FDA advisory committee recommends approval of LATISSE as a treatment for hypotrichosis of eyelashes

Dec 8 2008

Allergan, Inc. has announced the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (9-0) to recommend that the FDA approve LATISSE (bimatoprost solution 0.03%) as a treatment for hypotrichosis (or reduced amount of hair) of the eyelashes.

If approved, LATISSE would be the first and only FDA-approved pharmaceutical to enhance eyelash prominence.

"Today's Advisory Committee recommendation is an important step in the FDA review process to provide consumers with a safe and effective treatment to improve the length, thickness and darkness of natural eyelashes," said Scott Whitcup M.D., Allergan's Executive Vice President of Research and Development. "Recently, unapproved eyelash products containing active drug ingredients have appeared on the market. If approved, LATISSE will offer consumers an FDA-approved product which has been extensively studied in well-controlled clinical trials, is manufactured to pharmaceutical standards, is appropriately labeled for use, and is regulated as a prescription product."

In addition to its unanimous recommendation for approval of LATISSE, the Committee also voted 5-3 (1 abstained vote) in favor of Phase 4 (post-market studies) to assess use in certain patient populations, including patients of younger age and post-chemotherapy patients with loss of eyelashes.

The Committee's recommendation, although not binding, will be considered by the FDA as it contemplates approval for LATISSE as a treatment for eyelash growth. If approved by the FDA, Allergan anticipates launching LATISSE in 2009.