Alcon, Inc. has announced that the US Food and Drug Administration (FDA) has approved Travatan Z (travoprost ophthalmic solution) 0.004 per cent for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications. Travatan Z is a new formulation that eliminates benzalkonium chloride (BAK) from Alcon's existing Travatan solution and replaces BAK with Sofzia, a robust ionic-buffered preservative system that is gentle to the ocular surface. Alcon developed this BAK-free version of Travatan because long-term use of topical solutions containing BAK may compromise the ocular surface and exacerbate conditions such as dry eye.

"Because almost 40 per cent of glaucoma patients suffer from Ocular Surface Disease, Travatan Z is an advance in therapy which we believe will now enable doctors to address an unmet need of many glaucoma patients," said Kevin Buehler, Alcon's senior vice president, United States and chief marketing officer.

FDA approval of Travatan Z solution was based on a double-masked, multi-centre study, which has been accepted for publication by the Journal of Glaucoma. The 690 adult patients with open-angle glaucoma or ocular hypertension were randomised to receive Travatan or Travatan Z. Travatan Z reduced IOP up to 8.5 mmHg on average demonstrating statistically equivalent IOP lowering efficacy to the original Travatan. Similar adverse events were noted in both groups.

"These data demonstrate that Travatan Z is equally effective in reducing intraocular pressure in glaucoma patients compared to Travatan(R) with BAK," said Rick Lewis, MD, Grutzmacher and Lewis, Inc., Sacramento, CA, and lead investigator of this study. "However, chronic use of Travatan Z is less likely to compromise the ocular surface, potentially reducing eye irritation in glaucoma patients also suffering from ocular sensitivities."