Dutch Ophthalmic Research Centre (DORC) announced it has received FDA approval for TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025%.
TissueBlue is the first FDA-approved dye for use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane (ILM), according to DORC. The transparent nature of the ILM makes it difficult to visualize and peel. TissueBlue is injected onto the inner retinal surface, enabling the ILM to be clearly stained and distinguished from unstained retina, thereby facilitating removal.
Further highlights of TissueBlue include:
TissueBlue (branded as ILM Blue in other markets outside the USA) has been used for over 350,000 surgical procedures since launch
The formulation of TissueBlue is unique in the United States, and features pharmaceutical grade dye material – ensuring a higher level of purity than lower-grade (compounded) dyes
TissueBlue contains Polyethylene Glycol to provide the density required by surgeons to ensure targeted application to the retina
TissueBlue will be available in a terminally sterilized, prefilled syringe for improved convenience, consistent formulation and ensuring sterile delivery of the dye
TissueBlue will provide a safe and effective replacement to the compounded or off-label staining agents previously used in the USA
DORC expects to start shipping TissueBlue to customers in early April after finalizing the product labelling, shipping and storage in the USA.
“DORC is delighted to announce the approval of TissueBlue, a landmark product approval for the US surgical retina market,” Thierry Leclercq, CEO DORC International, said in a company news release. “This approval is the result of several years of intensive work from cross functional teams within DORC and has also involved close collaboration with the US retina community. We are delighted to be meeting this unmet need of US retina surgeons”
TissueBlue is used 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 injected onto the inner retinal surface, enabling the ILM to be clearly stained and distinguished from unstained retina, thereby facilitating removal.
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.