Botox Competitor Once Step Closer

Mentor Corporation announced completion of the first of three Phase 3 clinical trials with its purified botulinum Type A neurotoxin (PurTox(R)) for the reduction of glabellar rhytides (frown lines). This newly completed study involved 400 subjects at ten investigational sites in the United States. Subjects received a single treatment with PurTox or placebo.

Using a validated 4-point photo scale as a reference, reduction in line severity was scored by subjects, investigators, and independent reviewers at time points through six months. Satisfaction with treatment outcome was measured using a standard global satisfaction assessment tool and safety was assessed by adverse event tracking. The results for the primary efficacy endpoint and for each of the eight secondary efficacy endpoints were all highly significant (p less than or equal to 0.0001 in each case). For each of these endpoints, the findings were indicative of a substantial treatment effect. In addition, a very large percentage of subjects expressed a high degree of satisfaction with the treatment outcome.

Data from the three Phase 3 studies will be used to support the filing of a BLA (Biologics License Application) with the U.S. Food and Drug Administration. The remaining two Phase 3 studies for this indication have completed enrollment and are currently in the follow-up stage.

source: http://ir.mentorcorp.com/phoenix.zhtml?c=76343&p=irol-newsArticle&ID=1204308&highlight=