Thea Pharma’s work to eliminate preservatives from latanoprost formulations has landed it an FDA nod in open-angle glaucoma and ocular hypertension, clearing the company to launch a differentiated rival to the incumbent eye drops.
Multiple companies already sell latanoprost eye drops in the U.S. to lower elevated intraocular pressure, with Sun Pharmaceutical Industries’ Xelpros and Viatris’ Xalatan among the branded options available to patients. However, the existing options contain preservatives such as benzalkonium chloride that studies have shown to be potentially damaging to the eye surface.
Thea Pharma, the U.S. subsidiary of France’s Laboratoires Théa, is now poised to introduce a rival form of latanoprost, branded Iyuzeh, that may offer advantages over the existing products. The FDA approved the formulation, which has been sold in Europe as Monoprost since 2013, after seeing data from clinical trials, including results showing how Iyuzeh fared against Xalatan.
In randomized, controlled clinical trials of patients with open-angle glaucoma and ocular hypertension, Iyuzeh lowered intraocular pressure by 3 mmHg to 8 mmHg compared to 4 mmHg to 8 mmHg for Xalatan. Susan Benton, Thea’s U.S. president, attributed the ability of the eye drops to lower pressure without the use of preservatives to the work of Thea’s scientists.
“They were able to solve the challenges of solubilizing and stabilizing latanoprost such that Iyuzeh does not need to be manufactured, distributed, or stored at refrigerated temperatures unlike some other competitive brand and generic latanoprost and [prostaglandin analogue] products,” Benton said in a statement.
Thea claims Monoprost is the leading prostaglandin analogue by volume. With the FDA approval, Thea is now gearing up to launch Iyuzeh in the second half of next year and find out the product can make a dent on the U.S. market.