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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:
Yes. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
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.
IYUZEH demonstrated consistent IOP-lowering effects across multiple clinical and post-marketing trials in the U.S. 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.
Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active.
As a sterile solution in a translucent low-density polyethylene single-dose container packaged in foil pouches (5 single-dose containers per pouch).
No.
Contact lenses should be removed prior to the administration of IYUZEH and may be reinserted 15 minutes after administration.
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 non-inferiority 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.
IYUZEH™ (latanoprost ophthalmic solution) 0.005% is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Known hypersensitivity to latanoprost or any other ingredients in this product.
IYUZEH may cause changes to pigmented tissues. Most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as IYUZEH is administered. Iris pigmentation is likely to be permanent. Eyelid skin darkening and eyelash changes may be reversible.
IYUZEH may cause gradual change to eyelashes including increased length, thickness, and number of lashes. These changes are usually reversible upon discontinuation of treatment.
IYUZEH should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.
IYUZEH should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Reactivation of herpes simplex keratitis has been reported during treatment with latanoprost. IYUZEH should be used with caution in patients with a history of herpetic keratitis.
Contact lenses should be removed prior to the administration of IYUZEH and may be reinserted 15 minutes after administration.
The most common adverse reactions (5% to 35%) for IYUZEH are: conjunctival hyperemia, eye irritation, eye pruritus, abnormal sensation in eye, foreign body sensation in eyes, vision blurred, and lacrimation increased.
The combined use of two or more prostaglandins or prostaglandin analogs including IYUZEH is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.
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