions, the non-crosslinked Hymovis has increased elasticity, viscosity and residence time in the joint. “Lots of data exist linking the fact that joint lubrication is compromised after a knee injury,” Bonassar told Orthopedic Design & Technology. “The loss of HA, damage to HA leaves the joint more vulnerable to damage. We were looking to achieve better duration in the joint without losing biocompatibility. The fact that Hymovis is made without crosslinking increases its ability to stay in the joint for an approved length of time.”

Worldwide, hyaluronic acid-based intra-articular injections are used to treat knee pain due to osteoarthritis, and these injections have been recognized for knee osteoarthritis treatment. The U.S. Food and Drug Administration’s Center for Devices and Radiological Health gave premarket approval to Hymovis on Aug. 28, 2015. The product will be rolled out this month, Bonassar and his colleagues said.

“Hymovis represents an important new treatment option for orthopedic surgeon/sports medicine physicians and their patients; particularly those who are active, high-demand patients with knee osteoarthritis pain,” said Clarence L. Shields, M.D., an orthopedic surgeon with the Kerlan-Jobe Orthopaedic Clinic in Los Angeles, Calif.

“The launch of Hymovis builds on our success with our flagship product Hyalgan. With both of these products in our portfolio, we are positioned to provide the solutions for the broad range of patients with pain in osteoarthritis of the knee,” noted Fidia Pharma USA Inc. President Aldo Donati.

Parsippany, N.J.-based Fidia Pharma USA Inc. is a wholly-owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., a developer and manufacturer of hyaluronic acid founded in 1946. Its products are used in the biomedical field, in applications such as rheumatology, orthopedics, surgery, wound care, tissue repair and dermo-aesthetics. Fidia Farmaceutici is part of the P&R Holding Group, based in Italy. P&F operates facilities in Abano Terme (Padua) and Noto (Sicily).