By Rod Franklin
The most recent phase 2 studies on a topically delivered botulinum toxin type A lend clinical support to an investigational product that physicians might use one day to essentially wipe away crow’s feet wrinkles around the eyes, according to a consultant for the developer.
Addressing members at the ASPS annual meeting, Michael Kane, MD, a plastic surgeon in private practice in New York City, emphasized the exacting efficacy standards that were observed in two randomized trials that tested a gel known as RT001, which employs a novel macromolecule delivery system to relax muscles in the sensitive periorbital area.
"We’re actually getting a very large payload to go through cell membranes and skin cells, allowing for penetration down to the muscle," the New York surgeon reports. "Throughout phase 2 we’ve had 11 clinical trials, and over 550 patients have been treated with the drug. We’ve had no treatment-related serious adverse events, and we’ve had a 115-day duration of effect."
RT001, under development by California-based Revance Therapeutics, was well tolerated in a double-blind placebo-controlled study of 90 patients and in a study of 180 patients that compared the compound’s individual components. The product is now scheduled for its end-of-phase 2 review.
In the botulinum toxin type A gel is a peptide carrier that penetrates skin to relax the orbicularis oculi muscle. Although it can be topically applied, RT001 won’t be sold over the counter; it requires the assistance of a physician. If approved, it will be marketed as a painless alternative for people who would otherwise be treated with injectable botulinum toxin A (Botox).
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