THANK YOU to the FOP community members around the world who enrolled in Regeneron's OPTIMA Trial. We're pleased to announce the trial is full and its status is now "Active, Not Recruiting."

This Phase 3 trial of garetosmab enrolled 63 patients. The data from all patients will be reviewed for safety and efficacy when all patients reach 56 weeks of trial participation. After that review, a decision will be made on whether garetosmab will be submitted to the regulatory agencies (like the FDA and European Medicines Agency, etc) for consideration as a new treatment for FOP.

Earlier this year, Regeneron published a Plain Language Summary of its Phase 2 results of the garetosmab LUMINA-1 Trial. The Summary is available in Chinese, Dutch, French, Italian, Japanese, Polish, Portuguese and Spanish. View the Plain Language Summary