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6/2/2001

Two New Ophthalmic Solutions Enter Glaucoma Market

Tzipora R. Lieder

In March, FDA approved the marketing of two new ophthalmic solutions for the reduction of elevated intraocular pressure (IOP). Bimatoprost (Lumigan [PDF], Allergan) and travoprost (Travatan [PDF], Alcon) are synthetic prostaglandin analogues that lower IOP by increasing the outflow of aqueous humor. They are indicated for use in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering medications or do not respond sufficiently to them.

In the clinical studies of 0.03% bimatoprost ophthalmic solution, patients with open-angle glaucoma or ocular hypertension whose mean baseline IOP was 26 mm Hg were treated once daily in the evening. Their IOP decreased by 7–8 mm Hg.

In studies of 0.004% travoprost ophthalmic solution, patients with open-angle glaucoma or ocular hypertension and a baseline IOP of 25–27 mm Hg who administered the drug once daily also had an IOP reduction of 7–8 mm Hg. Subgroup analysis showed that the drug produced a reduction up to 1.8 mm Hg greater in black patients than in other patients. In another study, the addition of travoprost to twice-daily timolol therapy lowered patients’ IOP by 6–7 mm Hg, from an initial 24–26 mm Hg.

Treatment with bimatoprost or travoprost has been reported to increase iris, eyelid, and eyelash pigmentation and eyelash length, thickness, and number. These changes may be permanent. The most common adverse effect is conjunctival hyperemia. Other local effects include visual disturbance, foreign-body sensation, blepharitis, and eye discomfort, pain, pruritus, and dryness.

Travoprost, a prostaglandin FP-receptor agonist, should not be used during pregnancy or by women attempting to become pregnant. Because prostaglandin analogues have been linked to cases of macular edema, bimatoprost and travoprost should be used with caution in patients at risk for this condition.

Both ophthalmic solutions contain benzalkonium chloride, which may be adsorbed to soft contact lenses. Patients should remove contact lenses before instilling the ophthalmic solution and may reinsert the lenses 15 minutes after administration.

The recommended dosage of 0.03% bimatoprost ophthalmic solution and 0.004% travoprost ophthalmic solution is one drop in the affected eye or eyes once daily in the evening. Bimatoprost solution is supplied in 2.5-, 5-, and 7.5-mL volumes in 8-mL bottles. Travoprost is supplied as 2.5 mL of solution.