4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema


The US FDA has cleared an IND of 4D-150, an R100 vector-based intravitreal genetic medicine for DME. The P-II trial (SPECTRA) evaluates 4D-150 vs aflibercept in a ratio (1:1:1) in 54 patients with DME while patient enrolment is expected to be initiated in Q3’23
The initial cohort 1 results from the P-I portion of the P-I/II trial (PRISM) trial showed a ~95% reduction in annualized anti-VEGF injection rate further validating R100 intravitreal vector potential for other large market eye diseases incl. geographic atrophy
The interim data for dose cohorts 1/2/3 is expected to be presented at ARVO 2023. The company is currently enrolling patients in the P-II portion of the P-I/II trial (PRISM) of 4D-150

Ref: Globenewswire | Image: 4D Molecular Therapeutics

Related News:- Bayer Reports P-III (PULSAR) and P-II/III (PHOTON) Trial Results of Aflibercept for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema