In Phase 3 trials, VYZULTA had a low incidence of hyperemia1
Ocular AEs Occurring in ≥2% of Study Eyes (Safety Population)2
- Adverse event*
- VYZULTA (n=811)Mean 231.9 days of treatment
- timolol 0.5% (n=271)Mean 90.4 days of treatment
-
- Conjunctival hyperemia
- Eye irritation
- Eye pain
- Ocular hyperemia
- Instillation site pain
-
- 5.9%
- 4.6%
- 3.6%
- 2.0%
- 2.0%
-
- 1.1%
- 2.6%
- 2.2%
- 0.7%
- 1.8%
- Adverse event*
- VYZULTA (n=811)Mean 231.9 days of treatment
-
- Conjunctival hyperemia
- Eye irritation
- Eye pain
- Ocular hyperemia
- Instillation site pain
-
- 5.9%
- 4.6%
- 3.6%
- 2.0%
- 2.0%
- Adverse event*
- timolol 0.5% (n=271)Mean 90.4 days of treatment
-
- Conjunctival hyperemia
- Eye irritation
- Eye pain
- Ocular hyperemia
- Instillation site pain
-
- 1.1%
- 2.6%
- 2.2%
- 0.7%
- 1.8%
No incidence of corneal verticillata or treatment-related conjunctival hemorrhage was observed in pivotal trials.3
<1% discontinuation
0.6% of patients discontinued due to any ocular AE.1
Longer duration of therapy
The incidence of AEs for VYZULTA represents 2.5 times longer duration of therapy than with timolol 0.5%.2
For patients who received timolol 0.5% during the first 3 months of APOLLO/LUNAR and crossed over to VYZULTA in the open-label extension phase, AEs reported after the first dose of VYZULTA are presented in association with VYZULTA.2
See why a low incidence of hyperemia, particularly with monotherapy, is key to patient adherence.4,5
*Pooled results from the APOLLO and LUNAR studies.
In Phase 3 trials, VYZULTA had a low incidence of hyperemia1
Ocular AEs Occurring in ≥2% of Study Eyes (Safety Population)2
- Adverse event*
- VYZULTA (n=811)Mean 231.9 days of treatment
- timolol 0.5% (n=271)Mean 90.4 days of treatment
-
- Conjunctival hyperemia
- Eye irritation
- Eye pain
- Ocular hyperemia
- Instillation site pain
-
- 5.9%
- 4.6%
- 3.6%
- 2.0%
- 2.0%
-
- 1.1%
- 2.6%
- 2.2%
- 0.7%
- 1.8%
- Adverse event*
- VYZULTA (n=811)Mean 231.9 days of treatment
-
- Conjunctival hyperemia
- Eye irritation
- Eye pain
- Ocular hyperemia
- Instillation site pain
-
- 5.9%
- 4.6%
- 3.6%
- 2.0%
- 2.0%
- Adverse event*
- timolol 0.5% (n=271)Mean 90.4 days of treatment
-
- Conjunctival hyperemia
- Eye irritation
- Eye pain
- Ocular hyperemia
- Instillation site pain
-
- 1.1%
- 2.6%
- 2.2%
- 0.7%
- 1.8%
No incidence of corneal verticillata or treatment-related conjunctival hemorrhage was observed in pivotal trials.3
<1% discontinuation
0.6% of patients discontinued due to any ocular AE.1
Longer duration of therapy
The incidence of AEs for VYZULTA represents 2.5 times longer duration of therapy than with timolol 0.5%.2
For patients who received timolol 0.5% during the first 3 months of APOLLO/LUNAR and crossed over to VYZULTA in the open-label extension phase, AEs reported after the first dose of VYZULTA are presented in association with VYZULTA.2
See why a low incidence of hyperemia, particularly with monotherapy, is key to patient adherence.4,5
*Pooled results from the APOLLO and LUNAR studies.
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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%)
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here to see full Prescribing Information.
References: 1. VYZULTA. Prescribing Information. Bausch & Lomb Inc. 2. 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. 3. Data on file. Bausch & Lomb Inc. 4. Zimmerman TJ, Hahn SR, Gelb L, Tan H, Kim E. 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):145-52. 5. 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, 1327.e1-3.
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