VISIONBLUE

Indications & Usage 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.

Dosage & Administration Cataract surgery. VisionBlue® 0.06% is packaged in a single-patient-use syringe filled to a volume of 0.5 mL syringe to which a blunt cannula has to be attached. After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of VisionBlue® 0.06% by the aqueous. VisionBlue® 0.06% is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed. Inject an air bubble into the anterior chamber; Carefully apply VisionBlue® 0.06% onto the lens capsule; Remove all excess dye from the anterior chamber.

Contraindications 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).

Warnings and Precautions 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 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).