Study Overview:

If you are eligible and choose to participate in the Dystance study, you will have the opportunity to participate in two study periods: The Double-Blind Period and the Open-Label Period.

The Double-Blind Period will include a treatment day and at least a 12-week follow-up period. You will be randomly assigned (like the flip of a coin) to receive either one of 2 doses of study medication or placebo, which has no active ingerdients. On treatment day, you will receive injections of study medication or placebo into the muscles of your foot with the bunion. If both feet have a bunion, you will receive study medication or placebo in the foot that is more severe during this period.

If you qualify for re-treatment, you wil be treated during the Open-Label Period, which can last up to 24 weeks. All participants in this period may receive up to 2 injections of study medication with the active ingredient.

The study team will monitor your health and discuss assessments with you throughout the study.