Generic Name: travoprost ophthalmic solution 0.004%
Date of Approval: September 21, 2006
Company: Alcon, Inc.
Treatment for: Glaucoma and Ocular Hypertension
The U.S. Food and Drug Administration (FDA) has approved Travatan Z (travoprost ophthalmic solution) 0.004% 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(TM), 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 percent 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-center study which has been accepted for publication by the Journal of Glaucoma. The 690 adult patients with open-angle glaucoma or ocular hypertension were randomized 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 with BAK," said Rick Lewis, M.D., Grutzmacher & 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."
About Travatan and Travatan Z Solutions
Travatan and Travatan Z are both indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive to another IOP lowering medication. These therapies are contraindicated in patients with hypersensitivity to travoprost or any other ingredient in these products.
Glaucoma, a group of diseases that can damage the eye's optic nerve, is the second leading cause of blindness worldwide. The onset of glaucoma often occurs with no symptoms, but if it remains untreated, gradual loss of peripheral vision may ensue. When diagnosed early, glaucoma can be treated with medicines, laser trabeculoplasty, conventional surgery, or a combination of therapeutic options. While remaining vision may be preserved through treatment, there is currently no cure for glaucoma and lost vision cannot be restored.
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- Drug class: ophthalmic glaucoma agents