FDA Accepts DORC’s Orphan-Drug Designation Application for Trypan Blue and Brilliant Blue G
DORC has has received notification from the FDA that their application for orphan drug designation for a dual combination of Trypan Blue and Brilliant Blue G ophthalmic solutions has been granted.
DORC's MembraneBlue-Dual ILM and ERM stain has been used in more than 500,000 surgeries since launch outside of the US [2]. In April 2020, DORC launched TissueBlue, an FDA-approved selective stain, and since then it has been used in more than 100,000 surgeries and is preferred by over 40% of US retina surgeons [3].
The proposed indication for the combination ophthalmic solution of 0.15% Trypan Blue and 0.025% Brilliant Blue G (BBG) is to selectively stain the epiretinal membrane (ERM) and internal limiting membrane (ILM). The removal of the ERM and ILM can relieve symptomatic macular distortion caused by the membranes and macular holes. The combination Trypan Blue and Brilliant Blue G Ophthalmic Solution is intended to be injected onto the retinal surface, enabling both the ERM and ILM to be clearly stained and distinguished from unstained retina, thereby facilitating removal.
If approved, this combination Trypan Blue and Brilliant Blue G Ophthalmic Solution will be the first FDA approved product for this orphan indication.
"I am very excited about the possibility of having an effective option to stain both internal limiting membrane and epiretinal membrane. Incorporation of TissueBlue into my surgical practice has given me a predictable, safe, and effective stain that I prefer for ILM peeling," Paul Hahn, MD, a retinal specialist with NJ Retina, said in a company news release. "Currently, effective staining options for epiretinal membranes are missing from our toolbox, at least here in the US. I look forward to being able to use a combined ILM-ERM stain to be able to effectively visualize and peel all types of membranes."
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.
References
1 Marketscope – 2023 Retinal Surgical Device Market Report 2 Data on file – DORC Internal Sales Data
3 2022 PAT survey of 893 surgeons in the US and Globally