4D-150 is being evaluated in the 4FRONT-1 clinical trial, a Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150 in wet AMD. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms will be eligible for supplemental aflibercept injections. 4FRONT-1 is evaluating treatment naïve wet AMD patients at sites in North America.
4D-150 will be evaluated in the 4FRONT-2 clinical trial, a Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150 in wet AMD. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms will be eligible for supplemental aflibercept injections. 4FRONT-2 will be evaluated in both treatment naïve and recently diagnosed, treatment experienced wet AMD patients globally and is expected to initiate in Q3 2025.
4D-150 is being evaluated in the PRISM clinical trial, a Phase 1/2 dose-escalation and randomized, controlled, masked expansion, and extension study of intravitreal 4D-150 in adults with wet AMD. The primary endpoints of the study are safety and tolerability. Secondary endpoints include the number of supplemental aflibercept injections over 52 weeks and change from baseline in best corrected visual acuity (BCVA) and central subfield thickness (CST).
4D-150 is being evaluated in Part 1 of the SPECTRA clinical trial, a study of intravitreal 4D-150 genetic medicine in adults with DME. The primary endpoint of this study is the annualized number of aflibercept injections in the study eye. Secondary endpoints include safety and tolerability, change from baseline in BCVA, CST and percentage of subjects with improvement in the diabetic retinopathy severity scale.