The FDA has approved Alcon Laboratories' travoprost ophthalmic solution 0.004% formulated with a proprietary ionic-buffered preservative system for first-line treatment to reduce elevated IOP in patients with ocular hypertension or open-angle glaucoma.
Fort Worth, TX-The FDA has approved Alcon Laboratories' travoprost ophthalmic solution 0.004% (Travatan Z) formulated with a proprietary ionic-buffered preservative system (sofZia) for first-line treatment to reduce elevated IOP in patients with ocular hypertension or open-angle glaucoma.
"As a class, prostaglandin analogues [PGAs] have become the first line for IOP-lowering therapy because of their efficacy and systemic safety," said Ronald L. Gross, MD, holder of the Clifton R. McMichael Chair in Ophthalmology and professor of ophthalmology, Cullen Eye Institute, Baylor College of Medicine, Houston.
"Available clinical trial data demonstrate the ocular hypotensive activity of travoprost preserved with [the ionic-buffered preservative system]. As an option that eliminates exposure to benzalkonium chloride [BAK], this PGA formulation is a particularly good choice for patients with existing ocular surface disease as well as for those at high risk for developing such problems," he added.
A recent clinical study compared the efficacy and safety of once-daily treatment with travoprost 0.004% with BAK with that of the formulation with the ionic-buffered preservative system, whereas another study compared the duration of IOP reduction with the BAK-free formulation of travoprost and the original preparation.
"Breakdown in the integrity of the ocular surface with the use of a topical medication containing BAK might be expected to allow increased intraocular penetration of the active agent with the potential for increased IOP-lowering activity," Dr. Gross said. "However, IOP measurements obtained in these clinical studies demonstrate there is no loss of efficacy when the preservative for travoprost is changed from BAK to [the novel preservative system] whether patients are followed for 24 hours postdosing or for up to 60 hours.
"The safety data in these studies also support a benefit for eliminating BAK," he concluded. "Although there was no statistically significant difference in the incidence of hyperemia between groups of patients using travoprost with [the novel preservative system] versus with BAK, removal or avoidance of BAK was associated with a substantial reduction in hyperemia."