Frequently Asked Questions about IYUZEH™

Considering prescribing IYUZEH (latanoprost ophthalmic solution) 0.005% for your patients? Find answers to common questions and considerations

Descriptions of IYUZEH

No. IYUZEH is a topical, preservative-free formulation of latanoprost ophthalmic solution 0.005%. XELPROS contains potassium sorbate as a preservative.

While both IYUZEH and ZIOPTAN are indicated to lower intraocular pressure (IOP), they differ by the following:

  • Active ingredient: IYUZEH is latanoprost whereas tafluprost is the active ingredient of ZIOPTAN. Both have active ingredients that are prostaglandin analogs.
  • Chemical structure: The major modification of ZIOPTAN (tafluprost) is the substitution of the C-15 hydroxyl group with two fluorine atoms.
  • Vehicle: IYUZEH is composed of Polyoxyl 40 hydrogenated castor oil, sorbitol, carbomer 974P, polyethylene glycol 4000, disodium edetate, sodium hydroxide (for pH adjustment), and water for injection. The vehicle for ZIOPTAN contains glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH), and water for injection.
  • Storage: Unopened foil pouches of IYUZEH can be stored at room temperature prior to opening; however, ZIOPTAN must be refrigerated prior to opening.

Dosing Instructions/Drug Interactions

Yes. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Warnings and Precautions

Possibly. Topical latanoprost ophthalmic products, including IYUZEH, have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase while latanoprost is administered. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris, and the entire iris or parts of the iris become more brownish.

After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Neither nevi nor freckles of the iris appear to be affected by treatment. The long-term effects of increased pigmentation are unknown.

Possibly. Latanoprost ophthalmic products, including IYUZEH, may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of the eyelashes.

Eyelash changes are usually reversible upon treatment discontinuation.

Clinical Pharmacology

IYUZEH demonstrated consistent IOP-lowering effects across multiple clinical and post-marketing trials in the US and Europe. In a randomized, controlled clinical trial, conducted in the US (n=335), of patients with OAG or OHT with mean baseline IOP of 19-24 mmHg, IYUZEH lowered IOP by 3-8 mmHg versus 4-8 mmHg by XALATAN® (latanoprost ophthalmic solution) 0.005%, which is preserved with BAK.

Reduction of the IOP in patients starts about 3-4 hours after administration and maximum effect is reached after 8-12 hours.

IOP reduction is present for at least 24 hours.

Pharmacokinetics

Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active.

Supply and Storage

As a sterile solution in a translucent low-density polyethylene single-dose container packaged in foil pouches (5 single-dose containers per pouch).

No.

Use in Specific Populations

Contact lenses should be removed prior to the administration of IYUZEH and may be reinserted 15 minutes after administration.

Clinical Trials

Patients treated with either IYUZEH or XALATAN® provided clinically meaningful reductions in IOP from baseline to all follow-up visits and time points (n=335). At day 84, the mean ± SD diurnal IOP was 16.3±2.5 mmHg in the IYUZEH group and 15.7±2.6 mmHg in the XALATAN group, representing percentage IOP decreases of 13.8% and 17.7%, respectively.

For the primary efficacy endpoint, the two-sided 95% CI of both IYUZEH and XALATAN were within 1.5 mmHg for all time points (9/9) assessed in the study eye of the Per Protocol population. However, only 1/9 time points (day 84, 4 PM) was within the noninferiority margin of 1.0 mmHg, with 4/9 time points exceeding this noninferiority margin by 0.07 mmHg or less.

Treatment withdrawals occurred for IYUZEH at a rate comparable to the other prostaglandins studied. In both pivotal Phase 3 studies, there were 10 subjects in the IYUZEH groups (2.6%) where treatment was withdrawn, and 7 in the XALATAN group (2.0%).

In this clinical trial, 1.8% of patients in both the IYUZEH and the XALATAN groups discontinued treatment, with the most common reasons for early discontinuation from the study being TEAEs and consent withdrawal.

It was the between-group comparison of the mean change in IOP values from baseline in the study eye at each time point (8 AM, 10 AM, 4 PM; ±30 minutes) at day 15, 42, and 84 visits, as measured by tonometry.