FDA Approves Expanded 26-week Efficacy Claim for Gel-One to Knee OA Pain

By Julie A. Vetalice

Zimmer Biomet announced FDA approval of an expanded 26-week efficacy claim for single-injection Gel-One® Cross-linked Hyaluronate viscosupplement for the treatment of knee pain associated with osteoarthritis (OA).

The formula requires a single 3 mL injection to complete the treatment course. In late 2015, it received FDA approval for repeated use, presenting an option for longer-term OA treatment.

Zimmer Biomet has distributed the product in the U.S. on behalf of Seikagaku since 2013, and it remains a consistently-cited driver of growth for Zimmer Biomet revenue. The two companies also partner on U.S. distribution of VISCO-3, a 3-injection hyaluronic acid-based viscosupplement to treat knee OA pain.

Sources: Zimmer Biomet, Inc.; ORTHOWORLD Inc.


Product Labels: Viscosupplement

Tags: Trial/Study