December 16, 2004

The Food and Drug Administration (FDA) today announced the approval of Vision Blue (trypan blue ophthalmic solution). Vision Blue is the first product approved in the United States for staining the anterior lens capsule during cataract surgery.

The use of Vision Blue will enhance the ability of ophthalmologists (eye surgeons) to remove white cataracts, a very advanced mature cataract (typically seen in countries where medical care is not widely available), by allowing the ophthalmologist to see the capsule as it is cut and removed. Clean cuts in the capsule are known to reduce some of the risks associated with the surgical removal of a cataract. Over 1.4 million people have cataract surgery each year in the United States, although only a small portion of these cataracts are mature white cataracts.

A cataract is a clouding of the eye's naturally clear lens. Cataract development is a normal process of aging, but cataracts can also develop from eye injuries, certain diseases, such as diabetes, or medications. The lens focuses light rays on the retina -- the layer of light-sensing cells lining the back of the eye -- to produce a sharp image. When the lens becomes cloudy, light rays cannot pass through it easily, and vision is blurred. Surgery is the only way to remove a cataract. Selective staining of the anterior lens capsule with Vision Blue makes it easier to visualize, manipulate, and remove the cloudy lens through a surgical incision.

The safety and effectiveness of Vision Blue has been established in pediatric patients. No overall differences in safety and effectiveness have been observed between elderly and younger patients.

The adverse reactions from the use of Vision Blue are generally self-limited and of short duration. They include discoloration of intraocular lenses and staining of the posterior lens capsule and the vitreous.

Vision Blue is currently marketed in 30 countries. D.O.R.C. International of the Netherlands is the manufacturer.