FDA approval: Thea’s preservative-free latanoprost for IOP reduction in OAG, ocular hypertension

Thea Pharma announces U.S. Food and Drug Administration (FDA) approval for the New Drug Application of latanoprost ophthalmic solution 0.005% (IYUZEH) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The agent is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free, according to the company.

The drug is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK).

In addition, it has demonstrated consistent IOP-lowering effects and proven tolerability across multiple trials in the U.S. and Europe. In randomized, controlled clinical trials of patients with OAG or OHT with mean baseline IOP of 19-24 mmHg, the drug lowered IOP by 3 – 8 mm Hg versus 4 – 8 mm Hg 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,” said Jean-Frédéric Chibret, president of the Théa Group.

“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,” said Susan Benton, Thea’s U.S. President. “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. 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.”

The company anticipates introducing latanoprost ophthalmic solution 0.005% to U.S. eyecare practitioners in the second half of 2023.