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Closing out 2022 with another FDA approval – Weekly Glance

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What is Iyuzeh?

Iyuzeh (eye-YOU-zuh) is latanoprost ophthalmic solution 0.005% indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.

What is unique about this version of latanoprost?

Iyuzeh is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free, according to Théa Pharmaceuticals.

Don't we already have a preservative-free formulation of latanoprost?

We don't; you might be thinking of latanoprost ophthalmic emulsion 0.005% (Xelpros), which was approved in 2018 as the only form of latanoprost not formulated with benzalkonium chloride (BAK).

How did Iyuzeh do in clinical trials?

In randomized controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline IOP of 19 mm Hg to 24 mm Hg, Iyuzeh lowered IOP by 3 mm Hg to 8 mmHg, compared with a 4 mm Hg to 8 mmHg reduction associated with latanoprost ophthalmic solution 0.005% (Xalatan), which is preserved with BAK.

When can we prescribe it?

Théa Pharmaceuticals says it plans on introducing Iyuzeh to US eye care practitioners in the second half of 2023. (via)