Alcon receives FDA approval for preservative-free travoprost
FORT WORTH, Texas The Food and Drug Administration has approved a formulation of preservative-free travoprost for lowering IOP in patients with open-angle glaucoma or ocular hypertension, Alcon Inc. announced.
The approval is for Travatan Z. Alcon has replaced the benzalkonium chloride (BAK) preservative in the original Travatan formulation with sofzia, an ionic-buffered preservative system that is more gentle on the ocular surface, according to a company press release. Topical solutions containing BAK may exacerbate conditions, such as dry eye, the press release stated.
The approval was based on a double-masked, multi-center study of 690 adult patients with open-angle glaucoma or ocular hypertension. Travatan Z reduced IOP by an average of 8.5 mm Hg, demonstrating statistically equivalent IOP-lowering capacity to the original Travatan, company officials said in the release.