4D Molecular To Test Its Wet AMD Gene Therapy In Patients

The FDA has signed off 4D Molecular Therapeutics' FDMT Investigational New Drug Application (IND) for 4D-150 for wet age-related macular degeneration (wet AMD).
The active IND enables the initiation of a 4D-150 Phase 1/2 clinical trial, expected before year-end.
4D-150 is a dual-transgene intravitreal gene therapy encompassing the R100 capsid, invented through Therapeutic Vector Evolution.
The Phase 1/2 clinical trial is a dose-escalation and randomized, controlled, masked expansion trial of intravitreal 4D-150.
The trial will enroll approximately 60 adults with wet AMD.
The primary endpoints of the study are safety and tolerability.
Secondary endpoints include the number of supplemental aflibercept injections received and change from baseline in best-corrected visual acuity (BCVA) over time.
Related content: Benzinga's Full FDA Calendar.
Price Action: FDMT stock is up 3.67% at $27.00 during the premarket session on the last check Wednesday.