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