FDA Approves Benzalkonium Chloride-Free Glaucoma Solution

The US Food and Drug Administration (FDA) has approved latanoprost ophthalmic emulsion solution (XELPROS) .005% as the first and only benzalkonium chloride-free (BAK-free) form of latanoprost.

The therapy, from Sun Pharmaceutical Industries, received New Drug Application (NDA) approval and indication for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The NDA was approved based on the results of randomized, controlled clinical trials involving patients with open-angle glaucoma or ocular hypertension, and mean baseline IOP of 23-26 mmHg.

The translucent ophthalmic emulsion lowered patient IOP by a mean 6-8 mmHg from baseline, according to Sun Pharmaceuticals. The most frequently reported adverse reactions to patient eyes across multiple trials were pain/stinging upon administration, and ocular hyperemia (redness). Both events were reported in 55% and 41% of patients administered the solution, respectively. As a result, less than 1% of patients discontinued therapy due to intolerance.

As a prostaglandin analogue that serves as a first-line treatment for its indicated conditions, XELPROS is recommended at doses of 1 drop in each infected eye once daily in the evening. Reduction of IOP is intended to begin 3-4 hours following administration, with maximum effect being observed 8-12 hours following.

Anil Raghavan, chief executive officer of Sun Pharma Advanced Research Company (SPARC), called the approved a significant milestone for the company—one that validates its Swollen Micelle Microemulsion technology used to solubilize drugs in lieu of BAK.

Abhay Gandhi, chief executive officer of North America Sun Pharma, echoed those sentiments for the company’s technology, as well as its Ophthalmics division.

“As the only BAK-free version of latanoprost, XELPROS^TM will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” Gandhi said in a statement.