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Zeiss Medical Technology gains NMPA approval for ILM-Blue in China
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Key Takeaways
- ILM-Blue, approved by NMPA in China, enhances vitreoretinal surgery by distinguishing the ILM from other retinal layers, reducing retinal damage risk.
- The dye, known as Tissue Blue in the US, is FDA-approved and has been used in over 900,000 surgeries globally.
The approval makes ILM-Blue the first DORC posterior dye product available in China, according to a press release from Zeiss.
(Image Credit: AdobeStock/Egor)
In a press release, Zeiss Medical Technology announced that its product ILM-Blue from Dutch Ophthalmic Research Center (DORC) has received approval from the National Medical Products Administration (NMPA) in China.1 The internal limiting membrane (ILM) dye has been on the market in Europe since 2010 and is the only ILM staining solution approved by the United States Food and Drug Administration (FDA).
ILM-Blue, marketed under the name Tissue Blue in the US, is the first DORC posterior dye product available in China. The dye is used to distinguish the ILM from other, underlying retinal layers during vitreoretinal (VR) surgery, reducing the risk of retinal damage. ILM-Blue from DORC has been used in over 900,000 surgical procedures globally.
"We are delighted to bring ILM-Blue to the Chinese market, where it will provide retina surgeons with a proven, high-quality staining solution to enhance visualisation,” said Jessie Jiang Bo, General Manager of DORC in China, in the press release. “This approval reinforces our dedication to expanding access to innovative ophthalmic solutions that help surgeons to improve patient outcomes."
Pierre Billardon, head of business sectors surgery posterior segment at Zeiss Medical Technology and CEO of DORC International, also commented on the approval. “ZEISS and DORC are committed to supporting surgeons in the China market with the latest innovation and tools that create a higher standard of care and better patient experience. The global success of ILM-Blue underscores the company’s commitment to providing high-quality and effective solutions to the ophthalmic community,” he said.
Carl Zeiss Meditec AG completed the acquisition of DORC in April of 2024, after announcing the agreement in late 2023. The partnership integrated the DORC Eva Nexus VR surgery platform into the existing Zeiss surgical portfolio.2
References
ILM-Blue from DORC Receives NMPA Approval in China; Expanding Global Reach. Press release. Zeiss Medical Technology. Published March 26, 2025. Accessed March 25, 2025.
Hutton D, Hayes H. Carl Zeiss Meditec AG announces completed acquisition of Dutch Ophthalmic Research Center. Ophthalmology Times Europe. Published April 4, 2024. Accessed March 26, 2025. https://europe.ophthalmologytimes.com/view/carl-zeiss-meditec-ag-announces-completed-acquisition-of-dutch-ophthalmic-research-center
