Brilliant Blue G

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.

• & Usage 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).

• None Nonecontraindicated

Dosage & Administration 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.

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.

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

Pregnancy 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%. Lactation 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. Pediatric use The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established. Geriatric use No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

• Dec 20, 2019NDANDA209569Dutch Ophthalmic

1. 1Disability3—
2. 2Visual Impairment3—
3. 3Blindness2—
4. 4Non-infectious Endophthalmitis2—
5. 5Adverse Drug Reaction1—
6. 6Drug Hypersensitivity1—
7. 7Endophthalmitis1—
8. 8Eye Disorder1—
9. 9Eye Injury1—
10. 10Hemianopia1—
11. 11Impaired Quality Of Life1—
12. 12Injection Site Discolouration1—
13. 13Macular Hole1—
14. 14Neoplasm Malignant1—
15. 15Nonspecific Reaction1—

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Brilliant Blue G as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)
  Recruiting · Interventional · 20 enrolled · Ain Shams University
  NCT07633457updated 2026-06-08
• Mechanical Properties of the Internal Limiting Membrane and Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy
  Recruiting · Observational · 50 enrolled · University Hospital, Basel, Switzerland
  NCT01485575updated 2025-02-13
• Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
  Terminated · Phase 3 · Interventional · 22 enrolled · Asociación para Evitar la Ceguera en México
  NCT01820520updated 2024-05-30
• Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
  Unknown · Interventional · 28 enrolled · Fayoum University
  NCT06233500updated 2024-01-31
• Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.
  Completed · Observational · 86 enrolled · Dr. Lutfi Kirdar Kartal Training and Research Hospital
  NCT05086588updated 2021-10-21
• Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes
  Completed · Interventional · 30 enrolled · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  NCT03020459updated 2021-05-13
• Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy
  Completed · Observational · 14 enrolled · Centro Oftalmológico Dr Charles
  NCT04490876updated 2020-07-30
• Infracyanine Green vs Brilliant Blue G in Macular Hole Inverted Flap Surgery: A Swept Source OCT Analysis.
  Completed · Interventional · 43 enrolled · Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
  NCT03946267updated 2020-07-15
• Outcomes Based on the Pre-operative Integrity of IS/OS Junction in Idiopathic Epimacular Membrane Surgery
  Completed · Observational · 18 enrolled · Fondazione IRCCS Policlinico San Matteo di Pavia
  NCT04158791updated 2019-11-13
• Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
  Unknown · Interventional · 28 enrolled · University of Molise
  NCT04135638updated 2019-10-22

Frequently asked questions

How does Brilliant Blue G work?

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.

What is Brilliant Blue G used for?

According to FDA labeling, Brilliant Blue G carries indications including: & Usage 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Brilliant Blue G?

Brilliant Blue G is classified as Disclosing Agent, Dyes.

What are the contraindications for Brilliant Blue G?

Brilliant Blue G labeling lists contraindications including: None None. Always consult the full prescribing information and a clinician.