Nacuity Pharmaceuticals Secures FDA Breakthrough Therapy Designation For NPI-001 Tablets In Retinitis Pigmentosa

Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing therapies for retinitis pigmentosa, cataracts, and other diseases driven by oxidative stress, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to NPI-001 (N-acetylcysteine amide) tablets. NPI-001 is Nacuity’s proprietary investigational therapy for the treatment of patients with retinitis pigmentosa (RP).

The FDA’s decision reflects early clinical evidence suggesting that NPI-001 may deliver significant treatment benefits for people living with retinitis pigmentosa, a serious disease that causes progressive vision loss and blindness. Commenting on the announcement, G. Michael Wall, Ph.D., Senior Vice President and Chief Scientific Officer of Nacuity Pharmaceuticals, said that the designation confirms the potential of NPI-001 and marks an important milestone in advancing the program into later stages of development.

Breakthrough Therapy Designation is reserved for drug candidates intended to treat serious or life-threatening conditions where preliminary data indicate a meaningful improvement over available therapies on clinically relevant outcomes. In addition to the benefits already granted under Fast Track Designation, NPI-001’s BTD status provides Nacuity with increased FDA guidance on drug development and greater organizational support to expedite the pathway toward approval.