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VYZULTA delivered up to a 9.1 mmHg mean IOP reduction from baseline in pivotal trials vs up to an 8.0 mmHg mean reduction in timolol patients. In APOLLO, baseline mean diurnal IOP in patients on VYZULTA was 26.7 mmHg vs 26.5 mmHg in patients on timolol 0.5%, respectively. In LUNAR, baseline mean diurnal IOP in patients on VYZULTA was 26.6 mmHg vs 26.4 mmHg in patients on timolol 0.5%, respectively. APOLLO and LUNAR study designs: Two 12-month and 6-month respectively, Phase 3, randomized, multicenter, double-masked, parallel-group studies evaluating noninferiority of once-daily VYZULTA vs twice-daily timolol maleate 0.5% in patients with open-angle glaucoma or ocular hypertension. Primary endpoint was IOP measured at 9 assessment time points in study eye.1-3

0.6% of patients in VYZULTA clinical trials discontinued therapy due to ocular adverse events (AEs), including ocular hyperemia, conjunctival irritation, eye irritation, eye pain, conjunctival edema, vision blurred, punctate keratitis, and foreign body sensation. Pooled results from the APOLLO and LUNAR studies of ocular adverse events occurring in ≥2% of study eyes: conjunctival hyperemia (5.9%), eye irritation (4.6%), eye pain (3.6%), ocular hyperemia (2.0%), and instillation site pain (2.0%).4

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%)
1. VYZULTA Prescribing Information. 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. Weinreb RN, Liebmann JM, Martin KR, et al. 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.

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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