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U.S. Department of Health and Human Services

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Summary from the General and Plastic Surgery Devices Panel Meeting - November 21, 2003

The General and Plastic Surgery Devices Panel met on November 21, 2003 at the Holiday Inn located at 2 Montgomery Village Avenue in Gaithersburg, Maryland. The panel met in order to provide advice and recommendations to the Agency for two premarket approval applications for injectable wrinkle filler materials, Q-Med AB’s Restylane and Genzyme Corporation’s Hylaform.

The meeting began with introductory remarks by CDR Stephen P. Rhodes (Branch Chief, Plastic and Reconstructive Surgery Devices Branch) updating the panel regarding matters since the last panel meeting. In the morning, Q-Med AB presented a summary of their PMA and FDA presented their review of the data in the PMA application for Restylane. The presentations highlighted the results obtained from preclinical and clinical studies performed by the sponsor. The clinical data presented summarized two studies; the pivotal study, which was a randomized, evaluator-blinded, multicenter study in the U.S. comparing the safety and effectiveness of Restylane to a commercially available collagen device. The second study was a non-randomized, open label Swedish study of Restylane for the treatment of depressed cutaneous scars, wrinkles and folds.

With respect to the clinical trial data, both the sponsor and the FDA focused their presentations on the pivotal clinical U.S. study where patients were injected with Restylane into the nasolabial fold on one side of the face and with the collagen filler material into the nasolabial fold on the other side of the face. Effectiveness was assessed by a comparison of the outcome score on each side of the face at 6 months following treatment. Safety was assessed by a comparison of adverse events. The study enrolled 138 patients undergoing cosmetic treatment of the nasolabial folds of the face.

The panel discussed the FDA questions and the data presented by the sponsor and the FDA. Following the discussion, the panel voted for “approval with conditions” by a 6 to 3 vote. Among the conditions of approval were that Q-Med would conduct a post approval study to determine if Restylane was safe for use in persons of color. Among the additional conditions, Q-Med AB was directed to develop a physician education plan that would assure that any potential users would be knowledgeable in the proper injection techniques.

In the afternoon, Genzyme Corporation presented a summary of their PMA and FDA presented their review of the data in the PMA application for Hylaform. The presentations highlighted the results obtained from preclinical and clinical studies performed by the sponsor. The clinical data presented summarized Genzyme Corporation’s pivotal study, which was a randomized, double-blind, multicenter study in the U.S. comparing the safety and effectiveness of Hylaform to a commercially available collagen device at 12 weeks after final injections.

With respect to the clinical trial data, both the sponsor and the FDA focused their presentations on the pivotal clinical U.S. study where both nasolabial folds of the subjects were injected with Hylaform or with the collagen filler material. Effectiveness was assessed by a comparison of the outcome scores for the patients receiving each treatment. Safety was assessed by a comparison of adverse events. The study randomized and treated 261 patients undergoing cosmetic treatment of the nasolabial folds of the face.

The panel discussed the FDA questions and the data presented by the sponsor and the FDA. Following the discussion, the panel voted on its recommendation to the agency. A motion for “not approvable” was defeated 5 to 4. Subsequently, the PMA was recommended for “approval with conditions” by a 6 to 3 vote. Among the conditions of approval were that Genzyme Corporation would conduct a post approval study to determine if Hylaform was safe for use in persons of color. Among the additional conditions, Genzyme Corporation was directed to develop a physician education plan that would assure that any potential users would be knowledgeable in the proper injection techniques.

Contact: David Krause, Ph.D., Executive Secretary,
301-594-3090, x141


Transcripts may be purchased from: (written requests only)
Neal R. Gross & Company
1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005
(202) 234-4433 (voice), (202) 387-7330 (fax)
or
The Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
301-827-6500 (voice) or 301-443-1726 (FAX)

CDRH Advisory Committee Database