Thea receives FDA approval for preservative-free latanoprost for IOP reduction

The FDA has approved latanoprost ophthalmic solution 0.005% (IYUZEH, Thea Pharma Inc.) for decreasing elevated intraocular pressure in open-angle glaucoma and ocular hypertension.

The agent is the first and only clinically proven preservative-free drop formulation of latanoprost currently available in the US, according to the company.

The FDA approval was based on the formulation’s consistent IOP-lowering effects and proven tolerability across multiple trials in the US and Europe. In randomized, controlled clinical trials of patients with OAG or OHT who had mean baseline IOPs ranging from 19 to 24 mmHg, IYUZEH resulted in IOP decreases of 3 to 8 mmHg compared with 4 to 8 mmHg by XALATAN(latanoprost ophthalmic solution, Pfizer) 0.005%, whichcontains the preservative benzalkonium chloride.

The IOP-lowering effect of the drug lasts 24 hours with 1 drop instilled at bedtime. The effect begins 3 to 4 hours after instillation and peaks at 8 to 12 hours after instillation. Minimal side effects of conjunctival hyperemia (34%) and eye irritation were reported.

According to a company press release, the drug is supported by a strong global legacy.

Jean-Frédéric Chibret, President of the Théa Group, commented, “Marketed outside of the U.S. as Monoprost, the market’s leading prostaglandin analogue 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 US.”

This is our first FDA approval for a prescription ophthalmic medicine, for Théa Group’s US subsidiary.

Susan Benton, Thea’s US President, explained that this formulation solves the challenges of solubilizing and stabilizing latanoprost, in that IYUZEH does not require manufacturing, distribution, or storage at refrigerated temperatures, in contrast to some competitive brand and generic latanoprost and prostaglandin analogue products.

“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 that can cause discomfort for patients, frustration for physicians, and drive additional costs for payers,” she said.

The drug is expected to be available to eye care clinicians in the US during the second half of 2023.