Thea Pharma announced FDA approval of Iyuzeh (latanoprost ophthalmic solution) 0.005% for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Iyuzeh is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free, according to Thea.

Iyuzeh is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK). Iyuzeh has demonstrated consistent IOP-lowering effects and proven tolerability across multiple trials in the US and Europe. In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with mean baseline IOP of 19-24 mmHg, Iyuzeh lowered IOP by 3-8 mmHg versus 4-8 mmHg by Xalatan (latanoprost ophthalmic solution) 0.005%, which is preserved with BAK.

“The approval of Iyuzeh is a significant milestone for Théa Group, as this is our first FDA approval for a prescription ophthalmic medicine, for our U.S. subsidiary,” Jean-Frédéric Chibret, President of the Théa Group, said in a company news release. “Marketed outside of the U.S. as Monoprost, the market leading prostaglandin analogue (PGA) in volume, is available in over 46 countries around the world, including France, Germany, Spain, United Kingdom, Italy, and Canada. We are extremely proud to bring our unique preservative-free latanoprost eye drop, Iyuzeh to the U.S."

“Our novel patent protected formulation has been made possible by Théa’s innovative 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 PGA products," Susan Benton, Thea’s U.S. President, said in the news release. "Additionally, Théa is responding to an important unmet need across all stakeholders in the treatment of OAG and OHT. Many patients on preserved glaucoma medications experience moderate to severe signs and symptoms of ocular surface disease (OSD) that can cause discomfort for patients, frustration for physicians, and drive additional costs for payers. We look forward to introducing Iyuzeh to U.S. eyecare practitioners in the second half of 2023."