Thea Pharma, Inc. announced the presentation of phase 3 data on Iyuzeh (latanoprost ophthalmic solution) 0.005% by Jason Bacharach, MD, at the 2023 American Glaucoma Society (AGS) annual meeting. The large, pivotal clinical trial demonstrated comparable efficacy of preservative-free Iyuzeh (latanoprost ophthalmic solution) 0.005% over brand-name Xalatan (Pfizer Inc) (latanoprost ophthalmic solution) 0.005%, containing the preservative benzalkonium chloride (BAK), in patients with POAG or OHT.
“We compared Iyuzeh to Xalatan in 334 patients over 84 days,” said Bacharach, founder and Director of Research at North Bay Eye Associates in Petaluma, California. “ Iyuzeh demonstrated similar clinically meaningful reductions in IOP from baseline (≤18 mmHg) with fewer ocular adverse events (13.9% vs. 22.5%). Less than 2% of patients in the IYUZEH group experienced instillation site pain, pruritis or conjunctival hyperemia.”
“The harmful effects of preservatives on ocular surface health are well documented,” Susan Benton, president of Thea Pharma, Inc., added, “We have solved the challenge of creating a room temperature-stable, efficacious, and preservative-free latanoprost eye drop. Iyuzeh brings the IOP-lowering efficacy of latanoprost and eliminates the exposure to preservatives for patients with glaucoma or ocular hypertension.”
Iyuzeh has been marketed outside of US under the brand name Monoprost in 46 countries. About 1.5 million patients are currently treated with Monoprost, which was launched 10 years ago. Ophthalmologists and optometrists in the U.S. market can thus be confident in the efficacy, safety, and tolerability of prescribing Iyuzeh to their patients with POAG or OHT when we launch later this year.
AGS 2023 attendees and virtual registrants may view Dr. Bacharach’s presentation as part of the poster on-demand section of the meeting.
About Iyuzeh
Iyuzeh (latanoprost ophthalmic solution) 0.005%, an opalescent, white to slightly yellow ophthalmic solution, is a topical formulation of latanoprost that is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Iyuzeh does not contain a preservative—it is the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA) in the United States.
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.
In the two clinical trials conducted with Iyuzeh (latanoprost ophthalmic solution) 0.005%, the most frequently reported ocular adverse reactions were conjunctival hyperemia (34%) and eye irritation (19%) compared to Xalatan, the preserved 0.005% latanoprost reference product which reported conjunctival hyperemia (37%) and eye irritation (31%).