Bimatoprost gets nod as hypotrichosis treatment

January 6, 2009

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

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.

The safety and efficacy of bimatoprost was clinically tested for use as a treatment for hypotrichosis in a pivotal phase III, multicenter, double-masked, placebo-controlled study in which 278 healthy adult patients with no active ocular disease and with baseline minimal or moderate eyelash prominence were randomly assigned to apply either bimatoprost or vehicle to both upper eyelid margins once daily for 16 weeks. All endpoints-improved eyelash prominence, length, thickness, and darkness-were met, according to the company. The most commonly reported adverse events were eye redness (3.6%), itchy eyes (3.6%), and skin hyperpigmentation (2.9%).

“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

www.latisse.com

.