4DMT Provides New 60-Week Results for Gene Therapy Candidate for DME
4D Molecular Therapeutics (4DMT) announced interim results from its SPECTRA phase 2a clinical trial evaluating 4D-150 for diabetic macular edema (DME). The data were presented at the 43rd Annual American Society of Retina Specialists (ASRS) scientific meeting by David Almeida, MD, PhD.[1]
Key Takeaways
1. Durable Visual and Anatomic Response at Phase 3 Dose
Patients receiving the Phase 3 dose (3E10 vg/eye) of 4D-150 demonstrated:
+9.7 letter gain in best corrected visual acuity (BCVA)
174 µm reduction in central subfield thickness (CST) on OCT
Significantly fewer supplemental aflibercept injections:
1.6 injections at Phase 3 dose vs. 7.0 projected for on-label aflibercept 2mg Q8W
4 of 9 patients remained injection-free through 60 weeks
Favorable Safety Profile Through 60 Weeks
Among 22 enrolled patients:
No intraocular inflammation, vasculitis, or retinal artery occlusion
No adverse steroid-related effects; all patients discontinued corticosteroids without issue
Stable intraocular pressure with no reports of hypotony, endophthalmitis, or choroidal effusions
EMA and FDA Regulatory Alignment
4DMT said it has secured alignment from both the FDA and EMA on a single phase 3 trial as sufficient for registrational submission:
EMA acceptance follows earlier FDA agreement in January 2025
The submission will leverage data from:
The SPECTRA (DME) and PRISM (wet AMD) trials
Two planned 4FRONT Phase 3 trials in wet AMD
4DMT said this dual-agency alignment accelerates the path to potential market approval in two major retinal indications with overlapping disease mechanisms.
4D-150 is a novel intravitreal gene therapy candidate that delivers a combination of aflibercept and anti-VEGF-C through a single injection. Built on the company’s R100 vector platform, evolved specifically for safe and efficient retinal delivery, 4D-150 aims to provide sustained anti-VEGF expression, extended durability (multi-year efficacy), and reduced treatment burden, especially critical for working-age populations affected by DME
Source: Data presented by David Almeida, M.D., MBA, Ph.D. at ASRS 2025. For more detailed results, please refer to the presentation: “Interim Results from the SPECTRA Phase 2a Clinical Trial Evaluating Intravitreal 4D-150 in Adults with Diabetic Macular Edema.”