Mentor says that all patients in the Phase 2 study have been enrolled, which should enable the product to be on the market within the next year if test results prove satisifactory.
Following in the path of the ever-popular Botox injections, the treatment aims to temporarily eradicated fine lines and wrinkles, particularly in the area around the eyes and frown-lines on the forehead, through a simple injection process.
Corey Maas, M.D., director of the Maas Clinic and Associate Clinical Professor at the University of California at San Francisco Medical School, and principal investigator of the study, said. "Mentor's Phase 2 dose-finding study is designed to determine the optimal dose level to move forward into a large registration study to establish product safety and efficacy."
The company says that the multi-center dose-finding study includes a six month follow-up period and is based on results from the Phase 1 dose escalation safety study, which was initiated in December 2004.
"Our botulinum toxin program represents a significant opportunity for Mentor and we are pleased with the rapid pace of its advancement through the clinical trial process," commented Joshua Levine, CEO of Mentor Corporation.
"We are building our presence in the area of facial rejuvenation through our dermal filler and botulinum toxin product development programs and expect to have an even broader presence in these markets in the future."
Mentor established its botulinum toxin program through a licensing agreement with the Wisconsin Alumni Research Foundation in December 2003. This agreement gives the company exclusive rights to all strains of the botulinum toxin, including botulinum toxin type A, giving it the right to manufacture, develop and commercialize the underlying technology worldwide.
Back in November 2004, Mentor announced that it had commissioned its state-of-the-art manufacturing facility in Madison, Wisconsin, which is expected to come on-line in conjunction with its plans to product and market botulin toxin type A once testing is completed.
Clinics in Europe are reporting that the number of Botox treatments being carried out are currently doubling each year. In the US, where the treatment is a lot more advanced, it was estimated that nearly three million botox treatments were carried out in 2003 alone.