{"id":"brilliant-blue-g","rwe":[],"_fda":{"id":"348abd8b-75b4-7894-e063-6294a90aef28","set_id":"9d4b28b4-c582-4e2c-abd9-f7e203378e2d","openfda":{"nui":["N0000194020","N0000175533"],"unii":["M1ZRX790SI"],"route":["INTRAOCULAR","OPHTHALMIC"],"spl_id":["348abd8b-75b4-7894-e063-6294a90aef28"],"brand_name":["TISSUEBLUE"],"spl_set_id":["9d4b28b4-c582-4e2c-abd9-f7e203378e2d"],"package_ndc":["68803-722-05"],"product_ndc":["68803-722"],"generic_name":["BRILLIANT BLUE G"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["BRILLIANT BLUE G"],"pharm_class_epc":["Disclosing Agent [EPC]"],"pharm_class_moa":["Dyes [MoA]"],"manufacturer_name":["D.O.R.C. Dutch Ophthalmic Research Center (International) B.V."],"application_number":["NDA209569"],"is_original_packager":[true]},"version":"6","pregnancy":["TissueBlue 0.025% - Pregnancy section Risk Summary There are no available data on the use of TissueBlue 0.025% in pregnant women to inform a drug associated risk. Systemic absorption of TissueBlue 0.025% in humans is expected to be negligible following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures. Due to the negligible systemic exposure, it is not expected that maternal use of TissueBlue 0.025% will result in fetal exposure to the drug. Adequate animal reproduction studies were not conducted with TissueBlue 0.025%."],"description":["TissueBlue 0.025% - Description section TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a sterile solution of BBG (a dye) for intraocular ophthalmic use. Each mL of TissueBlue 0.025% contains BBG 0.25 mg, polyethylene glycol and buffered sodium chloride solution (sodium chloride, dibasic sodium phosphate, monobasic sodium phospage, water for injection). Phosphoric acid and/or sodium hydroxide may also be used for pH adjustment. The pH range of TissueBlue 0.025% Solution is between 7.3 and 7.6. The drug substance BBG has the chemical name Brilliant Blue G, a molecular weight of 854.02 and has the following chemical structure: Molecular formula: C 47 H 48 N 3 NaO 7 S 2 BBG.jpg"],"how_supplied":["TissueBlue 0.025% - How supplied section TissueBlue (Brilliant Blue G Ophthalmic Solution), 0.025% is supplied as 0.5 mL of Brilliant Blue G Ophthalmic Solution, 0.025% in a sterile, single-dose Luer Lok, 2.25 mL glass syringe, with a grey rubber plunger stopper and tip cap with polypropylene plunger rod in a pre-formed polypropylene blister pouch sealed with a Tyvek® lid. NDC 68803-722-05 (One 0.5 mL syringe) NDC 68803-722-25 (Carton of five 0.5 mL syringes)"],"geriatric_use":["TissueBlue 0.025% - Geriatric use section No overall differences in safety or effectiveness were observed between elderly and younger adult patients."],"pediatric_use":["TissueBlue 0.025% - Pediatric use section The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established."],"effective_time":"20250507","adverse_reactions":["TissueBlue 0.025% - Adverse Reactions section Adverse reactions that have been reported in procedures that included the use of Brilliant Blue G Ophthalmic Solution have often been associated with the surgical procedure. These complications include retinal (retinal break, tear, hemorrhage, and detachment) and cataracts. Adverse reactions that have been reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. The complications include retinal (retinal break, tear, hemorrhage, and detachment and cataracts. To report SUSPECTED ADVERSE REACTIONS, contact Dutch Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch"],"contraindications":["TissueBlue 0.025% - Contraindications section None None"],"mechanism_of_action":["TissueBlue 0.025% - Mechanism of action section Brilliant Blue G has been shown to selectively stain the ILM, but not the epiretinal membrane nor the retina, making it easier to visualize the membrane for removal, although the exact mechanism of this selectivity has not been elucidated."],"storage_and_handling":["TissueBlue 0.025% - Storage and Handling section TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F). Protect from light, frost and moisture."],"clinical_pharmacology":["TissueBlue 0.025% - Clinical Pharmacology section TissueBlue 0.025% - Mechanism of action section Brilliant Blue G has been shown to selectively stain the ILM, but not the epiretinal membrane nor the retina, making it easier to visualize the membrane for removal, although the exact mechanism of this selectivity has not been elucidated."],"indications_and_usage":["TissueBlue 0.025% - Indications & Usage Section TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM)."],"warnings_and_cautions":["TissueBlue 0.025% - Warnings and Precautions section Excessive Staining Excess TissueBlue 0.025% should be removed from the eye immediately after staining. Use of the Syringe Make sure the plunger moves smoothly before injecting the solution. Do not use the product if the plunger does not move smoothly to prime the cannula. Excessive staining: Excess TissueBlue 0.025% should be removed from the eye immediately after staining. Use of the syringe: Make sure the plunger moves smoothly before injecting the solution."],"nonclinical_toxicology":["TissueBlue 0.025% - Nonclinical toxicology section TissueBlue 0.025% - Nonclinical toxicology section Studies to evaluate the potential for carcinogenicity or impairment of fertility of TissueBlue 0.025% have not been conducted. Brilliant Blue G was not mutagenic in the Ames assay, the in vitro mouse lymphoma assay, or the in vivo rat micronucleus assay.","TissueBlue 0.025% - Nonclinical toxicology section Studies to evaluate the potential for carcinogenicity or impairment of fertility of TissueBlue 0.025% have not been conducted. Brilliant Blue G was not mutagenic in the Ames assay, the in vitro mouse lymphoma assay, or the in vivo rat micronucleus assay."],"spl_unclassified_section":["Distributed by: Dutch Ophthalmic, USA 10 Continental Drive, Bldg 1 Exeter, NH 03833, USA Phone: 800-75-DUTCH or 603-778-6929 Made in Germany All trademarks are the property of their respective owners."],"dosage_and_administration":["TissueBlue 0.025% - Dosage & Administration Section TissueBlue 0.025% is carefully injected into the Balanced Salt Solution (BSS)-filled vitreous cavity using a blunt cannula attached to the pre-filled syringe, without allowing the cannula to contact the retina or allowing TissueBlue to get under the retina. Sufficient staining is expected within a few seconds. Following staining, all excess dye should be removed from the vitreous cavity. Inject TissueBlue 0.025% directly in a Balanced Salt Solution (BSS)-filled vitreous cavity. Excess TissueBlue should be removed from the vitreous cavity."],"spl_product_data_elements":["TISSUEBLUE Brilliant Blue G SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE WATER POLYETHYLENE GLYCOL 3350 BRILLIANT BLUE G BRILLIANT BLUE G"],"dosage_forms_and_strengths":["TissueBlue 0.025% - Dosage forms & Strengths section TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a clear, bright blue, single-dose ophthalmic solution supplied in 2.25 mL syringes pre-filled to a volume of 0.5 mL. TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL."],"use_in_specific_populations":["TissueBlue 0.025% - Use in specific populations section TissueBlue 0.025% - Pregnancy section Risk Summary There are no available data on the use of TissueBlue 0.025% in pregnant women to inform a drug associated risk. Systemic absorption of TissueBlue 0.025% in humans is expected to be negligible following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures. Due to the negligible systemic exposure, it is not expected that maternal use of TissueBlue 0.025% will result in fetal exposure to the drug. Adequate animal reproduction studies were not conducted with TissueBlue 0.025%. TissueBlue 0.025% - Lactation section Risk Summary No data are available regarding the presence of Brilliant Blue G in human milk after intraocular administration of TissueBlue 0.025%, or the effects on the breastfed infant or the effects on milk production. However, breastfeeding is not expected to result in exposure of the child to Brilliant Blue G due to the expected negligible systemic exposure of BBG in humans following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures. TissueBlue 0.025% - Pediatric use section The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established. TissueBlue 0.025% - Geriatric use section No overall differences in safety or effectiveness were observed between elderly and younger adult patients."],"package_label_principal_display_panel":["Package Label - 0.5 mL TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% Staining Solution for Ophthalmic Surgery Protect from light, frost and moisture. Store at 15°C to 25°C (59°F to 77°F). Sterile. Active ingredients: Brilliant Blue G 0.025% Inactive ingredients: Water for injection, Sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, polyethylene glycol, phosphoric acid and/or sodium hydroxide may also be used for pH adjustment. NDC 68803-722-05 (One 0.5 mL syringe) NDC 68803-722-25 (Carton of five 0.5 mL syringes) carton.jpg"]},"tags":[{"label":"Disclosing Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"P2X purinoceptor 7","category":"target"},{"label":"P2RX7","category":"gene"},{"label":"SNCA","category":"gene"},{"label":"Intraocular","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Staining method","category":"indication"},{"label":"Dutch Ophthalmic","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"commonSideEffects":[{"effect":"retinal break","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"retinal tear","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"retinal hemorrhage","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"retinal detachment","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"cataracts","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3}],"specialPopulations":{"Pregnancy":"There are no available data on the use of TissueBlue 0.025% in pregnant women to inform drug associated risk. Systemic absorption of TissueBlue 0.025% in humans is expected to be negligible following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures. Due to the negligible systemic exposure, it is not expected that maternal use of TissueBlue 0.025% will result in fetal exposure to the drug. Adequate animal reproduction studies were not conducted with TissueBlue 0.025%.","Geriatric use":"No overall differences in safety or effectiveness were observed between elderly and younger adult patients.","Paediatric use":"The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established."}},"trials":[],"aliases":[],"company":"Dutch Ophthalmic","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BRILLIANT BLUE G","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:04:08.036012+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Brilliant Blue G","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:04:15.781993+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:04:13.491346+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BRILLIANT BLUE G","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:04:14.262581+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:06.923793+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:06.923830+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:06.923836+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3184128/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:04:15.435438+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"TissueBlue 0.025% - Adverse Reactions section Adverse reactions that have been reported in procedures that included the use of Brilliant Blue G Ophthalmic Solution have often been associated with the surgical procedure. These complications include retinal (retinal break, tear, hemorrhage, and detachment) and cataracts. Adverse reactions that have been reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. The complications includ","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:21.777960+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA209569","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:04:06.923840+00:00"}},"allNames":"tissueblue","offLabel":[],"synonyms":["brilliant blue G","tissueblue"],"timeline":[{"date":"2019-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from DUTCH OPHTHALMIC to Dutch Ophthalmic"},{"date":"2019-12-20","type":"positive","source":"DrugCentral","milestone":"FDA approval (Dutch Ophthalmic)"},{"date":"2026-12-20","type":"negative","source":"FDA Orange Book","milestone":"ODE-282 exclusivity expires"}],"brandName":"Tissueblue","ecosystem":[{"indication":"Staining method","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"P2X purinoceptor 7","targets":[{"gene":"P2RX7","source":"DrugCentral","target":"P2X purinoceptor 7","protein":"P2X purinoceptor 7"},{"gene":"SNCA","source":"DrugCentral","target":"Alpha-synuclein","protein":"Alpha-synuclein"}],"moaClass":"Dyes","modality":"Small Molecule","drugClass":"Disclosing Agent [EPC]","explanation":"TissueBlue 0.025% Mechanism of action section. Brilliant Blue has been shown to selectively stain the ILM, but not the epiretinal membrane nor the retina, making it easier to visualize the membrane for removal, although the exact mechanism of this selectivity has not been elucidated.","oneSentence":"Tissueblue works by binding to the P2X purinoceptor 7, a specific receptor on cells, to reveal or stain tissues.","technicalDetail":"Tissueblue exerts its effect by selectively binding to the P2X7 receptor, a subtype of purinergic receptor, which is involved in various cellular processes, including inflammation and cell death.","_target_confidence":0.5},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Coomassie_brilliant_blue","title":"Coomassie brilliant blue","extract":"Coomassie brilliant blue is the name of two similar triphenylmethane dyes that were developed for use in the textile industry but are now commonly used for staining proteins in analytical biochemistry. Coomassie brilliant blue G-250 differs from Coomassie brilliant blue R-250 by the addition of two methyl groups. The name \"Coomassie\" is a registered trademark of Imperial Chemical Industries."},"commercial":{"launchDate":"2019","_launchSource":"DrugCentral (FDA 2019-12-20, DUTCH OPHTHALMIC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5359","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BRILLIANT%20BLUE%20G","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BRILLIANT BLUE G","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Coomassie_brilliant_blue","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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Switzerland","startDate":"2011-11","conditions":["Macular Edema"],"enrollment":50,"completionDate":"2028-06"},{"nctId":"NCT01820520","phase":"PHASE3","title":"Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery","status":"TERMINATED","sponsor":"Asociación para Evitar la Ceguera en México","startDate":"2013-01","conditions":["Macular Hole","Epiretinal Membrane"],"enrollment":22,"completionDate":"2014-02"},{"nctId":"NCT06233500","phase":"NA","title":"Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study","status":"UNKNOWN","sponsor":"Fayoum University","startDate":"2021-12-01","conditions":["Macular Holes"],"enrollment":28,"completionDate":"2024-03-15"},{"nctId":"NCT05086588","phase":"","title":"Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.","status":"COMPLETED","sponsor":"Dr. Lutfi Kirdar Kartal Training and Research 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Analysis.","status":"COMPLETED","sponsor":"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo","startDate":"2018-01-09","conditions":["Macular Holes"],"enrollment":43,"completionDate":"2018-08-23"},{"nctId":"NCT04158791","phase":"","title":"Outcomes Based on the Pre-operative Integrity of IS/OS Junction in Idiopathic Epimacular Membrane Surgery","status":"COMPLETED","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2018-03-25","conditions":["Epimacular Membrane"],"enrollment":18,"completionDate":"2019-07-09"},{"nctId":"NCT04135638","phase":"NA","title":"Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison","status":"UNKNOWN","sponsor":"University of Molise","startDate":"2019-11-01","conditions":["Macular 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Dutch Ophthalmic Research Center (International) B.V.","brandName":"TISSUEBLUE","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2019-","companyName":"Dutch Ophthalmic","relationship":"Original Developer"}],"publicationCount":745,"therapeuticAreas":["Ophthalmology"],"biosimilarFilings":[],"originalDeveloper":"Dutch Ophthalmic","recentPublications":[],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Dutch Ophthalmic","companyId":"dutch-ophthalmic","modality":"Small molecule","firstApprovalDate":"2019","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:04:26.073240+00:00","fieldsConflicting":6,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}