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Nitric Oxide-donating Prostaglandin Analogue — Glaucoma Pregnancy: US labelling: there are no available human data for use during pregnancy to inform any drug-associated risks. Latanoprostene bunod caused miscarriages, abortion and fetal harm in rabbits - it was abortifacient and teratogenic when given intravenously to pregnant rabbits at exposures of 0.28 times the clinical dose or more, with 100% embryofetal lethality at doses of 20 mcg/kg/day or more (23 times the clinical dose); structural abnormalities included anomalies of the great vessels and aortic arch vessels, domed head and skeletal anomalies. It was not teratogenic in the rat at 150 mcg/kg/day IV (87 times the clinical dose). Lactation: there are no data on the presence of latanoprostene bunod in human milk, the effects on the breastfed infant or on milk production; the developmental and health benefits of breastfeeding should be considered with the mother's clinical need for the drug and any potential adverse effects on the breastfed infant.

Latanoprostene Bunod 0.024% Eye Drops

Brand names: Vyzulta

Latanoprostene bunod is a topical eye drop used once daily to lower intraocular pressure in open-angle glaucoma and ocular hypertension.

Adult dose

Dose: Reduction of intraocular pressure in open-angle glaucoma or ocular hypertension: 1 drop in the conjunctival sac of the affected eye(s) once daily in the evening
Route: Topical ophthalmic (conjunctival sac of the affected eye)
Frequency: Once daily, in the evening
Max: 1 drop once daily - the label states not to administer more than once daily
More frequent administration of prostaglandin analogues may lessen the intraocular pressure lowering effect. If used with other topical ophthalmic drugs to lower intraocular pressure, administer each product at least 5 minutes apart. Contact lenses should be removed before administration (the product contains benzalkonium chloride) and may be reinserted 15 minutes afterwards. Unopened bottle: store refrigerated at 2° to 8°C; once opened it may be stored at 2° to 25°C for 8 weeks. Use in paediatric patients aged 16 years and younger is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use - for children use a children's formulary. No UK SPC for latanoprostene bunod eye drops is listed on eMC — this dose is from US prescribing information (Latanoprostene Bunod Ophthalmic Solution, 0.024%, Gland Pharma Limited) and must be verified against UK practice.

Dose adjustments

Renal

Not addressed in the US labelling retrieved for this page.

Hepatic

Not addressed in the US labelling retrieved for this page.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • None listed in the US labelling

Side effects

  • Conjunctival hyperaemia (6%)
  • Eye irritation (4%)
  • Eye pain (3%)
  • Instillation site pain (2%)
  • Increased pigmentation of the iris and periorbital tissue (eyelid) - iris pigmentation is likely to be permanent; periorbital pigmentation and eyelash changes are likely to be reversible in most patients
  • Gradual changes to eyelashes and vellus hair in the treated eye (increased length, thickness and number); usually reversible on discontinuation
  • May exacerbate active intraocular inflammation (iritis/uveitis)
  • Macular oedema, including cystoid macular oedema, has been reported during treatment with prostaglandin analogues
  • Bacterial keratitis has been reported with multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients
  • Approximately 0.6% of patients discontinued therapy due to ocular adverse reactions (ocular hyperaemia, conjunctival irritation, eye irritation, eye pain, conjunctival oedema, blurred vision, punctate keratitis, foreign body sensation)

Interactions

  • Other topical ophthalmic drugs used to lower intraocular pressure: administer each product at least 5 minutes apart

Monitoring

  • Patients who develop noticeably increased iris pigmentation can continue treatment but should be examined regularly
  • Use with caution in patients with a history of intraocular inflammation (iritis/uveitis); generally do not use in active intraocular inflammation
  • Use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or those with known risk factors for macular oedema
  • Advise patients about the possibility of increased pigmentation, including permanent iris colour change, which may not be noticeable for several months to years

Clinical monograph

How it works

It is metabolised in the eye to latanoprost acid, a prostaglandin analogue that increases uveoscleral outflow, and to butanediol mononitrate, which releases nitric oxide to enhance trabecular meshwork outflow, together reducing intraocular pressure.

Prescribing in practice

  • Like other prostaglandin analogues it can cause permanent changes in iris colour and periorbital tissue and increased eyelash growth, which should be discussed before starting, and it is for once-daily evening use only.
  • Use with caution in patients with active intraocular inflammation, aphakia or known risk factors for macular oedema.
  • Remove contact lenses before instillation and reinsert after the recommended interval; if other intraocular pressure-lowering drops are used, separate their administration.

Monitoring

Monitor intraocular pressure regularly to assess treatment response and review the eye for iris or periorbital pigmentary changes and any signs of intraocular inflammation.

Counselling the patient

  • Use one drop in the affected eye(s) in the evening and do not exceed once-daily dosing, as more frequent use may reduce the pressure-lowering effect.
  • Be aware that darkening of the iris and eyelid skin and longer, darker eyelashes can occur, and iris colour change may be permanent.

Evidence & guidelines

Prostaglandin analogues are recommended first-line for lowering intraocular pressure in open-angle glaucoma and ocular hypertension by NICE guidance (NG81).

Reference: APOLLO Trial (Am J Ophthalmol 2016); LUNAR Trial (Am J Ophthalmol 2016); EGS Glaucoma Guidelines 2020; SPC Vyzulta; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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