The Dutch Ophthalmic Research Center (DORC) International BV has received Orphan Drug designation (ODD) from the FDA for its dual-combo Trypan Blue (TB) and Brilliant Blue G (BBG) ophthalmic solutions.
Refresh me on ODD.
Orphan drug designation (ODD) is given to certain orphan drugs that show promise for treating, preventing, or diagnosing orphan diseases (rare serious or life-threatening diseases or conditions that affect >200,000 patients in the United States).
Drugs in this category go through the same scientific review process as any other drug seeking approval for licensing.
Through ODD, a drug qualifies for:
- Tax credits for qualified clinical trials
- Exemption from user fees
- Potential 7 years of market exclusivity following approval
Now DORC.
Founded in 1983 and based in the Netherlands, DORC exports instruments and equipment designed for anterior and posterior ophthalmic surgery to over 80 countries.
The company also has sales and marketing organizations in nine countries, including the United States, United Kingdom, and France.
Let’s start with Trypan Blue.
Trypan Blue ophthalmic solution (VisionBlue) (0.06%) was FDA approved in 2004 as an aid to stain the anterior capsule of the lens to visualize the capsulorhexis in cataract surgery.
The formulation consists of a highly-purified TB with the “lowest recorded levels of mono-azo dye,” according to DORC, which can reduce the risk for toxic anterior segment syndrome (TASS).
Now the BBG formulation.
DORC’s BBG ophthalmic solution (0.025%) (ILM Blue outside the US / TissueBlue in the U.S.) was approved by the FDA in 2019 for use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane (ILM).
The 0.025% concentration can enable retinal surgeons to see the fundus during staining and removal of the dye solution
And this new combo?
Per DORC, this latest proposed concentration includes 0.15% Trypan Blue and 0.025% BBG.
The combo is intended to selectively stain an epiretinal membrane (ERM) and ILM; the removal of the ERM and ILM might assist in the reduction of symptomatic macular distortion caused by the membranes and macular holes.
How is this done?
Both solutions are designed to be injected onto the retinal surface, allowing for both the ERM and ILM to be clearly stained and separate from the unstained retina (facilitating the removal).
Significance?
According to DORC, if this combo’s ODD is approved, it would become the first approved product for such an indication in the United States.
What other major products does DORC offer?
Back in April 2020, the company launched its FDA-approved TissueBlue (BBG ophthalmic solution) 0.025% —currently the only FDA-approved selective stain for ILM.
The product is available as a pre-filled, sterile syringe and has been used in 350,00+ procedures across the globe (where it’s marketed as “ILM Blue”).
See here for a complete product list.