FDA approves IYUZEH for IOP reduction in OAG, OHT

The U.S. Food and Drug Administration has approved the New Drug Application of IYUZEH (latanoprost ophthalmic solution; Théa Pharma, Inc) 0.005% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), according to a press release.

This is the only clinically proven formulation of latanoprost available in the United States that is preservative-free.

In randomized, controlled clinical trials, IYUZEH lowered IOP by 3-8 mmHg in patients with OAG or OHT with mean baseline IOP of 19-24 mmHg compared with 4-8 mmHg in patients treated with Xalatan 0.005%.

“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. 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,” said Susan Benton, Thea’s U.S. President in the press release.

Read the full press release here.