Perspective

New drug application for Brilliant Blue G solution accepted

The FDA has accepted an orphan new drug application for Brilliant Blue G ophthalmic solution for staining the internal limiting membrane, Dutch Ophthalmic Research Center announced in a press release.

If approved, Brilliant Blue G, intended to stain and distinguish the ILM from the retina to facilitate removal, will be the first FDA-approved product for this indication, the release said.

“DORC has always worked closely with surgeons around the world to develop practical advancements in treating eye disorders” Thierry Leclercq, CEO of DORC International, said in the release. “The Brilliant Blue G ophthalmic solution submission is just another example of DORC responding to market needs. We look forward to working with the FDA throughout the review process.”

The FDA has accepted an orphan new drug application for Brilliant Blue G ophthalmic solution for staining the internal limiting membrane, Dutch Ophthalmic Research Center announced in a press release.

If approved, Brilliant Blue G, intended to stain and distinguish the ILM from the retina to facilitate removal, will be the first FDA-approved product for this indication, the release said.

“DORC has always worked closely with surgeons around the world to develop practical advancements in treating eye disorders” Thierry Leclercq, CEO of DORC International, said in the release. “The Brilliant Blue G ophthalmic solution submission is just another example of DORC responding to market needs. We look forward to working with the FDA throughout the review process.”

    Perspective
    Gilad Rabina

    Gilad Rabina

    Brilliant Blue G (BBG) ophthalmic solution for internal limiting membrane (ILM) staining has been in use in Europe for the past decade. However, no commercial formulation has been approved by the FDA, and off-label indocyanine green (ICG) is a commonly used dye for staining ILM in the United States. Several studies have shown improved visual outcomes with BBG compared with ICG. Some clinical and laboratory studies have suggested the possibility of retinal toxicity with ICG use, such as vacuolization in the inner retinal cells or apoptotic cell death in the inner/outer nuclear layers and retinal pigment epithelial layer, although this is not definitive.

    BBG has a high affinity to the ILM and a low affinity to the epiretinal membrane (ERM). Therefore, BBG also works as a negative stain for ERM. Unlike ICG, BBG utilizes polyethylene glycol as an integrated carrier so the dye falls onto the macula in a fluid-filled eye to avoid the need for an air-fluid exchange or mixture with a dextrose solution (use of ICG dye in dextrose 5% in water can assist in avoiding the use of an air-fluid exchange). BBG staining can also increase ILM rigidity, which can aid in ILM peeling.

    The FDA recently accepted an orphan new drug application for BBG ophthalmic solution for ILM staining. BBG ophthalmic solution may enable ILM peeling in a safer and easier manner and potentially result in better outcomes for our patients.

    The following also contributed to this perspective:

    Ismael Chehaibou, MD, Retina Division, Doheny and Stein Eye Institutes, David Geffen School of Medicine at UCLA

    Niranjan Manoharan, MD, Retina Division, Doheny and Stein Eye Institutes, David Geffen School of Medicine at UCLA

    Michael S. Ip, MD, Doheny Eye Institute, University of California, Los Angeles

     

    References:

    Azuma K, et al. Retina. 2016;doi:10.1097/IAE.0000000000000968.

    Kanda S, et al. Arch Ophthalmol. 2004;doi:10.1001/archopht.122.10.1447.

    Schechter RJ. Am J Ophthalmol. 2002;doi:10.1016/s0002-9394(02)01467-8.

    Arevalo JF, et al. Graefe’s Arch Clin Exp Ophthalmol. 2007;doi:10.1007/s00417-006-0430-3.

    Rodrigues EB, et al. Surv Ophthalmol. 2009;doi:10.1016/j.survophthal.2009.04.011.
    • Gilad Rabina, MD
    • Retina Division, Doheny and Stein Eye Institutes, David Geffen School of Medicine at UCLA
      Division of Ophthalmology, Tel Aviv Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Israel

    Disclosures: Ip reports he is a consultant for Omeros, ThromboGenics, Boehringer Ingelheim, Genentech, Allergan, Regenxbio and Novartis. Rabina, Chehaibou and Manoharan report no relevant financial disclosures.