A new DRUG TRIALS SNAPSHOT is now available.
TISSUEBLUE is a drug for staining the internal limiting membrane (ILM).
ILM is a transparent membrane inside the eye that sometimes contributes to impaired vision. Surgical removal of the ILM may be needed to improve vision.
TISSUEBLUE is injected into the eye ball by a healthcare provider during a surgical procedure. .
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
Drug Trials Snapshots: TISSUEBLUE
TISSUEBLUE (Brilliant Blue G Ophthalmic Solution)
Dutch Ophthalmic, USA
Approval date: December 20, 2019
Dutch Ophthalmic, USA
Approval date: December 20, 2019
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
TISSUEBLUE is a drug for staining the internal limiting membrane (ILM).
ILM is a transparent membrane inside the eye that sometimes contributes to impaired vision. Surgical removal of the ILM may be needed to improve vision.
How is this drug used?
TISSUEBLUE is injected into the eyeball by a healthcare provider during a surgical procedure.
What are the benefits of this drug?
TISSUEBLUE stains ILM. Staining allows the otherwise transparent ILM to be seen and removed.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
The efficacy of TISSUEBLUE has been established on the data from the literature, so the differences in how well the drug worked among patients grouped by sex, race, and age could not be determined.
What are the possible side effects?
Side effects during the surgery when TISSUEBLUE is used included retinal tears, bleeding and detachment, and cataracts.
Were there any differences in side effects among sex, race and age?
The side effects of TISSUEBLUE have been collected from the literature and reports from other countries where it has been used, so the differences in side effects among patients grouped by sex, race, and age could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved TISSUEBLUE based on the reports in the literature and its use in other countries.
How were the trials designed?
The efficacy and the side effects data for TISSUEBLUE approval were collected from the literature reports and current use in other countries. No new trials were conducted for its approval.
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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