The Food and Drug Administration (FDA) has approved Iyuzeh (latanoprost ophthalmic solution) 0.005% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Iyuzeh is a prostaglandin F2α analogue designed to reduce IOP by increasing the outflow of aqueous humor. The preservative-free product reduces IOP approximately 3 to 4 hours after administration with a maximum effect observed after 8 to 12 hours. 

The approval of Iyuzeh was based on randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline IOP of 19 to 24 mmHg. Findings showed that Iyuzeh lowered IOP by 3 to 8 mmHg compared with 4 to 8 mmHg with latanoprost ophthalmic solution preserved with benzalkonium chloride.

“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 US President. “We look forward to introducing Iyuzeh to US eyecare practitioners in the second half of 2023.”

References

  1. Thea Pharma announces FDA approval of Iyuzeh for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. News release. Thea Pharma. Accessed December 15, 2022. https://www.businesswire.com/news/home/20221215005312/en/Thea-Pharma-Announces-FDA-Approval-of-IYUZEH%E2%84%A2-for-the-Reduction-of-Elevated-Intraocular-Pressure-IOP-in-Patients-with-Open-angle-Glaucoma-or-Ocular-Hypertension.
  2. Iyuzeh. Package insert. Thea Pharma; 2022. Accessed December 15, 2022. https://iyuzeh.com/wp-content/uploads/2022/12/IYUZEH-Full-Prescribing-Information.pdf.