Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 3/1/2022
Drug Description

What is TissueBlue and how is it used?

TissueBlue is a prescription medicine used for staining of the Internal Limiting Membrane (ILM). TissueBlue may be used alone or with other medications.

TissueBlue belongs to a class of drugs called Ophthalmic Stains.

It is not known if TissueBlue is safe and effective in children.

What are the possible side effects of TissueBlue?

TissueBlue may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • blindness,
  • blurred vision,
  • decreased vision or other vision changes,
  • seeing "floaters" or light flashes,
  • seeing floating spots before the eyes, and
  • a veil or curtain appearing across any part of your vision

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of TissueBlue include:

  • none

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TissueBlue. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a sterile solution of BBG (a dye). Each mL of TissueBlue 0.025% contains BBG 0.25 mg, Polyethylene Glycol 40mg and Buffered Sodium Chloride solution (8.20 mg of sodium chloride, 3.10 mg sodium phosphate dibasic dodecahydrate, 0.30 mg sodium phosphate monobasic dihydrate, water for injection). 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:

TissueBlue Structural Formula - Illustration

Molecular formula: C47H48N3NaO7S2.

Indications & Dosage


TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is indicated to selectively stain the internal limiting membrane (ILM).


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.


Dosage Forms And Strengths

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.

Storage And Handling

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)

TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F). Protect from light, frost and moisture.

Dutch Ophthalmic, USA, 10 Continental Drive, Bldg 1 Exeter, NH 03833, USA  Revised: Dec 2019


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Side Effects & Drug Interactions


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.


No Information provided

Warnings & Precautions


Included as part of the 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.

Use In Specific Populations


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%.


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.

Overdosage & Contraindications


No information provided.



Clinical Pharmacology


Mechanism Of Action

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.

Medication Guide


No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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