The FOOD AND DRUG ADMINISTRATION 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 particular FDA approval was based on the formulation’s consistent IOP-lowering effects and confirmed tolerability across multiple trials in the particular US and Europe. In randomized, controlled clinical tests 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 in order to 8 mmHg by XALATAN(latanoprost ophthalmic solution, Pfizer) 0. 005%, whichcontains the preservative benzalkonium chloride.
The IOP-lowering effect associated with the drug lasts 24 hours with 1 fall instilled at bedtime. The effect begins 3 to 4 hours after instillation plus peaks in 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 associated with solubilizing plus stabilizing latanoprost, in that will IYUZEH does not require manufacturing, distribution, or storage at refrigerated temperatures, in contrast to some competitive brand in addition to 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 even symptoms regarding ocular surface disease of which can cause discomfort for patients, frustration for physicians, together with drive additional costs with regard to payers, ” she said.
The medication is expected to be available to eye care clinicians in the particular US during the second half of 2023.