VYZULTA DELIVERED POWERFUL IOP REDUCTION ACROSS HIGH PRESSURE RANGES1-3*

In two pivotal Phase 3 studies, VYZULTA produced significant IOP reduction from baseline in high-pressure-range patients (mean diurnal IOP of 26.7 mmHg) as well as greater reduction from baseline vs timolol.1-3

9.1 IOP reduction
32% IOP reduction

Two Phase 3, randomized, multicenter, double-masked, parallel-group, 3-month studies were conducted comparing the IOP-lowering effect of once-daily VYZULTA vs twice-daily timolol 0.5% in patients with open-angle glaucoma or ocular hypertension: APOLLO (VYZULTA, n=284; timolol, n=133) and LUNAR (VYZULTA, n=278; timolol, n=136).2,3

*VYZULTA demonstrated a mean IOP reduction of 7.5-9.1 mmHg from baseline across 9 evaluated time points over 3 months.2,3

†Pooled analysis at Month 3 in both APOLLO and LUNAR studies. The primary efficacy endpoint in both studies was IOP measured at 8 am, 12 pm, and 4 pm at each post-baseline visit (Week 2, Week 6, and Month 3).2,3

 
40% IOP reduction
reduction icon

Post hoc analysis of the responder rates in patients (n=562, VYZULTA; n=269, timolol) at Week 12 in two Phase 3, randomized, multicenter, double-masked, parallel-group studies that compared VYZULTA with timolol (APOLLO and LUNAR). Mean percentage IOP reductions from mean baseline IOP occurred at one or more of the 8 am, 12 pm, or 4 pm assessment time points at the Month 3 visit. In the timolol group, mean IOP reductions of ≥40% from baseline occurred in 25.3% of patients.1,4

MORE HORSEPOWER TO LOWER IOP
VS XALATAN (LATANOPROST) 0.005%6,7

In the Phase 2 dose-ranging VOYAGER study, VYZULTA delivered significantly
greater mean IOP reduction vs Xalatan (latanoprost) 0.005%6,7:

IOP reduction vs XALATAN

A Phase 2, randomized, investigator-masked, parallel-group, dose-ranging study vs Xalatan in patients with open-angle glaucoma or ocular hypertension (n=413) to determine the optimal drug concentration of VYZULTA in reducing IOP. At day 28, there was a 47% difference between the number of patients who achieved an IOP of ≤18 mmHg with VYZULTA vs Xalatan (69% vs 48%, respectively).6

REAL-WORLD DATA FROM USE OF VYZULTA IN
TREATMENT-NAÏVE PATIENTS9,10

Recently published data from a real-world, multicenter retrospective chart review support the use of VYZULTA in treatment-naïve patients with open-angle glaucoma or ocular hypertension.10

reduction icon

Measurements taken during at least 2 follow-up visits (spanning at least 2 months) following initiation of treatment. Reductions shown are from second follow-up visit. In pivotal trials with baseline mean IOP of 26.7 mmHg, VYZULTA achieved 32% mean diurnal IOP reduction at Month 3. This study was subject to limitations inherent to its retrospective design and small sample size.1,2,9

POWERFUL IOP REDUCTION, INCLUDING IN
PATIENTS WITH LOW BASELINE PRESSURE

In a single-arm, long-term study of Japanese patients, VYZULTA consistently reduced mean IOP at all visits over 1 year.11

Reduction in mean IOP from baseline13
0.001 at all visits vs baseline
Low-pressure-range chart

EVERY MILLIMETER MATTERS WHEN PROTECTING VISION

RESULTS OF INDEPENDENT LANDMARK STUDIES (EMGT AND UKGTS) DEMONSTRATE THE VALUE OF VISUAL FIELD LOSS PREVENTION

Studies involved various glaucoma treatments, not including VYZULTA

EMGT - Early Manifest Glaucoma Trial; UKGTS - United Kingdom Glaucoma Treatment Study

EXCELLENT TOLERABILITY AND POWERFUL
EFFICACY ALL IN ONE DROP9,14

Medication-induced hyperemia is a factor in poor adherence, switching, and discontinuation of glaucoma treatment.15-17

safety icon
NO INCIDENCE OF TREATMENT-RELATED CORNEAL VERTICILLATE OR CONJUNCTIVAL HEMORRHAGE WAS OBSERVED9,14

VYZULTA was evaluated in 811 patients in Phase 3 studies lasting up to 12 months.9,14

*Pooled results from the APOLLO and LUNAR studies; ocular AEs occurring in ≥2% of VYZULTA study eyes.9

SEE WHAT YOUR PEERS ARE SAYING ABOUT THE
EFFICACY AND SAFETY OF VYZULTA

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VYZULTA clinical trial results: See what stood out to these eye care professionals

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What matters to an eye care professional when managing glaucoma, and how does this drop deliver?

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See the safety data of this once-nightly drop and why it can make a difference to an eye care professional

efficacy work
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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%)
PLEASE SEE FULL PRESCRIBING INFORMATION >

References: 1. Data on File. Bausch & Lomb Incorporated. 2. Weinreb RN, Scassellati Sforzolini B, 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. 3. Medeiros FA, Martin KR, Peace J, Scassellati Sforzolini B, 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. 4. Peace JH, Vittitow JL. Latanoprostene bunod ophthalmic solution 0.024% for IOP lowering in glaucoma: responder rates in phase 3 studies. Poster presented at: American Academy of Ophthalmology Meeting; October 15-18, 2016; Chicago, IL. Poster PO399. 5. Prum BE Jr, Rosenberg LF, Gedde SJ, et al. Primary open-angle glaucoma Preferred Practice Pattern® guidelines. Ophthalmology. 2016;123(1):P41-P111. 6. Weinreb RN, Ong T, Scassellati Sforzolini B, et al. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015;99(6):738-745. 7. Kaufman PL. Latanoprostene bunod ophthalmic solution 0.024% for IOP lowering in glaucoma and ocular hypertension. Expert Opin Pharmacother. 2017;18(4):433-444. 8. The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol. 2000;130(4):429-440. 9. VYZULTA Prescribing Information. Bausch & Lomb Incorporated. 10. Okeke CO, Burstein ES, Trubnik V, et al. Retrospective chart review on real-world use of latanoprostene bunod 0.024% in treatment-naïve patients with open-angle glaucoma. Ophthalmol Ther. 2020;9(4):1041-1053. 11. Kawase K, Vittitow JL, Weinreb RN, Araie M. JUPITER Study Group. Long-term safety and efficacy of latanoprostene bunod 0.024% in Japanese subjects with open-angle glaucoma or ocular hypertension: The JUPITER study. Adv Ther. 2016;33(9):1612-1627. 12. Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003;121(1):48-56. 13. Heijl A. Glaucoma treatment: by the highest level of evidence. Lancet. 2015;385(9975):1264-1266. 14. Weinreb RN, Liebmann JM, Martin KR, Kaufman PL, Vittitow JL. Latanoprostene bunod 0.024% in subjects with open-angle glaucoma or ocular hypertension: pooled phase 3 study findings. J Glaucoma. 2018;27(1):7-15. 15. Zimmerman TJ, Hahn SR, Gelb L, Tan H, Kim EE. The impact of ocular adverse effects in patients treated with topical prostaglandin analogs: changes in prescription patterns and patient persistence. J Ocul Pharmacol Ther. 2009;25(2):145-152. 16. Schwartz GF, Tan J, Kotak S. Hyperemia-associated costs of medication changes in glaucoma patients treated initially with prostaglandin analogs. J Ocul Pharmacol Ther. 2009;25(6):555-561. 17. Friedman DS, Hahn SR, Gelb L, et al. Doctor-patient communication, health-related beliefs, and adherence in glaucoma results from the Glaucoma Adherence and Persistency Study. Ophthalmology. 2008;115(8):1320-1327.e13273.

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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