Mentor Corporation Announces FDA Approval of Prevelle Silk: First Dermal Filler to Prove Pain Reduction in the U.S.
Mentor Corporation (NYSE: MNT), a leading supplier of medical products
for the global aesthetic market, today announced that the Food and Drug
Administration (FDA) has approved Prevelle Silk. This is the first of a
new line of lidocaine containing hyaluronic acid (HA) dermal fillers
that Mentor anticipates marketing and distributing globally.
Prevelle Silk is a colorless HA gel with lidocaine that is injected into
facial skin to reduce moderate to severe facial lines, folds, and
wrinkles. The product is the first in a new line of HA dermal fillers
that Mentor is developing with Genzyme Corporation (NASDAQ: GENZ).
Lidocaine, a local anesthetic, is added to provide pain relief at the
site of the injection. In a controlled clinical study, patients
experienced significantly less pain during injection with Prevelle Silk
when compared to an HA product that did not contain lidocaine.
Mentor Corporation has forged a strategic development partnership with
Genzyme Corporation, a global leader in the development and
manufacturing of HA products. Mentor Corporation will market and
distribute the products globally.
"We believe both patients and physicians will be excited to have an
effective dermal filler option with lidocaine to help make the filler
injection more comfortable," said Brian Luedtke, Vice President of
Global Marketing and Sales of Mentor Corporation. "We
believe Prevelle Silk will be an excellent complement to our portfolio
of lidocaine containing HA dermal fillers, the second of which is under
review with FDA and the third in clinical trial. We will shortly begin
targeted launch efforts to experienced dermatology and plastic surgery
dermal filler customers and anticipate a broader U.S. commercial launch
in combination with our second dermal filler later this year."
About Prevelle Silk
PREVELLE SILK is indicated for injection into the mid to deep dermis for
correction of moderate to severe facial wrinkles and folds (such as
nasolabial folds). In clinical studies, adverse events were usually mild
to moderate in nature, did not require intervention and lasted seven
days or less. The most common side effects included temporary injection
site reactions such as swelling, pain/tenderness, redness, and
lumps/bumps.
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
This release contains forward-looking statements including, but not
limited to, statements relating to Mentor’s
strategic partnership with Genzyme. A number of factors could cause
actual results to differ from the forward-looking statements including,
but not limited to, consumer use of the products offered by Mentor and
Genzyme. Other important risk factors are described in the Company’s
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, recent
Current Reports on Form 8-K and other Securities and Exchange Commission
filings. These important risk factors could affect the Company’s
business, results of operations and financial condition. The Company
undertakes no obligation to revise or update publicly any
forward-looking statement for any reason.
