Disfiguring
scarring in the skin is an area of high medical need. Current treatments for
scarring have variable or limited effectiveness and have typically not been evaluated in randomized, controlled, double-blind clinical trials. The prophylactic improvement in
scar appearance, through administration of agents around the time of injury, represents a new therapeutic approach for which there are currently no registered
pharmaceuticals. Extensive research into the mechanisms of
scar-free and
scar-forming healing has provided a robust scientific rationale for the development of
avotermin (human recombinant
TGF-beta3) as a potential therapeutic for the improvement of
scar appearance in humans. The pioneering approach used for the clinical development of
avotermin in this new indication has explained the efficacy and safety profile of
avotermin in several, prospectively randomized, double-blind clinical studies in human volunteers and patients. These studies, which show a clear translation from preclinical efficacy models to the clinical environment, have shown that prophylactic
scar improvement is pharmaceutically achievable. It is anticipated that
therapeutics such as
avotermin, with a sound mechanistic basis and proof of effectiveness in suitably robust clinical trials, will be available to meet the needs of patients in the foreseeable future.