Alchimia’s Kerasave Corneal Storage Medium Gains FDA’s De Novo Approval

Alchimia’s Kerasave corneal storage medium has received De Novo approval from the FDA as a Class II medical device.

The device, which is used to temporarily preserve human cornea tissue between harvesting and implantation, is indicated for storage of corneas at 2 degrees to 8 degrees Celsius (35.6 to 46.4 degrees Fahrenheit) for up to 14 days.

The prescription-only device is intended for use by physicians or highly skilled personnel, such as eye bank operators, the agency said.

Approximately 43 percent of all devices fall in the Class II category, which is for devices that present a moderate-to-high risk to the patient or user.