FDA Grants Orphan Drug Designation to Trethera’s TRE-515 for Optic Neuritis

The FDA has granted Orphan Drug status to Trethera’s investigational drug TRE-515 for treatment of patients with optic neuritis, a rare autoimmune disease that leads to loss of vision in one or both eyes.

The company believes that certain autoimmune diseases could benefit from treatment with TRE-515, which is also being evaluated as monotherapy or in combination to target cancer.

TRE-515 inhibits an enzyme that plays a role in generating DNA precursors that can influence the growth of certain tumors.

The FDA grants Orphan Drug designations to investigational drugs that show potential to prevent, diagnose or treat a rare disease or condition.