Bimatoprost 0.03% solution rreceives approval as first-line treatment

Irvine, CA-The FDA's new indication of bimatoprost ophthalmic solution 0.03% (Lumigan, Allergan) from a second- to a first-line treatment for elevated IOP expands the options to ophthalmologists who commonly treat open-angle glaucoma or ocular hypertension.

Ronald L. Gross, MD, professor of ophthalmology and Clifton R. McMichael Chair of Ophthalmology at the Cullen Eye Institute, Baylor College of Medicine, Houston, prefers to use prostaglandin analogs-latanoprost 0.005% (Xalatan, Pfizer), travoprost 0.004% (Travatan, Alcon Laboratories), or bimatoprost 0.03%-as a first-line treatment to timolol or the combination drug, dorzolomide hydrochloride-timolol maleate (Cosopt, Merck).

Dr. Gross said glaucoma specialists have previously used bimatoprost off-label as a first-line treatment if they believed it was warranted by their patients' needs.

Scott Whitcup, MD, Allergan's executive vice president, research and development, said approval of the new indication is an important step.

"The FDA approval of a first-line indication is significant because it affirms the long-term safety and efficacy of the medication," Dr. Whitcup said. "This first-line indication for [bimatoprost] supports the use of the medication to lower IOP at any point in the course of glaucoma or ocular hypertension."

The drops are used once daily and have been shown to help patients achieve target pressures of 18 mm Hg or lower, he said.

"Effective, once-daily medications are especially useful for chronic diseases like glaucoma, where long-term compliance is important," Dr. Whitcup said.

According to the label, bimatoprost 0.03% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Although the FDA approval indicates the drug is safe and effective, some patients who use the drug might notice an increase in the brown pigmentation of their eyes. Iris pigmentation was reported in seven of 474 patients receiving bimatoprost every day as part of a multicenter, double-masked, randomized, parallel extension of the two pivotal trials, Dr. Whitcup explained.

However, none of the patients discontinued treatment because of that pigmentation change, he noted.

"Importantly, significant IOP reduction was maintained throughout the 4 years of the study," he said.

Dr. Gross said the iris pigmentation change, although permanent, "is purely a cosmetic effect."

However, he advises patients to take care when administering the drops to avoid getting it on the skin around their eyes, because it can temporarily darken as well. He recommends patients apply face cream to act as a skin barrier before instilling the drops, and immediately wash their face afterward. If the skin does darken, it will return to normal pigmentation once the drops are discontinued, he noted. Eyelash growth is also a side effect of bimatoprost, Dr. Gross said, but that is considered "a positive" by most patients.

The FDA approved bimatoprost 0.03% in 2001 as a second-line treatment. With the June 23 approval, the lipid-class drug joins brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) in Allergan's portfolio of first-line IOP-lowering treatments.