Restylane (Hyaluronic acid) touted as safer and a longer-lasting alternative to collagen.

A non-animal-based wrinkle corrector that has been the talk of the cosmetically savvy for years has finally received regulatory approval. The Food and Drug Administration approved Restylane (hyaluronic acid, Q-Med) for the treatment of moderate to severe facial wrinkles and folds such as nasolabial folds on Dec. 12. Scottsdale, Ariz.-based Medicis will distribute the product in the United States. The product has been in use for years in Europe and Canada, noted oculoplastic surgeon Stephen Bosniak, MD. “All across the United States, the people who are really up on their noninvasive cosmetic procedures have known about Restylane, and they’ve been asking their doctors for at least several years now,”he said. “It’s a great advance. We’ve treated many patients with exquisite results,”said dermatologist Jeffrey S. Dover, MD. “Collagen and Restylane do the same thing, but there’s a reason why I don’t feel that they will be particularly competitive,”Dr. Bosniak said. “And that is because collagen is an animal product, collagen can cause allergies, collagen requires skin testing, and Restylane does none of the above.” Dr. Bosniak, who with colleague Marian Zilkha, MD, published a study of almost 2,200 Brazilian patients injected with Restylane, said that he does not use collagen in his practice. “In countries where Restylane has been available, the use of collagen has decreased markedly,”he said.

Side-by-side comparison: Dr. Dover noted that the formulation of collagen has also improved in the past year. Physicians now have access to human-derived collagen, which was approved by the FDA in March 2003 as an alternative to bovine-derived forms. Human collagen, made from neonatal foreskins, induces fewer allergic reactions than bovine collagen and does not require weeks of waiting for skin test results, Dr. Dover said. He added that it is more expensive than bovine collagen. The clinical FDA trials compared Restylane side by side with Zyplast (bovine collagen, Inamed) in a study of 138 patients with prominent nasolabial folds. Patients were injected with one agent on each side of the face. Masked investigators evaluated patients at 2, 4 and 6 months after patients achieved an “optimal cosmetic result,”according to the study.

The introduction of Restylane to the U.S. market may soon be followed by regulatory approval of another collagen alternative. Inamed, maker of Zyplast, is introducing its own hyaluronic acid-based gel, Hylaform. It was recommended for approval on Nov. 21, the same day as Restylane, but it has not received formal approval from the FDA yet. Hylaform contains avian protein, but a skin test is not required before injection, according to information on the company Web site. Both Restylane and Hylaform are manufactured in three formulations. Only one Restylane formulation is currently approved for use in the United States. Restylane Perlane and HylaformPlus contain the largest gel particles and are intended for deep folds. Both products also have a fine lines formulation, which contains the smallest gel particles and is injected into the superficial dermis.

Excerpt from OCULAR SURGERY NEWS 2/1/04

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