Investigational status

“All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority.” (opens the source at this quote in a new tab)

Current development phase and indications

“The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema.” (opens the source at this quote in a new tab)

FDA regenerative medicine advanced therapy designation

“the U.S. Food and Drug Administration (FDA) has granted the RMAT designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD).” (opens the source at this quote in a new tab)
“Receiving RMAT designation offers sponsor companies all the benefits of the fast track and breakthrough therapy designation programs, allowing for early, close and frequent interactions with the FDA with the goal of expediting drug development.” (opens the source at this quote in a new tab)

EMA PRIME designation

“the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD).” (opens the source at this quote in a new tab)

Designations covering both wet AMD and diabetic macular edema

“and RMAT designation for 4D-150 for treatment of DME, which highlights recognition from regulatory bodies of the potential of 4D-150 to address significant unmet medical needs for both wet AMD and DME.” (opens the source at this quote in a new tab)

4FRONT-1 enrollment completion and expected topline data

“The 4D-150 4FRONT-1 Phase 3 trial enrolled in 11 months in a treatment-naïve large market patient population.” (opens the source at this quote in a new tab)

“Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in Q2 2027” (opens the source at this quote in a new tab)

4FRONT-2 enrollment completion and expected topline data

“Enrollment completed in June 2026 with N>500 expected to be randomized; topline data expected in H2 2027” (opens the source at this quote in a new tab)

“4FRONT-2 52-week topline data is expected in H2 2027.” (opens the source at this quote in a new tab)

Phase 3 design alignment with FDA, EMA, and Japan Pharmaceuticals and Medical Devices Agency

“Target enrollment per study is 480 patients randomized 1:1 to 4D-150 or the aflibercept comparator arm, providing approximately 90% power with a noninferiority margin of 4 letters as aligned with the Japan Pharmaceuticals and Medical Devices Agency and EMA and over 90% power with a noninferiority margin of 4.5 letters per FDA guidance.” (opens the source at this quote in a new tab)

“Study design has been aligned with feedback from U.S. Food and Drug Administration (FDA) under RMAT designation” (opens the source at this quote in a new tab)

Licensure pathway in the second indication

“In January 2025, we also announced alignment with the FDA that a single Phase 3 clinical trial would be acceptable as the basis of a biologics license application (“BLA”) submission for 4D-150 in DME.” (opens the source at this quote in a new tab)

Biologics license application submission date, marketing authorization application, and approval dates

No evidence found.

Regulatory submission

No evidence found.

Launch

No evidence found.