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.
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.
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
Clinical Trial Data
Figure 2 summarizes the percentage of participants by race in the clinical trials.
Figure 2. Baseline Demographics by Race
Clinical Trial Data
Table 1. Baseline Demographics by Race
Number of Participants
Black or African American
less than 1%
Figure 3 summarizes the percentage of participants by age that were enrolled in the clinical trials
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.
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.
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