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Thea Pharma Announces FDA Approval of Glaucoma Drug Iyuzeh

Thea Pharma Announces FDA Approval of Glaucoma Drug Iyuzeh

December 16, 2022

The U.S. Food and Drug Administration (FDA) has recently approved Thea Pharma's new glaucoma drug, Iyuzeh (latanoprost ophthalmic solution) 0.005% for the treatment of reduction of elevated IOP in patients with open-angle glaucoma and ocular hypertension. Iyuzeh does not contain preservatives, and it is the first and only preservative-free formulation of latanoprost in the US.

Open-angle glaucoma is a chronic condition that damages the optic nerve, leading to vision loss and blindness. It is typically caused by an increase in intraocular pressure (IOP), or pressure inside the eye. Ocular hypertension is a condition in which the IOP is consistently higher than normal, but there is no evidence of optic nerve damage.

The preservatives frequently found in topical ocular medicines, such as benzalkonium chloride, are not included in the formulation of Iyuzeh (BAK). Iyuzeh has consistently lowered IOP and been shown to be tolerable in numerous trials in the US and Europe. In randomized, controlled clinical studies, Iyuzeh reduced IOP by 3–8 mmHg against 4–8 mmHg by Xalatan (latanoprost ophthalmic solution) at 0.005%, which is preserved with BAK, in patients with open-angle glaucoma or ocular hypertension and mean baseline IOP of 19–24 mmHg.

The recommended dosage of IYUZEH™ is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. IOP reduction is present for at least 24 hours.

“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,” Jean-Frédéric Chibret, President of the Théa Group, said in a company news release. “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. 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," Susan Benton, Thea’s U.S. President, said in the news release.

"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. We look forward to introducing Iyuzeh to U.S. eyecare practitioners in the second half of 2023,” she further added.