VYZULTA: Available in Pharmacies Nationwide.

VYZULTA – One Molecule. Two Pathways. Proven IOP Reduction.

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.1

 

There is no A/B generic equivalent for VYZULTA.

VYZULTA TARGETS BOTH PATHWAYS FOR IOP REDUCTION
  • Elevated lOP is largely due to cellular contraction in the presence of increased extracellular matrix deposition in the trabecular meshwork leading to decreased aqueous humor outflow
  • VYZULTA works to reduce lOP by increasing outflow through two pathways—the trabecular meshwork (primary outflow pathway) and the uveoscleral pathway (secondary pathway) 2-4

VYZULTA is metabolized into two moieties1,5,6

  • Latanoprost acid, a prostaglandin analog, works primarily within the uveoscleral pathway 2,7
  • Butanediol mononitrate releases nitric oxide, which is thought to relax the trabecular meshwork 8-11

Nitric oxide plays a role in controlling IOP8-11

  • Evidence of reduced levels of nitric oxide have been found in glaucoma patients' eyes12-14
  • A key role of endogenous nitric oxide is vascular smooth muscle relaxation to regulate blood flow
SEE HOW VYZULTA WORKS:
VYZULTA - PROVEN EFFICACY

VYZULTA QD achieved the primary objective of noninferiority to timolol 0.5% BID at all tested time points in 2 well-controlled, phase 3 clinical trials*

  • Superior IOP lowering with VYZULTA was demonstrated at Month 3
  • IOP-lowering effect was up to 7.5 to 9.1 mmHg in patients with an average baseline IOP of 26.7 mmHg1,15-17

*Primary endpoint: IOP measured at 9 assessment time points in study eye. Secondary endpoints: Change from baseline (CFB) in IOP at 9 assessment time points; CFB in diurnal IOP at Weeks 2 and 6 and Month 3. APOLLO study: VYZULTA 0.024% (n=284), timolol 0.5% (n=133); LUNAR study: VYZULTA 0.024% (n=274), timolol 0.5% (n=136).

P values obtained from superiority analysis (P<0.05, both studies).

VYZULTA (LBN 0.024%) demonstrated statistically significant greater mean IOP reduction compared with XALATAN (latanoprost) 0.005% at Day 2818

  • In the VOYAGER Phase 2 dose-ranging study, VYZULTA (LBN 0.024%) lowered mean diurnal IOP by 1.23 mmHg more than XALATAN (latanoprost) 0.005% at Day 28

Primary efficacy endpoint: Reduction in mean diurnal IOP at Day 28. VOYAGER study: once daily in the evening: LBN 0.024% (n=83), XALATAN (latanoprost) 0.005% (n=82; P=0.005).

PRODUCT INFORMATION1
  • Product trade name: VYZULTA
  • Delivery: Topical ophthalmic solution
  • Active ingredient: Latanoprostene bunod 0.24 mg/mL
  • Inactive ingredients: Polysorbate 80, glycerin, ethylenediaminetetraacetic acid (EDTA), water, benzalkonium chloride 0.2 mg/mL (preservative), citric acid/sodium citrate (to adjust the pH to 5.5)
  • How supplied: Natural low-density polyethylene, 7.5 mL bottle with dropper tip and a turquoise cap
  • Fill size: 5 mL

Packaging Specifications

Shipping case:

Pack
Dimensions
Weight
144
13.56" x 10.19" x 7"
6.25 lb

Selling unit:

Fill
NDC
Dimensions
Weight
5 mL
24208-0504-05
3.38" x 1.63" x 1.06"
22.68 gm
  • Bar coding: Bar-coded with NDC# 24208-504-05
  • Storage conditions: Unopened bottle should be stored refrigerated at 2° to 8°C (36° to 46°F). Once a bottle is opened, it may be stored at 2° to 25°C (36° to 77°F) for 8 weeks. Protect from light and freezing1
  • Expiration: 36 months
  • Inner pack: Shrink-wrapped in bundles of 12 units

For more information on VYZULTA, including dosing and administration, download the VYZULTA Pharmacy Information Sheet.

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INDICATION

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.

IMPORTANT SAFETY INFORMATION 
  • Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent
  • Gradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation
  • Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). VYZULTA should generally not be used in patients with active intraocular inflammation
  • Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema
  • There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients
  • Contact lenses should be removed prior to the administration of VYZULTA and may be reinserted 15 minutes after administration
  • Most common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%)
References
  1. VYZULTA Prescribing Information. Bausch & Lomb Incorporated. 2017.
  2. Braunger BM, Fuchshofer R, Tamm ER. The aqueous humor outflow pathways in glaucoma: a unifying concept of disease mechanisms and causative treatment.Eur J Pharm Biopharm. 2015;95(Pt B):173-181.
  3. Tamm ER, Braunger BM, Fuchshofer R. Intraocular pressure and the mechanisms involved in resistance of the aqueous humor flow in the trabecular meshwork outflow pathways. Prog Mol Biol Transl Sci. 2015;134:301-314.
  4. Winkler NS, Fautsch MP. Effects of prostaglandin analogues on aqueous humor outflow pathways. J Ocul Pharmacol Ther. 2014;30(2-3):102-109.
  5. Krauss AH, Impagnatiello F, Toris CB, et al. Ocular hypotensive activity of BOL-303259-X, a nitric oxide donating prostaglandin F2α agonist, in preclinical models. Exp Eye Res. 2011;93:250-255.
  6. Cavet ME, Vollmer TR, Harrington KL, VanDerMeid K, Richardson ME. Regulation of endothelin-1–induced trabecular meshwork cell contractility by latanoprostene bunod. Invest Ophthalmol Vis Sci. 2015;56(6):4108-4116.
  7. Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004;363:1711-1720.
  8. Cavet ME, Vittitow JL, Impagnatiello F, et al. Nitric oxide (NO): an emerging target for the treatment of glaucoma. Invest Ophthalmol Vis Sci. 2014;55:5005-5015.
  9. Buys ES, Potter LR, Pasquale LR, Ksander BR. Regulation of intraocular pressure by soluble and membrane guanylate cyclases and their role in glaucoma. Front Mol Neurosci. 2014;7:38. doi: 10.3389/fnmol.2014.00038.
  10. Schneemann A, Dijkstra BG, van den Berg TJ, et al. Nitric oxide/guanylate cyclase pathways and flow in anterior segment perfusion.Graefes Arch Clin Exp Ophthalmol. 2002;240:936-941.
  11. Wiederholt M, Sturm A, Lepple-Wienhues A. Relaxation of trabecular meshwork and ciliary muscle by release of nitric oxide. Invest Ophthalmol Vis Sci. 1994;35:2515-2520.
  12. Doganay S, Evereklioglu C, Turkoz Y, et al. Decreased nitric oxide production in primary open-angle glaucoma. Eur J Ophthalmol. 2002;12:44-48.
  13. Galassi F, Renieri G, Sodi A, et al. Nitric oxide proxies and ocular perfusion pressure in primary open angle glaucoma. Br J Ophthalmol. 2004;88:757-760.
  14. Nathanson JA, McKee M. Alterations of ocular nitric oxide synthase in human glaucoma. Invest Ophthalmol Vis Sci. 1995;36:1774-1784.
  15. Weinreb RN, Sforzolini BS, Vittitow J, Liebmann J. Latanoprostene bunod 0.024% versus timolol maleate 0.5% in subjects with open-angle glaucoma or ocular hypertension: the APOLLO study. Ophthalmology. 2016;123(5):965-973.
  16. Medeiros FA, Martin KR, Peace J, Sforzolini BS, Vittitow JL, Weinreb RN. Comparison of latanoprostene bunod 0.024% and timolol maleate 0.5% in open-angle glaucoma or ocular hypertension: the LUNAR study. Am J Ophthalmol. 2016;168:250-259.
  17. Data on File. Bausch & Lomb Incorporated.
  18. Weinreb RN, Ong T, Scassellati SB, et al. A randomised, controlled comparison of latanoprostene bunod and XALATAN (latanoprost) 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. June 2015;99(6):738-745.

SEE MORE

INDICATION

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.

IMPORTANT SAFETY INFORMATION 
  • Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent
  • Gradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation