Drugs

Drug Trials Snapshots: Vyzulta

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VYZULTA Prescribing Information for complete information.

VYZULTA (latanoprostene bunod)
(vye-ZUL-tuh)
Bausch & Lomb Inc.
Approval date: November 2, 2017


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

VYZULTA is a drug for reducing elevated intraocular pressure (IOP) when the pressure inside the eye is too high.

How is this drug used?

One drop of VYZULTA is applied once daily, in the evening, in the affected eye.

What are the benefits of this drug?

VYZULTA lowers the intraocular pressure.

What are the benefits of this drug (results of trials used to assess efficacy)?

VYZULTA lowered IOP up to 7 to 9 mmHg in patients with open-angle glaucoma or ocular hypertension who started with average baseline intraocular pressures (IOPs) of 26.7 mmHg.

VZYLTA Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: VYZULTA worked similarly in men and women.
  • Race: VYZULTA worked similarly in White and Black or African American participants. The number of participants in other races was limited, therefore differences in response could not be determined.
  • Age: VYZULTA worked similarly in participants above and below age 65.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

Subgroup differences for the mean IOP (ITT population) at Month 3 for Trials 1 and 2 are presented in the figures below.

Figure 4. Subgroup Analysis for the Mean IOP-Trial 1

(Alt-Tag: Table summarizes efficacy results by subgroup).

Adapted from FDA Statistical review

 

Figure 5.  Subgroup Analysis for the Mean IOP-Trial 2

(Alt-Tag: Table summarizes efficacy results by subgroup).

Adapted from FDA Statistical review

What are the possible side effects?

The most common side effects are conjunctival (eye) redness, eye irritation and eye discomfort (pain).

VYZULTA may cause the iris (colored part of the eye) to become darker in color.

What are the possible side effects (results of trials used to assess safety)?

Below is the summary of the most common ocular adverse reactions observed in participants treated with VYZULTA. The results are based on safety population (N=811) that was comprised of all VYZULTA exposed participants from the efficacy phase and an open extension phase of the trials.

  • Conjunctival hyperemia (6%)
  • Eye irritation (4%)
  • Eye pain (3%)
  • Instillation site pain (2%).

VZULTA Prescribing Information

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The occurrence of side effects was similar in White and Black or African American participants. The number of participants in other races was limited, therefore differences in side effects among other races could not be determined.
  • Age: The occurrence of side effects was similar in participants above and below age 65.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes common ocular adverse reactions in VZYLTA treated subgroups for Trials 1 and 2 combined. The results are based on safety population (N=811) that was comprised of all VYZULTA exposed participants from the efficacy phase of the trials and an open extension phase of the trials.

Table 6. Summary of Ocular Adverse Reactions in VZYLTA Treated Participants by Subgroup (Safety population)

  VZYLTA
N=811
n/N (%)
Sex
Men 69/338 (20%)
Women 67/473 (14%)
Age (years)
<65 65/387 (17%)
65-75 47/300 (16%)
≥75 24/124 (19%)
Race
White 112/606 (19%)
Black or African American 22/195 (11%)
Asian 2/7 (29%)
Other 0/3 (0%)

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved VYZULTA based on evidence from two clinical trials that enrolled 840 participants with open angle glaucoma or ocular hypertension. The trials were conducted in the United States, United Kingdom, Germany, Italy, Bulgaria, Czech Republic and Japan.

Figure 1 summarizes how many men and women were enrolled in the clinical trials.

Figure 1. Baseline Demographics by Sex

(Alt-Tag: Pie chart summarizing how many men and women were in the clinical trials. In total, 350 men (42%) and  490 women (58%) participated in the clinical trials.)

Clinical Trial Data

Figure 2 summarizes the percentage of participants by race in the clinical trials.

 

Figure 2. Baseline Demographics by Race

 

(Alt-Tag: Pie chart summarizing the percentage of patients by race in the clinical trials. In total, 623 White (74%), 204 Black or African American (24%), 8 Asians (1%), and 3 Other (<1%), participated in the clinical trials

Clinical Trial Data

 Table 1. Baseline Demographics by Race

Race Number of Participants Percentage
White 623 74%
Black or African American 204 24%
Asian 8 1%
All Other 3 less than 1%

Figure 3 summarizes the percentage of participants by age that were enrolled in the clinical trials

Figure 3 Baseline Demographics by Age

Alt-Tag: Pie charts summarizing how many individuals of certain age groups were in the clinical trial. In total, 402 patients  were younger than 65 years (48%), and  438 patients were  65 years and older (52%)

Clinical Trial Data

The table below summarizes demographics of all randomized participants in clinical Trials 1 and 2 combined.

Table 7. Baseline and Demographics (Randomized Population)

  Trial 1 Trial 2 Total
(N=840)
VYZULTA
N=286
Timolol
N=134
VYZULTA
N=283
Timolol
N=137
Sex , n (%)
Men 118 (41) 56 (42) 118 (42) 58 (42) 350 (42)
Women 168 (59) 78 (58) 165 (58) 79 (58) 490 (58)
Age (years)
Median 65 64 65 65 65
Min, Max 22,88 23,83 23,87 37,88 22, 88
Age Group, n (%)
<65 years 139 (49) 68 (51) 131 (46) 64 (47) 402 (48)
≥ 65 years 147 (51) 66 (49) 152 (54) 73 (53) 438 (52)
Race, n (%)
White 219 (77) 109 (81) 208 (74) 89 (65) 623 (74)
Black or African American 64 (22) 24 (18) 70 (25) 46 (34) 204 (24)
Asian 1 (1) 1 (1) 4 (1) 2 (2) 8 (1)
Other 2 (1) 0 (0) 1 (<1) 0 (0) 3 (<1)
Ethnicity, n (%)
Hispanic or Latino 30 (10) 13 (10) 37 (13) 19 (14) 99(12)
Not Hispanic or Latino 256 (90) 121 (90) 246 (87) 118 (86) 741 (88)
Region, n (%)
United States 246 (86) 110 (82) 274 (97) 133 (97) 763 (91)
European Union 40 (14) 24 (18) 9 (3) 4 (3) 77 (9)

Clinical Trial Data

How were the trials designed?

There were two trials that evaluated the benefits and side effects of VYZULTA.

In each trial, participants were randomly assigned to receive either VYZULTA or an approved drug timolol (ophthalmic solution) every day for 3 months. Neither the participants nor the health care providers knew which treatment was being given until after the trials were completed.

The benefit of VYZULTA was measured by decrease in IOP in comparison to timolol after 3 months of treatment.

The side effects were evaluated both during the same three months’ period when the benefits were being evaluated and afterward at which point all the participants (VYZULTA treated and timolol treated) were moved to VYZULTA treatment only for an additional 3 to 9 months. This way, the side effects of VYZULTA could be evaluated in larger number of participants and for longer period.

How were the trials designed?

There were two randomized, multicenter, double-masked, active control trials that evaluated the safety and efficacy of VYZULTA. In each trial, participants were randomized in a 2:1 ratio to receive either VYZULTA or active control timolol ophthalmic solution.

The primary efficacy endpoint was the mean IOP in the study eye measured at the specified time points at Week 2, Week 6, and Month 3.

Both trials had an open-label safety extension period during which all participants received VYZULTA. The safety extension period was nine months in Trial 1 and three months for Trial 2.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

VYZULTA Prescribing Information

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Page Last Updated: 11/20/2017
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