DORC has announced that it has received notification from the FDA that their new drug application (NDA) for Brilliant Blue G ophthalmic solution has been accepted for review.
The proposed indication for Brilliant Blue G (BBG) ophthalmic solution is to selectively stain the internal limiting membrane (ILM) which forms the inner layer of the retina. Cellular proliferation on the ILM can lead to the formation of vision-impairing epiretinal membranes (ERM) and macular holes. While the removal of the ILM can relieve symptomatic macular distortion caused by ERMs and macular holes, the transparent nature of the ILM makes it difficult to visualize and peel. Brilliant Blue G ophthalmic solution is intended to be injected onto the inner retinal surface, enabling the ILM to be clearly stained and distinguished from unstained retina, thereby facilitating removal. If approved, Brilliant Blue G ophthalmic solution will be the first FDA approved product for this orphan indication.
“I suspect that Brilliant Blue G’s track record for tissue visualisation is why 65% of international retina surgeon respondents of the 2017 ASRS Annual PAT Survey reported that Brilliant Blue G was their preferred ERM/ILM peeling adjuvant,” John S. Pollack, MD, a partner with Illinois Retina Associates in Chicago, said in a company news release. “The availability of an FDA-approved formulation of Brilliant Blue G in a prefilled syringe has been long awaited by U.S. retina specialists, including myself. 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.”
“DORC has always worked closely with surgeons around the world to develop practical advancements in treating eye disorders” Thierry Leclercq, CEO DORC International, said in the news 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.”
Orphan-drug designation is granted by the FDA Office of Orphan Products Development to promote the development of new therapies for rare diseases and disorders affecting fewer than 200,000 individuals in the United States.