Thea Pharma Inc. has announced US Food and Drug Administration (FDA) approval of the New Drug Application for Iyuzeh topical prostaglandin analogue (latanoprost ophthalmic solution 0.005%) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Iyuzeh is the first and only clinically proven formulation of latanoprost available in the United States that is preservative free. The drug is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK).
Iyuzeh demonstrated consistent IOP-lowering effects and proven tolerability across multiple trials in the United States and Europe. In randomized, controlled clinical trials of patients with OAG or OHT with mean baseline IOP of 19 mmHg to 24 mmHg, Iyuzeh lowered IOP by 3 mmHg to 8 mmHg. The reference product Xalatan (latanoprost ophthalmic solution) 0.005%, which is preserved with BAK, lowered IOP by 4 mmHg to 8 mmHg. In the 2 clinical trials conducted with Iyuzeh, the most frequently reported ocular adverse reactions were conjunctival hyperemia in 34% of patients and eye irritation in 19% of patients compared to Xalatan, which reported conjunctival hyperemia in 37% and eye irritation in 31%.
“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 US subsidiary,” said Jean-Frédéric Chibret, President of the Théa Group, in a news release. “Marketed outside of the US as Monoprost, the market 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.”
The patent-protected formulation of Iyuzeh was developed to solve the challenges of solubilizing and stabilizing latanoprost so 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, Chibret added.
“Additionally, Théa is responding to an important unmet need across all stakeholders in the treatment of OAG and OHT,” said Susan Benton, Thea’s US president. “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. We look forward to introducing Iyuzeh to US eye care practitioners in the second half of 2023.”
