sábado, 18 de noviembre de 2017

VYZULTA: New Drug Trials Snapshot Posted



A new  DRUG TRIALS SNAPSHOT is now available. 
VYZULTA is a drug for reducing elevated intraocular pressure (IOP) when the pressure inside the eye is too high.
One drop of VYZULTA is applied once daily, in the evening, in the affected eye.
See more  Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.

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.

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.

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.

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.

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
RaceNumber of ParticipantsPercentage
White62374%
Black or African American20424%
Asian81%
All Other3less 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

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.

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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