Latanoprostene Bunod

Latanoprostene bunod is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Intraocular pressure is a major modifiable risk factor for glaucoma progression.

• VYZULTA ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.ICD-10: H40.059, H40.9

• None. None.contraindicated

The recommended dosage is one drop in the conjunctival sac of the affected eye(s) once daily in the evening. Do not administer VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% more than once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect. If VYZULTA is to be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure, administer each drug product at least five (5) minutes apart. One drop in the affected eye(s) once daily in the evening. ( 2 )

Pigmentation: Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent. ( 5.1 ) Eyelash changes: Gradual changes to eyelashes including increased length, increased thickness and number of eyelashes. Usually reversible upon discontinuation of treatment. ( 5.2 ) 5.1 Pigmentation VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% may cause changes to pigmented tissues. The most frequently reported changes with prostaglandin analogs have been increased pigmentation of the iris and periorbital tissue (eyelid). Pigmentation is expected to increase as long as latanoprostene bunod ophthalmic solution is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of VYZULTA, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients. Patients who receive prostaglandin analogs, including VYZULTA, should be informed of the possibility of increased pigmentation, including permanent changes. The long-term effects of increased pigmentation are not known. 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. Neither nevi nor freckles of the iris appear to be affected by treatment.

The following adverse reactions are described elsewhere in the labeling: Pigmentation [see Warnings and Precautions (5.1) ] Eyelash Changes [see Warnings and Precautions (5.2) ] Intraocular Inflammation [see Warnings and Precautions (5.3) ] Macular Edema [see Warnings and Precautions (5.4) ] Bacterial Keratitis [see Warnings and Precautions (5.5) ] Use with Contact Lens [see Warnings and Precautions (5.6) ] Most common ocular adverse reactions with incidence ≥ 2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. VYZULTA was evaluated in 811 patients in 2 controlled clinical trials of up to 12 months duration. The most common ocular adverse reactions observed in patients treated with latanoprostene bunod were: conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). Approximately 0.6% of patients discontinued therapy due to ocular adverse reactions including ocular hyperemia, conjunctival irritation, eye irritation, eye pain, conjunctival edema, vision blurred, punctate keratitis and foreign body sensation.

8.1 Pregnancy Risk Summary There are no available human data for the use of VYZULTA during pregnancy to inform any drug associated risks. Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. Latanoprostene bunod was shown to be abortifacient and teratogenic when administered intravenously (IV) to pregnant rabbits at exposures ≥ 0.28 times the clinical dose. Doses ≥ 20 mcg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality. Structural abnormalities observed in rabbit fetuses included anomalies of the great vessels and aortic arch vessels, domed head, sternebral and vertebral skeletal anomalies, limb hyperextension and malrotation, abdominal distension and edema. Latanoprostene bunod was not teratogenic in the rat when administered IV at 150 mcg/kg/day (87 times the clinical dose) [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 19, to target the period of organogenesis. The doses administered ranged from 0.24 to 80 mcg/kg/day.

Metabolism

Absorption The systemic exposure of latanoprostene bunod and its metabolites latanoprost acid and butanediol mononitrate were evaluated in one study with 22 healthy subjects after topical ocular administration of VYZULTA 0.024% once daily (one drop bilaterally in the morning) for 28 days. There were no quantifiable plasma concentrations of latanoprostene bunod (lower limit of quantitation, LLOQ, of 10.0 pg/mL) or butanediol mononitrate (LLOQ of 200 pg/mL) post-dose on Day 1 and Day 28.

• Nov 2, 2017NDANDA207795Bausch And Lomb
• Apr 29, 2025ANDAANDA217387Gland

1. 1Eye Pain10511%
2. 2Eye Irritation949.4%
3. 3Ocular Hyperaemia757.5%
4. 4Intraocular Pressure Increased585.8%
5. 5Drug Ineffective505.0%
6. 6Off Label Use474.7%
7. 7Vision Blurred444.4%
8. 8Fatigue424.2%
9. 9Headache404.0%
10. 10Death393.9%
11. 11Visual Impairment393.9%
12. 12Pain343.4%
13. 13Product Quality Issue343.4%
14. 14Product Dose Omission Issue323.2%
15. 15Dizziness313.1%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Latanoprostene Bunod as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension
  Withdrawn · Phase 4 · Interventional · 0 enrolled · Bausch & Lomb Incorporated
  NCT04140279updated 2024-03-04
• Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity
  Completed · Interventional · 70 enrolled · University of California, San Diego
  NCT03931317updated 2023-08-29
• Nailfold Capillary Blood Flow With Latanoprost Bunod
  Completed · Phase 4 · Interventional · 47 enrolled · Icahn School of Medicine at Mount Sinai
  NCT03949244updated 2021-09-29
• Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
  Completed · Phase 3 · Interventional · 420 enrolled · Bausch & Lomb Incorporated
  NCT01749930updated 2018-11-21
• Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
  Completed · Phase 3 · Interventional · 420 enrolled · Bausch & Lomb Incorporated
  NCT01749904updated 2018-11-07
• BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
  Completed · Phase 2 · Interventional · 25 enrolled · Bausch & Lomb Incorporated
  NCT01707381updated 2018-09-04
• Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
  Completed · Phase 3 · Interventional · 130 enrolled · Bausch & Lomb Incorporated
  NCT01895972updated 2018-07-26
• Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension
  Completed · Phase 2 · Interventional · 413 enrolled · Bausch & Lomb Incorporated
  NCT01223378updated 2018-07-24
• Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers
  Completed · Phase 1 · Interventional · 24 enrolled · Bausch & Lomb Incorporated
  NCT01895985updated 2018-05-15

Frequently asked questions

How does Latanoprostene Bunod work?

Latanoprostene bunod is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Intraocular pressure is a major modifiable risk factor for glaucoma progression.

What is Latanoprostene Bunod used for?

According to FDA labeling, Latanoprostene Bunod carries indications including: VYZULTA ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Latanoprostene Bunod?

Latanoprostene Bunod is classified as Prostaglandin analogues.

What are the brand names for Latanoprostene Bunod?

Latanoprostene Bunod is marketed under brand names including Vyzulta.

What are the contraindications for Latanoprostene Bunod?

Latanoprostene Bunod labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.