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Spotlight on IYUZEH™

Ophthalmology 360

This Spotlight Series article is editorially independent content.

Glaucoma is the leading cause of irreversible blindness globally. In the United States, it affects approximately 1900 of every 100,000 individuals older than 40 years.1 Lowering intraocular pressure (IOP) is the only known modifiable risk factor. Timely and effective reduction of IOP is essential for maintaining optic nerve health and visual field stability for this chronic condition.2 

IYUZEH™: Preservative-Free Formulation

In patients newly diagnosed with primary open-angle glaucoma (OAG) or ocular hypertension (OHT), initial treatment typically involves a single topical hypotensive medication. However, factors such as disease severity, extent of optic nerve damage, and patient age may warrant a more complex, multidrug regimen from the onset. Several classes of topical ocular hypotensive agents are available, each with different mechanisms of action. Prostaglandin agonist analogues are the most prescribed drug class because they are effective, generally better tolerated, and only require once-daily dosing.2

In 2023, the FDA approved IYUZEH (latanoprost ophthalmic solution; Thea Pharma Inc) 0.005%, a prostaglandin F2α analogue indicated for the reduction of elevated IOP in patients with OAG or OHT. It is the first and only preservative-free latanoprost option available in the United States. This preservative-free latanoprost, previously launched over a decade ago and is available in 46 countries under the brand MONOPROST®.3

Efficacy Data

The FDA approval was based on the formulation’s consistent IOP-lowering effects and proven tolerability across multiple trials in Europe and the United States.2,4,5

The randomized, controlled, phase 3 studies of patients with primary OAG or OHT compared IYUZEH and XALATAN (latanoprost ophthalmic solution, Pfizer Inc) 0.005%, which contains the preservative benzalkonium chloride, over 84 days. For patients who had mean baseline IOPs ranging from 19 to 24 mmHg, IYUZEH showed clinically meaningful reductions in IOP from baseline versus XALATAN (see FIGURE).2,5

*In the US clinical trial, the mean IOP baseline was 18.8 mmHg for IYUZEH (n=165) and 19.2 mmHg for XALATAN® (n=169) compared with 24.1 mmHg for IYUZEH (n=189) and 24 mmHg for XALATAN (n=164) in the European clinical trial, accounting for the smaller yet still clinically meaningful IOP-lowering effect.

Real-World Study

A real-world study assessed 1872 patients from 6 European countries who switched to preservative-free latanoprost ophthalmic solution 0.005% and were treated with it for at least 3 months or were treatment-naïve at the time of the study. The analysis found that patient satisfaction was very high.6

The percentage of patients satisfied with preservative-free latanoprost was comparable between those previously treated with preserved medications (95.3%; P<.0001) and treatment-naïve patients (97.3%). Furthermore, individual visual analog scores for tolerance improved, ranging from a 35% to 82% increase, depending on what previous preserved treatment was used (see FIGURE).6

VAS = visual analogue scale.
Based on results from a multicenter, international, transverse, epidemiological survey conducted in routine private ophthalmology practices to assess level of satisfaction among preservative-free latanoprost-treated patients.

 

Patient satisfaction was significantly associated with improved tolerance (P<.0001), high tolerability for those treated with preservative-free latanoprost (P<.0001), perceived ease of use (P<.0001), reduction of tear substitute use (P<.0001), and absence of ocular symptoms (P<.0004).6

Safety and Tolerability

IYUZEH has a demonstrated tolerability profile. In 2 clinical trials comparing IYUZEH with XALATAN, the most frequently reported ocular adverse events (AEs) were conjunctival hyperemia (34% vs 37%) and eye irritation (19% vs 31%).2,4

In the U.S. phase 3 study, AEs were generally mild to moderate and primarily ocular. IYUZEH was well-tolerated with fewer incidences of overall treatment-emergent AEs (TEAEs) versus XALATAN (13.9% vs 22.5%). The most frequently reported TEAEs were instillation site pain, conjunctival hyperemia, blepharitis, instillation site pruritus, and punctate keratitis.2

Dosing and Administration

IYUZEH is supplied in single-dose containers (30 per box), making it easier for patients to track doses to help ensure compliance. The recommended dosage is 1 drop in the affected eye or eyes once daily in the evening. If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. Contact lenses should be removed before administration of IYUZEH and may be reinserted 15 minutes after administration. If a dose is missed, treatment should continue with the next dose as normal.4

For more information, visit https://iyuzeh.com.

References

  1. The American Glaucoma Society (AGS). Unmet needs in the detection, diagnosis, monitoring, treatment, and understanding of primary open angle glaucoma. November 3, 2021. Accessed May 3, 2025. https://www.americanglaucomasociety.net/about/statements
  2. Bacharach J, Ahmed IIK, Sharpe ED, Korenfeld MS, Zhang S, Baudouin C. Preservative-free versus benzalkonium chloride-preserved latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension: a phase 3 US clinical trial. Clin Ophthalmol. 2023;17:2575-2588. doi:10.2147/OPTH.S414015
  3. Thea Pharma Inc. Launches IYUZEH™ (latanoprost ophthalmic solution) 0.005% in the U.S. News release. Thea Pharma Inc. September 26, 2023. Accessed May 5, 2025. https://www.multivu.com/players/English/9200651-thea-pharma-inc-launches-iyuzeh/
  4. IYUZEH. Package insert. Thea Pharma Inc; 2024.
  5. Rouland JF, Traverso CE, Stalmans I, et al; T2345 Study Group. Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma. Br J Ophthalmol. 2013;97(2):196-200. doi:10.1136/bjophthalmol-2012-302121
  6. Erb C, Stalmans I, Iliev M, Muñoz-Negrete FJ. Real-world study on patient satisfaction and tolerability after switching to preservative-free latanoprost. Clin Ophthalmol. 2021;15:931-938. doi:10.2147/OPTH.S295821

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