SANTA BARBARA, Calif.--(BUSINESS WIRE)--
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(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.
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
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.
Source: Mentor Corporation