The US Food and Drug Administration (FDA) has approved Allergan Inc. product Botox (botulinum toxin type A) to improve the appearance of moderate to severe glabellar lines, or furrows between the eyebrows. The approval applies to men and women 65 or younger.
The FDA approved Botox in 1989 for the treatment of crossed eyes and uncontrollable blinking. In December 2000, the drug won US approval for treating abnormal head position and neck pain associated with cervical dystonia.
Botox, administered by injection, improves the appearance of brow furrow lines by blocking the nerve impulses that lead to contraction of the major muscles in the forehead. Treatment is usually repeated at least every four months to preserve the effect.
FDA approval was based on a 12-month repeated-treatment trial of 537 patients and eight months of open-label follow-up of 373 of those subjects. Maximum response rate was achieved at day 30, with about 80% of Botox-group subjects identified by investigators as responders, compared with 3% of the placebo group.
The preoperative use of Botox to reduce adverse effects of blepharoplasty requires more support – very little literature is available and most of it reports personal surgical experience.
Fagien, Steven M.D. Temporal Brow Lift Using Botulinum Toxin A. Plastic & Reconstructive Surgery. 112(5) Supplement:105S-107S, October 2003.