Iyuzeh approved for IOP reduction in open-angle glaucoma, ocular hypertension
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The FDA approved Iyuzeh for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, according to a press release from Thea Pharma.
Iyuzeh (latanoprost ophthalmic solution 0.005%) is the first preservative-free formulation of latanoprost available in the U.S.
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In randomized, controlled clinical trials in patients with a mean baseline IOP of 19 mm Hg to 24 mm Hg, Iyuzeh lowered IOP by 3 mm Hg to 8 mm Hg while Xalatan (latanoprost ophthalmic solution 0.005%, Viatris), which is preserved with benzalkonium chloride, lowered IOP by 4 mm Hg to 8 mm Hg.
The most common ocular adverse events in the trials were conjunctival hyperemia (34% for Iyuzeh vs. 37% for Xalatan) and eye irritation (19% for Iyuzeh vs. 31% for Xalatan).
“Théa is responding to an important unmet need across all stakeholders in the treatment of [open-angle glaucoma] and [ocular hypertension],” Susan Benton, Thea’s U.S. president, said in the release. “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.”
Thea expects to introduce Iyuzeh to U.S. eye care practitioners in the second half of 2023.
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