Reduction Of Frown Lines - Mentor Corporation Announces Completion Of PurTox(R) 3A Study

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 03 Oct 2008 - 1:00 PDT

email to a friend   printer friendly   opinions  

Mentor Corporation (NYSE:MNT), a leading supplier of medical products for the global aesthetic market, today announced completion of the first of three Phase 3 clinical trials with its purified botulinum Type A neurotoxin (PurTox®) 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 ≤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.

About Mentor Corporation

Mentor is a leading supplier of medical products for the global aesthetic market. The Company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to retain a more youthful appearance and improve their quality of life. The Company's website is http://www.mentorcorp.com.

Safe Harbor Statement

All statements included or incorporated by reference in this release, including statements regarding the clinical studies for our botulinum toxin Type A neurotoxin product candidate, but excluding statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us. These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors.

The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Report on Form 10-K, subsequent quarterly report on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition. Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason.

Mentor Corporation

• Additional
• References
• Citations