Bimatoprost gets nod for hypotrichosis

January 15, 2009

Allergan has received FDA approval for its 0.03% bimatoprost ophthalmic solution (Latisse) as a novel treatment for hypotrichosis of the eyelashes.

Key Points

Irvine, CA-Allergan has received FDA approval for its 0.03% bimatoprost ophthalmic solution (Latisse) as a novel treatment for hypotrichosis of the eyelashes. The company markets the prostaglandin analog under a different name (Lumigan) for the treatment of glaucoma and ocular hypertension; it was approved for this use in 2001, and it was noted that patients who used it experienced eyelash growth as a side effect.

"[The new product] fulfills a significant and previously unmet need in the medical aesthetic marketplace with a product approved by the FDA that increases the growth of eyelashes, making them longer, thicker, and darker," said Scott Whitcup, MD, Allergan's executive vice president of research and development.

To treat hypotrichosis, a patient applies the prescription to the base of the upper eyelashes once a day using a sterile, single-use, disposable applicator. The treatment takes effect in as few as 8 weeks, according to the company. To maintain the effect, patients must continue using the drug. If use is discontinued, eyelashes gradually will return to their prior length.

"I observed statistically significant differences in eyelash growth and resulting patient satisfaction," said clinical investigator Steven Fagien, MD, FACS, an oculoplastic surgeon in private practice at Aesthetic Eyelid Plastic Surgery in Boca Raton, FL. "Now that [the product] is FDA-approved, I look forward to prescribing it to my patients who will enjoy the benefits of more prominent eyelashes while I remain confident in the treatment's favorable safety profile."

Allergan indicated that it expects to launch bimatoprost as a hypotrichosis treatment nationwide in the first quarter of this year. It will be available by prescription only. The company estimates that global peak sales of the product could exceed $500 million per year. As the exclusive U.S. and foreign patent owner, Allergan obtains the rights to the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate eyelash growth.

Further product and prescribing information is available at http://www.latisse.com/.