The US Food and Drug Administration (FDA) has approved latanoprost ophthalmic emulsion 0.005% (Xelpros, Sun Pharmaceuticals) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, the company has announced.
Xelpros is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations, the company said.
"As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension," Abhay Gandhi, chief executive officer, North America, Sun Pharma, said in a news release.
In randomized controlled trials of patients with open-angle glaucoma or ocular hypertension and mean baseline IOP of 23 to 26 mm Hg, Xelpros lowered IOP by a mean of up to 6 to 8 mm Hg.
The most common ocular adverse reactions were eye pain/stinging on instillation, and ocular hyperemia, reported in 55% and 41% of patients, respectively. Fewer than 1% of patients stopped treatment because of intolerance to these adverse events.
Xelpros is indicated for first-line treatment of open-angle glaucoma or ocular hypertension. The recommended dose is one drop in the affected eye or eyes once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of IOP starts about 3 to 4 hours after administration, and the maximum effect is reached after 8 to 12 hours.
Xelpros is contraindicated in patients with known hypersensitivity to latanoprost or any other ingredients in this product. Full prescribing information is available on the Xelpros web site.
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Cite this: FDA Clears New Form of Latanoprost (Xelpros) for Glaucoma - Medscape - Sep 19, 2018.