DORC Announces Health Canada Approval of Tissueblue for Staining of the ILM During Vitreoretinal Surgery

DORC has announced that it has received notification from Health Canada that the application for Tissueblue (Brilliant Blue G Ophthalmic Solution 0.025%) has been approved and will be available  later in 2021 via Innovamed, DORC’s local distributor partner. Tissueblue is the first dye approved by Health Canada for use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane (ILM). 

The Canadian approvals comes a year after Tissueblue received FDA approval. Since FDA approval, DORC estimates Tissueblue has been used in over 15,000 retina procedures in the US[1].

According to DORC:

• 96% of users would recommend Tissueblue to their colleagues–confirmed in evaluation surveys completed by 49 US retina surgeons following use of their first sample of Tissueblue[2]
• The formulation of Tissueblue will be the first ILM stain available in Canada to feature pharmaceutical grade dye material
• Tissueblue will also be the first ILM stain available in Canada in a sterile, prefilled syringe for improved ease of use–44/49 surgeons rated this feature as ‘Excellent’ in the US surgeon evaluations[2]
• Tissueblue will provide a safe and effective replacement to ICG and other compounded or off- label staining agents previously used in Canada[3]
• DORC expects to start shipping Tissueblue to customers in late 2021 after finalizing technical product filing requirements for Health Canada
• Tissueblue will be distributed by DORC’s local partner, Innovamed, which already distributes the DORC EVA phacovitrectomy system, instruments and VisionBlue, the only cataract stain approved in Canada

“Health Canada approval of Tissueblue is an important milestone for retina surgeons in Canada,” David Chow, MD, Assistant Professor St Michael’s Hospital, said in a company news release. “Retina specialists will welcome the opportunity to use an approved ILM dye that combines consistent, high quality staining performance with a long track-record of safe use worldwide in over 350,000 surgeries since launch. A further benefit is the convenience and added security of its packaging in a sterile, prefilled syringe, avoiding the need for mixing the dye prior to use. I am excited to have the opportunity to use this stain in my macular surgery.”

“Following one year from FDA approval, we are delighted to bring Tissueblue to Canadian retina surgeons,” Pierre Billardon, CEO DORC International, said in the news release. “Experience from 15,000 surgical procedures and feedback from users of TissueBlue confirms the surgical benefits of TissueBlue and also highlights that surgeons prefer operating with a pharmaceutical grade, approved dye. This approval is the result of several years of intensive work from cross functional teams within DORC and we are also very grateful for the support we have received from the Canadian Retina Society and retina surgeons in the US.”

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 Injection is applied onto the inner retinal surface, enabling the ILM to be clearly stained and distinguished from unstained retina, thereby facilitating removal.

1.DORC US Sales of TissueBlue and Global Sales data for ILM Blue – available on file

2. Results of 49 surgeon evaluations collected from US retina surgeons sampling TissueBlue – available on file

3. PAT Survey 2017 – ‘What adjuvant do you prefer as an aid in ERM and/or ILM peeling?’ 2017 PAT survey of 1077 surgeons in the US and Globally