Trypan Blue

VisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. VisionBlue® 0.06% is a diagnostic dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

VisionBlue® (trypan blue ophtalmic solution) 0.06% is a clear, dark blue ophtalmic solution supplied in 2.25 mL single-patient-use syringe filled to a volume of 0.5 mL. VisionBlue® (trypan blue ophthalmic solution) 0.06% in a single-patient-use syringe.

VisionBlue® 0.06% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it. Insertion of a non-hydrated (dry-state), hydrophilic acrylic intraocular lens (IOL).

Excessive staining : It is recommended that after injection all excess VisionBlue® 0.06% is immediately removed from the eye by thorough irrigation of the anterior chamber. Excessive staining : Excess VisionBlue® 0.06% should be removed from the eye immediately after staining.

Adverse reactions reported following use of VisionBlue® 0.06% include discoloration of high water content hydrogen intraocular lenses ( see Contraindications ) and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week. Inadvertent staining of the posterior lens capsule and vitreous face. To report SUSPECTED ADVERSE REACTIONS contact, Dutch Ophtalmic, 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 VisionBlue® 0.06% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of VisionBlue® 0.06% in humans is expected to be negligible following injection and subsequent removal of the drug at the completion of surgical procedures. Adequate animal reproduction studies were not conducted with VisionBlue® 0.06%, however, trypan blue has been shown to be teratogenic in various animal models at doses 800-fold and greater than the maximum recommended human dose, based on body surface area (BSA). Due to the negligible human systemic exposure when used as recommended, it is not expected that maternal use of VisionBlue® 0.06% will result in fetal exposure to the drug and risk of teratogenic effects. Animal Data Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. Normalized to BSA, these doses are approximately 1,600- and 800-fold the maximum recommended human dose of 0.3 mg per injection (based on a 60 kg person), assuming complete systemic absorption of trypan blue. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 3,200-fold the maximum recommended human dose based on BSA, assuming total absorption). Lactation Risk Summary The presence of trypan blue in human milk following intraocular administration of trypan blue has not been evaluated. There are no data available regarding the effects of trypan blue on milk production. Breastfeeding is not expected to result in exposure of the child to trypan blue due to the negligible systemic exposure of trypan blue in humans following injection and subsequent removal of the drug at the completion of surgical procedures. Pediatric use The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients. Geriatric use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

VisionBlue® 0.06% selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens. VisionBlue® 0.06% is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.