RHOPRESSA is a drug for reducing elevated intraocular pressure, when the pressure inside the eye is too high.
One drop of RHOPRESSA is applied in the affected eye once daily in the evening.
Drug Trials Snapshots: RHOPRESSA
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.
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 RHOPRESSA Package Insert for complete information.
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 RHOPRESSA Package Insert for complete information.
RHOPRESSA (netarsudil)
‘ro-pre-ssa’
Aerie Pharmaceuticals
Approval date: December 18, 2017
‘ro-pre-ssa’
Aerie Pharmaceuticals
Approval date: December 18, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
RHOPRESSA is a drug for reducing elevated intraocular pressure, when the pressure inside the eye is too high.
How is this drug used?
One drop of RHOPRESSA is applied in the affected eye once daily in the evening.
What are the benefits of this drug?
RHOPRESSA lowers the intraocular pressure.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: RHOPRESSA worked similarly in men and women.
- Race: RHOPRESSA worked similarly in White patients and non-White patients (all other races combined).
- Age: RHOPRESSA worked similarly in patients above and below 65 years of age.
What are the possible side effects?
The most common side effects are conjunctival (eye) redness, golden brown deposits in the cornea (covering of the colored portion of the eye), pain with drug application, conjunctival (eye) bleeding, blurred or decreased vision, increased tearing and redness of the eyelid.
Were there any differences in side effects among sex, race and age?
- Sex: The risk of side effects was similar in men and women.
- Race: The risk of side effects was similar in White and Black or African American patients. The number of patients in other races was limited, therefore differences in side effects among other races could not be determined.
- Age: The risk of side effects was similar in patients above and below 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved RHOPRESSA based on evidence from three clinical trials (NCT # 02207491, NCT# 02207621 and NCT# 02558374) that enrolled 1875 patients with open-angle glaucoma or elevated intraocular pressure. These trials were conducted in the United States.
Figures 1, 2 and 3 summarize patient characteristics in the three clinical trials by sex, race and age.
Figure 1. Baseline Demographics by Sex
Clinical Trial Data
Figure 2. Baseline Demographics by Race
Clinical Trial Data
Table 1. Baseline Demography by Race
| Race | N of Patients | Percentage |
|---|---|---|
| White | 1364 | 73 |
| Black or African American | 467 | 25 |
| Asian | 33 | 2 |
| Other | 11 | less than 1 |
Clinical Trial Data
Figure 3. Baseline Demographics by Age
Clinical Trial Data
How were the trials designed?
Three trials evaluated the benefits and side effects of RHOPRESSA. In each trial, patients were randomly assigned to receive either RHOPRESSA or timolol eye drops (timolol is FDA approved for the treatment of increased intraocular pressure) every day for 3 months. Neither the trial patients nor the health care providers knew which treatment was being given until after the trials were completed. The benefit of RHOPRESSA was measured by decrease in intraocular pressure in comparison to timolol after 2 weeks, 6 weeks and 3 months of treatment.
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.
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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