Iyuzeh®
Latanoprost 0.005% · preservative-free ophthalmic solution
Antiglaucoma
Approved uses
Open-angle glaucoma or ocular hypertension
One drop in the affected eye(s) once daily in the evening; not to exceed once daily.
IOP starts falling 3 to 4 hours after instillation, peaks at 8 to 12 hours, and stays reduced 24 hours.
OFF-LABELNot in the FDA label for this product
Chronic angle-closure glaucoma
One drop once daily in the evening, the same regimen as the labeled indication (dosed at 9 PM in the trial).
RCT · n=275 · preserved drug
Randomized, double-masked, 12-week multicenter trial in chronic angle-closure glaucoma (latanoprost n=137, timolol n=138): mean change in daily IOP was -8.2 mmHg vs -5.2 mmHg on timolol BID, difference -3.0 mmHg (95% CI -4.0 to -2.1), P<0.001, favoring latanoprost. Studied with preserved latanoprost, not with this preservative-free formulation.
Pediatric glaucoma
Latanoprost 0.005%, one drop once daily at 8 PM (dose used in the trial, ages 0 to 18 years).
RCT · n=137 · not superior
Phase 3, randomized, double-masked, 12-week multicenter trial, 137 treated: mean IOP reduction at week 12 was 7.2 mmHg vs 5.7 mmHg on timolol, difference 1.5 mmHg (95% CI -0.8 to 3.7, P=0.21), meeting the noninferiority margin without showing superiority; responders 60% vs 52% (P=0.33), both well tolerated over 3 months. Studied with preserved latanoprost; this label states pediatric safety and effectiveness are not established.
Contraindications
Known hypersensitivity to latanoprost or any other ingredient in this product.
Available Forms0.005% (50 mcg/mL) preservative-free ophthalmic solution, 0.2 mL single-dose containers, carton of 30, 5 containers per foil pouch
Mechanism of ActionProstaglandin F2alpha analogue supplied as an isopropyl ester prodrug that corneal esterases hydrolyze to the active acid; IOP falls mainly through increased uveoscleral outflow, which class reviews attribute to matrix metalloproteinase remodeling that widens the spaces between ciliary muscle fibers. Onset is 3 to 4 hours after instillation, maximum effect 8 to 12 hours, and IOP reduction persists at least 24 hours.
Warnings & Precautions
- Iris pigmentation: Brown pigmentation spreads concentrically from the pupil and increases as long as treatment continues; it is likely permanent after discontinuation, so examine these patients regularly. Iris nevi and freckles do not appear to be affected.
- Periorbital and lash changes: Eyelid skin darkening plus increased eyelash length, thickness, pigmentation, number, and misdirected growth in the treated eye; reported reversible in some patients after discontinuation.
- Intraocular inflammation: Caution with a history of iritis or uveitis, and generally not for use with active intraocular inflammation, which may be exacerbated.
- Macular edema: Macular edema including cystoid macular edema has been reported; caution in aphakia, in pseudophakia with a torn posterior lens capsule, and with other known risk factors.
- Herpetic keratitis: Reactivation of herpes simplex keratitis has been reported; caution with a history of it and avoid in active herpes simplex keratitis, which may be exacerbated.
- Prostaglandin duplication: Dosing more than once daily, or combining two or more prostaglandins or prostaglandin analogs, may decrease the IOP lowering effect or cause paradoxical IOP elevation.
- Thimerosal-containing drops: Precipitation occurred in vitro when thimerosal drops were mixed with the preserved 0.005% latanoprost reference product; separate concurrent topical drops by at least 5 minutes.
Common Side Effects
- Ocular, clinical trials: conjunctival hyperemia 34%, eye irritation 19%, eye pruritus 15%, abnormal sensation in eye 14%, foreign body sensation 12%, blurred vision 7%, increased lacrimation 5%, photophobia 3% (n=378).
- Ocular, pigment and lash changes: increased brown iris pigmentation, eyelid skin darkening, and longer, thicker, darker, more numerous eyelashes and vellus hair in the treated eye.
- Ocular, serious: intraocular inflammation (iritis/uveitis), macular edema including cystoid macular edema, herpes simplex keratitis, keratitis, corneal edema and erosions, deepening of the eyelid sulcus, trichiasis, iris cyst, pseudopemphigoid of the conjunctiva (postmarketing, frequency not established).
- Systemic: asthma and asthma exacerbation, dyspnea, headache, dizziness, angina, unstable angina, palpitations, chest pain, nausea, vomiting, toxic epidermal necrolysis (postmarketing, frequency not established).
Pregnancy & LactationPregnancy: No adequate and well-controlled studies in pregnant women. IV latanoprost given to pregnant rabbits and rats through organogenesis produced malformations, embryofetal lethality, and abortion at 1.3 to 324 times the maximum recommended human ophthalmic dose.
Lactation: Excretion in human milk is unknown; weigh the benefits of breastfeeding against maternal need and potential effects on the breastfed infant.
Pediatric UseSafety and effectiveness not established in pediatric patients.