FDA OKs Ophthalmic Stain for Vitreoretinal Surgery

Megan Brooks


December 26, 2019

The US Food and Drug Administration (FDA) has approved Brilliant Blue G ophthalmic solution 0.025% (Dutch Ophthalmic Research Center [DORC]) for staining of the internal limiting membrane during vitreoretinal surgery.

The internal limiting membrane (ILM) forms the inner layer of the retina. Cellular proliferation on the ILM can lead to the formation of vision-impairing epiretinal membranes (ERMs) and macular holes.

Removing the ILM can relieve symptomatic macular distortion caused by ERMs and macular holes, but the transparent nature of the ILM makes it difficult to visualize and peel, the company explains in a news release.

By injecting Brilliant Blue G ophthalmic solution onto the inner retinal surface, the ILM can be clearly stained and distinguished from unstained retina, thereby facilitating removal.

"The availability of an FDA-approved formulation of Brilliant Blue G in a prefilled syringe has been long awaited by US retina specialists, including myself," John Pollack, MD, a partner with Illinois Retina Associates in Chicago, said in the news release.

"The fact that this formulation includes polyethylene glycol as a carrier for improved targeting of the stain is icing on the cake. I look forward to having access to this important tool," said Pollack.

The FDA previously granted Brilliant Blue G orphan-drug designation, a regulatory pathway designed to promote the development of new therapies for rare diseases and disorders affecting fewer than 200,000 individuals in the United States.

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