Innovative Corneal Storage Bring New Hope to Patients with Corneal Blindness
On June 27, the corneal storage solution developed by the team at the Affiliated Eye Hospital of Shandong First Medical University and manufactured by Shandong Biodear Medical Devices Co., Ltd. (“Biodear”) officially received approval from the National Medical Products Administration for market release.
This marks the first corneal storage product in China with independently owned intellectual property rights.
Solving the Donor Corneal Storage Challenge
“This achievement holds great significance for the field of corneal transplantation in our country, bringing renewed hope of sight to many patients with corneal blindness,” said Shi Weiyun, Director of the Corneal Disease Group at the Ophthalmology Branch of the Chinese Medical Association and President of Shandong Provincial Eye Hospital.
China has nearly four million individuals with corneal blindness, yet only around 10,000 undergo successful corneal transplants each year.
Apart from the limited number of donated corneas, a key constraint has been the domestic lack of corneal storage products.
Corneal storage solution is a Class III medical device used for the ex‑vivo preservation of donor corneas.
Due to the small market size and low profitability, manufacturers and importers previously showed little interest in producing or distributing such solutions domestically, meaning no approved corneal storage liquids were available in China.
As a result, the prevailing method remained the outdated eyeball “wet chamber” approach, which requires harvesting the donor’s entire eyeball and completing the transplant within 48 hours of preservation—a procedure that discourages many potential donor families.
“Surveys show that fewer than 20% of potential donor families are willing to donate a whole eyeball; more than 80% prefer donation via in‑situ corneal excision,” explained Shi Weiyun. Corneal storage solution is critical to enabling this in‑situ donation approach.
To meet this clinical need, the team at Shandong Provincial Eye Hospital independently developed a corneal storage solution.
Through continuous refinement, they extended preservation times to reach international advanced levels.
This method not only improves donor tissue utilization but also encourages broader public willingness to donate.
Facing low commercial returns, Shi approached Biodear’s Chief Scientist Zhang Haijun to find a manufacturing partner.
Zhang said that the transition from lab development to production was driven by “a sense of mission.”
“This product generates almost no economic benefit; rather, it is driven by social responsibility and the urgent clinical demand,” he admitted.
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