The US Food and Drug Administration (FDA) has approved bimatoprost 0.01% ophthalmic solution (Lumigan; Allergan) for the first-line treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
As with the previously approved 0.03% formulation, bimatoprost 0.01% solution is administered as 1 drop in the affected eye(s) once daily in the evening.
FDA approval was based on data from a 3-month study showing that bimatoprost 0.01% decreased IOP by up to 7.5 mm Hg from an average baseline of 23.5 mm Hg, a reduction comparable to that associated with the 0.03% solution (8 mm Hg) but with only one-third the drug exposure.
Decreased drug exposure has been linked to improved tolerability and a significant decrease in the incidence of adverse events, including less frequent and severe hyperemia; other adverse effects included eyelash growth and ocular pruritus. The lower-dose formulation was also linked to a significantly decreased discontinuation rate after 1 year (8.1% for bimatoprost 0.01% vs 13.4% for bimatoprost 0.03%).
"The approval of Lumigan 0.01% provides doctors with an efficacious, safe and well-tolerated IOP-lowering medication for glaucoma patients who are either starting treatment or are changing their medication regimen," said Scott Whitcup, MD, Allergan's executive vice president, research and development, and chief scientific officer, in a company news release. "Lumigan 0.01% exemplifies Allergan's commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure."
Treatment with bimatoprost ophthalmic solution has been linked to reports of increased pigmentation in the iris, eyelid, and eyelashes; pigmentation of the eyelid and lashes may be reversible on discontinuation of therapy. Iris color changes, though often permanent, may not be noticeable for several months to years and typically appear as a brown pigmentation around the pupil that spreads toward the periphery of the iris.
Macular edema, including cystoids macular edema, has also been reported during bimatoprost therapy. Caution is advised when treating aphakic patients, pseudophakic patients with a torn posterior lens capsule, and those with known risk factors for macular edema. Patients with active ocular inflammation, such as uveitis, may experience an exacerbation of the condition.