SILVER SPRING, Md. A panel of medical experts deemed a proposed eye drop drug by River Plate Biotechnology as not safe nor effective enough to treat patients with dry-eye disease.
The vote was 6 to 1 against the product. The Food and Drug Administration will take the panel’s thoughts into consideration when making a final decision on whether to approve the drug.
If approved, River Plate’s Rejena will be used to treat dry-eye disease, which affects about 5 million people in the United States, the company said.
Allen Rutzen, a panel member who voted in favor of Rejena, said, “Although I’m not overly impressed with the data,” the drug did meet standards for approval.