
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
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
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
In the Phase 2 dose-ranging VOYAGER study, VYZULTA delivered significantly
greater mean IOP reduction vs Xalatan (latanoprost) 0.005%6,7:
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
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
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
In a single-arm, long-term study of Japanese patients, VYZULTA consistently reduced mean IOP at all visits over 1 year.11
EMGT - Early Manifest Glaucoma Trial; UKGTS - United Kingdom Glaucoma Treatment Study
Medication-induced hyperemia is a factor in poor adherence, switching, and discontinuation of glaucoma treatment.15-17
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
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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.
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.
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.