FDA Approves Iyuzeh to Reduce Intraocular Pressure

Iyuzeh is a preservative-free formulation of latanoprost and doesn’t need to be stored at refrigerated temperatures. It will be available in the second half of 2023.

The FDA has approved new drug application (NDA) of Thea Pharma’s Iyuzeh (latanoprost ophthalmic solution) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Iyuzeh is a preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue. It does not need to be manufactured, distributed, or stored at refrigerated temperatures unlike some other competitive brand and generic latanoprost and prostaglandin products. Company executives said Iyuzeh will be available in the second half of 2023.

“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,” said Susan Benton, Thea’s U.S. president, said in a press release.

In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension, Iyuzeh lowered intraocular pressure by 3 – 8 mmHg compared with 4 – 8 mmHg by Viatris’ Xalatan (latanoprost ophthalmic solution), which is preserved with benzalkonium chloride.