Ocugen said OCU400 won orphan drug designation, RMAT designation, priority designation and provisional approval, and that it is in Phase 3.

The company said the treatment targets a broad RP indication and that it aims to treat patients within 90 days.

Ocugen said it plans to supply OCU400 through an EAP, expects topline data in 1Q 2027, and plans a BLA submission in 2Q 2027.

Highlights

  • Ocugen said OCU400 won orphan drug, RMAT and priority designations.
  • The treatment is in Phase 3 and has provisional approval.
  • Topline data are expected in 1Q 2027, and Ocugen’s BLA submission is set for 2Q 2027.