Anika Therapeutics trial of Hyalofast missed co-primary endpoints

Anika Therapeutics (ANIK) announced topline results from its U.S. pivotal clinical trial of Hyalofast. Enrollment for this trial was completed in 2023 and the results announced follow the recently completed, evaluator-blinded two-year follow-up period post-treatment. While Hyalofast demonstrated consistent improvements in treated patients across all measures of pain and function relative to microfracture, the study did not meet its pre-specified co-primary endpoints. The study was likely impacted by both a higher subject dropout rate in the microfracture arm and missed visits during COVID. This resulted in missing data, which reduced the evaluable sample size and complicated the statistical analysis. Hyalofast exhibited a comparable safety profile when compared to microfracture following the initial effects of the differences in surgical procedure, supporting a favorable benefit-risk profile for Hyalofast. Anika plans to file the third and final PMA module in the second half of 2025 and seek approval from the FDA. The third module will include ongoing additional post-hoc analyses including consideration of additional endpoints previously accepted by the FDA for cartilage repair product approvals. Anika expects that the FDA will consider these additional post-hoc analyses and the additional data from outside the U.S. as part of its review of the PMA submission under its Breakthrough Device Designation, but whether these analyses are sufficient to support approval will be a review issue.