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FDA approves Théa Pharma’s Iyuzeh for glaucoma

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Théa Pharmaceuticals has received FDA approval for Iyuzeh (latanoprost ophthalmic solution) 0.005% for elevated intraocular pressure (IOP) reduction in open-angle glaucoma and ocular hypertension.

What is unique about Iyuzeh?

Iyuzeh (EYE-YOU-ZUH) is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free.

How does it work?

The formulation is designed as a single dosage to be placed in the eye(s) once daily in the evening. After administration, IOP reduction takes approximately 3 to 4 hours to begin. The maximum level of effect takes place after 8 to 12 hours. From start to finish, IOP reduction remains for at least 24 hours. (via)

What did clinical trials show?

Two randomized clinical trials found that Iyuzeh lowered IOP by 3 to 8 mmHg in comparison to 4 to 8 mmHg by a preservative-formulated solution (benzalkonium chloride). The most common adverse reactions reported were conjunctival hyperemia (34%) and eye irritation (19%).

When can we prescribe this?

Théa expects to commercially launch Iyuzeh in the U.S. by the second half of 2023.