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Medications›Antiglaucoma›Vyzulta

Vyzulta®

GoodRx

Latanoprostene Bunod 0.024% · ophthalmic solution

Antiglaucoma

Approved uses

Open-angle glaucoma or ocular hypertension

One drop in the conjunctival sac of the affected eye(s) once daily in the evening; not to exceed once daily.

About 35% hold a 25% or greater IOP reduction, maintained through 12 months.

Contraindications

None.

Available Forms

0.024% (0.24 mg/mL) ophthalmic solution, 2.5 mL fill in a 4 mL container, 5 mL fill in a 7.5 mL container

Mechanism of Action

Nitric oxide donating prostaglandin analog, hydrolyzed in the eye to latanoprost acid, which increases uveoscleral outflow, and to butanediol mononitrate, which releases nitric oxide and increases outflow through the trabecular meshwork. IOP begins to fall 1 to 3 hours after the first dose, with maximum effect at 11 to 13 hours.

Warnings & Precautions

Iris pigmentation: Brown pigmentation spreads concentrically from the pupil and increases as long as dosing continues, from increased melanin content in melanocytes rather than more melanocytes; it is likely permanent after discontinuation, so examine these patients regularly. Nevi and freckles of the iris appear unaffected, and the long-term effects of increased pigmentation are not known.

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Periorbital pigmentation: Eyelid tissue darkening is likely reversible in most patients after discontinuation, unlike the iris change.

Eyelash changes: Gradual increase in eyelash and vellus hair length, thickness, and number in the treated eye, usually reversible after discontinuation; unilateral use can leave a disparity between eyes in length, thickness, pigmentation, number, and growth direction.

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 with prostaglandin analogs; caution in aphakia, in pseudophakia with a torn posterior lens capsule, and with other known risk factors.

Bacterial keratitis: Reported with inadvertently contaminated multiple-dose containers, in most cases in patients with concurrent corneal disease or a disrupted ocular epithelial surface.

Benzalkonium chloride: Preserved with benzalkonium chloride 0.2 mg/mL; remove contact lenses before instillation and reinsert 15 minutes after.

Common Side Effects

Ocular, 2% or more: conjunctival hyperemia 6%, eye irritation 4%, eye pain 3%, instillation site pain 2% (811 patients in 2 controlled trials of up to 12 months).
Discontinuation: about 0.6% stopped for ocular reactions including ocular hyperemia, conjunctival irritation, eye irritation, eye pain, conjunctival edema, blurred vision, punctate keratitis, and foreign body sensation.
Ocular, pigment and lash changes: increased iris and periorbital (eyelid) pigmentation, and increased eyelash and vellus hair length, thickness, and number in the treated eye.
Ocular, serious: intraocular inflammation (iritis/uveitis), macular edema including cystoid macular edema, and bacterial keratitis associated with contaminated multiple-dose containers.

Pregnancy & Lactation

Pregnancy: No available human data. IV dosing in pregnant rabbits during organogenesis was abortifacient and teratogenic at exposures 0.28 times the clinical dose and above, with 100% embryofetal lethality at 23 times and malformations including aortic coarctation, domed head, sternebral and vertebral anomalies, and limb hyperextension; not teratogenic in rats at 87 times the clinical dose, with embryofetal lethality and anomalies at 174 times.

Lactation: No data on presence in human milk, effects on the breastfed infant, or effects on milk production.

Pediatric Use

Not recommended at 16 years of age and younger because of pigmentation risk with long-term chronic use.

Vyzulta (Latanoprostene Bunod 0.024%) | EyeKnow O.D.