HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights subjects who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among these subjects when grouped by sex, race, and age. The efficacy of this drug was studied in animal models while the safety was studied in healthy human volunteers. 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 TISSUEBLUE Prescribing Information for complete information.
TISSUEBLUE (Brilliant Blue G Ophthalmic Solution)
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.
What are the benefits of this drug (results of trials used to assess efficacy)?
Adapted from FDA Review
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.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Analyses not conducted because the ages, gender and race were not always reported in the literature articles which supported the approval.
What are the possible side effects?
Side effects during the surgery when TISSUEBLUE is used included retinal tears, bleeding and detachment, and cataracts.
What are the possible side effects (results of trials used to assess safety)?
TISSUEBLUE Prescribing Information
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.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Analyses not conducted.
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.
Data for TISSUEBLUE approval were collected from literature reports and postmarketing safety data reporting in Europe, Asia and South America, with inconsistent demographics reporting.
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.
How were the trials designed?
There were no new trials conducted to establish the efficacy and safety of TISSUEBLUE for the intraoperative staining of the Internal Limiting Membrane (ILM).
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.