Théa Pharma, Inc. announced phase 3 data supporting comparable efficacy of its Iyuzeh (latanoprost ophthalmic solution) 0.005% and Pfizer’s Xalatan (latanoprost ophthalmic solution) 0.005% for treated patients diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Tell me about Iyuzeh.
FDA approved in December 2022, the latanoprost ophthalmic solution 0.005% is the first—and currently only—preservative-free formulation indicated to lower IOP through a one-drop dosage into the affected eye(s), once a day (in the evening).
IOP reduction typically starts 3 to 4 hours after administration, and is present for at least 24 hours—with the maximum effect reached after 8 to 12 hours.
How about Xalatan?
Also a latanoprost ophthalmic solution 0.005%, Xalatan is indicated to treat high pressure/IOP via one drop in the affected eye(s) a day. However, unlike Iyuzeh, the formulation contains the preservative benzalkonium chloride (BAK).
Preservatives are known to potentially cause irritation in the eye (poor production and maintenance of the tear film), leading to dry eye symptoms and other negative side effects that might impact the ocular surface.
Talk about this study.
Investigators assessed Iyuzeh compared to Xalatan in 334 patients over an 84-day period.
Similar to Xalatan, Iyuzeh exhibited a clinically meaningful reduction in IOP from baseline (≤18 mmHg) with fewer ocular adverse events (13.9% vs. 22.5%). In all, less than 2% of Iyuzeh-treated patients reported instillation site pain, pruritus, or conjunctival hyperemia.
Théa did not report the number of patients treated with Iyuzeh vs Xalatan.
Significance of this data?
With a U.S. launch for Iyuzeh coming later in 2023, the formulation can be marketed as another potential option for IOP lowering in patients with POAG and OHT.