Pivotal trial data inclusion in Medicis/Q-Med's Restylane labeling will be sufficient to demonstrate superiority over Inamed's Zyplast , should it earn FDA approval, according to Medicis.

In a Nov. 21 teleconference to discuss the outcome of FDA's same-day panel review of Restylane, Medicis CEO Jonah Shacknai deflected comparisons with another Inamed wrinkle treatment, Hylaform .

Co-developed with Genzyme, Hylaform was considered by the panel on the same day as Restylane. Commenting on the two hyaluronic acid-based dermal fillers, Shacknai said: "It is not our purpose to compete against products that we believe to be of lesser value in a patient context."

Regarding a potential head-to-head trial comparing Restylane with Hylaform, the exec added: "It would be like a study between some delicious fresh-squeezed orange juice and a concentrate that's been in the freezer a long time."

Shacknai's bullish demeanor may be partly justified by the extent of the conditions levied on Inamed/Genzyme by the General & Plastic Surgery Devices Panel.

Although both Restylane and Hylaform cleared the panel - in separate votes - by a 6-3 margin, the panel said allergy tests should be required before Hylaform use, and that safety and effectiveness could be proven only for one injection (¹ Also see "Gen/Surg Panel Okays Dermal Fillers 6-3; Minority Patient Studies Proposed" - Medtech Insight, 24 November, 2003., p. 6).

For its part, Medicis also faced a number of panel conditions, including the recommendation that "superiority" over Zyplast be stricken from the proposed labeling.

During the panel review, while some members avowed that Restylane is virtually superior, they acknowledged the data did not demonstrate "statistically significant" superiority over the collagen control.

John Halsey, PhD, president and clinical laboratory director of IBT Reference Lab/ProGene Biomedical, argued that because Restylane is "at least as effective at Zyplast," but produces less adverse events, it is better.

FDA's statistical summary of the clinical trial notes that on the Wrinkle Severity Rating Scale, where a rank of 1 means "no visible fold" and 5 is "extreme," for each patient in whom Restylane was better than the control, the difference was at least one point.

Nevertheless, "although patients treated with Restylane show lower mean values in the SRS scale for all follow-up time points post-treatment, the mean difference between Restylane and Zyplast was always less than 1 point, the minimal clinically significant difference," FDA states.

"The mean difference was less than one point because for 42.9% of the patients, Zyplast was equivalent or better than Restylane," the document explains.

Panelists also addressed Hylaform's non-inferiority to Zyplast, although unlike Medicis/Q-Med, Inamed/Genzyme did not pursue a "superior" indication.

Some members questioned the adequacy of Hylaform's clinical trial data (see ² Also see "Facial Implant Panel Endorsement Masks Study Bias Concerns" - Medtech Insight, 1 December, 2003.). Joseph Boykin, MD, Medical Director of the Wound Healing Center at the Medical College of Virginia, posited: "It certainly isn't superior... Perhaps only half of the [proposed] indications have been met."

By contrast, panelist Michael Olding, MD, chief of plastic surgery at George Washington University School of Medicine, concluded: "Having used the products, there is no doubt as to the efficacy."

Hylaform and Restylane share three panel conditions, including a Phase IV study of treatment of skin of color, physician education and labeling warning the product has not been tested on skin of color.

"We are very easily able to meet the conditions that the panel has requested," Shacknai commented. "In fact, we proposed most of them; they're the things that we're doing anyway."

In September, Medicis announced an increase of 30-40 sales reps, dedicated exclusively to Restylane training and marketing (³ Also see "Medicis Lab-Derived Dermal Filler On Track For Year-End Approval – Exec" - Medtech Insight, 8 September, 2003., p. 19). In addition, the firm has hired an 80-90 surgeon training base, comprised of the "top injecting physicians in the country," according to Shacknai.

Restylane Benefit Over Collagen Will Show In Data, Not Labeling Terms – CEO

More from Archive

More from Medtech Insight