FDA approves capsular dye to assist cataract surgery

March 1, 2005

Surgeons who have resorted to using off-label dyes to stain the anterior lens capsule during cataract surgery have a new ophthalmic solution designed to facilitate removal of very mature cataracts.

More than 5 years after U.S. surgeons got their first glimpse of trypan blue ophthalmic solution (Vision Blue, Dutch Ophthalmic Research Center [DORC], The Netherlands) at an Orlando trade show, the FDA has approved the solution.

In the absence of red fundus reflex, the solution is injected via ready-to-use syringes into the anterior lens capsule. The dye provides a clear outline of the capsulorhexis rim, making it easy for surgeons to detect white cataracts and make a clean cut.

The company sold the solution in the United States until the end of that year, but DORC decided to withdraw it from the market while FDA officials debated whether it should be classified as a device or a drug, she said.

The product is sold as a device in 60 countries, including Canada and throughout Europe and South America, and the company was unfamiliar with the drug application process. DORC designs and manufactures a range of phacoemulsification and vitreoretinal instruments.

The American Society of Cataract and Refractive Surgery (ASCRS) helped to set up meetings with senators and lobby on DORC's behalf. In 2003, the company submitted a new drug application and worked with the FDA to win approval, which was issued Dec. 16. The company began U.S. distribution Jan. 10.

ASCRS President Priscilla Arnold, MD, said the solution will increase patient safety by reducing complications.

"ASCRS has been advocating for its approval for several years and has been working with DORC, the manufacturer of the dye, to expedite this process," she said.

The company has sold more than 700,000 units worldwide since 1999.

The FDA said it required the product to be classified as a drug because of the way it interacts with tissues.

"The product is a drug because it is a dye that selectively stains some tissues, but not other tissues," said Crystal Rice, public affairs specialist for the FDA's Center for Drug Evaluation and Research. "In order to stain selectively, there must be a chemical interaction [that] differentiates those tissues that are stained [from] those which are not. The chemical interaction makes it a drug."

Before its approval, Carleton said, surgeons either asked compounding pharmacies to mix the dye per patient or relied on indocyanine green (ICG) dye (Akorn Inc., Buffalo Grove, IL). Surgeons also used fluorescein dye, although neither that nor ICG is approved for this indication, Rice observed.

David F. Chang, MD, clinical professor, University of California, San Francisco, said in a DORC news release that Vision Blue offers advantages over ICG in that "it is FDA approved, does not require mixing, and provides superior and more prolonged capsular visualization."