FDA approves trypan blue 0.15%

April 1, 2009

The FDA has approved trypan blue ophthalmic solution 0.15% (MembraneBlue, Dutch Ophthalmic Research Center International, b.v.) for use as an aid during vitrectomy procedures by staining the epiretinal membranes and, thereby, facilitating the removal of tissue, according to a prepared statement.

Exeter, NH

―The FDA has approved trypan blue ophthalmic solution 0.15% (MembraneBlue, Dutch Ophthalmic Research Center International, b.v.) for use as an aid during vitrectomy procedures by staining the epiretinal membranes and, thereby, facilitating the removal of tissue, according to a prepared statement.

Available in sterile, single-use, 2.25-ml syringes filled to a volume of 0.5 ml, trypan blue 0.15% is the first and only approved solution for this indication, the company said. It selectively stains epiretinal membranes during ophthalmic surgical vitrectomy procedures and is intended to be applied directly to areas where membranes could be present.

Previously, trypan blue ophthalmic solution 0.06% (VisionBlue) was the only stain approved by the FDA for the anterior capsule of the lens during capsulorhexis. According to the statement, with this new FDA approval, trypan blue 0.15% now provides vitreoretinal surgeons with a higher concentration of a sterile solution of the acid diazo group dye.

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