What is the status of the clinical trials 4D-150 for both DME and AMD?

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4D Molecular Therapeutics (4DMT) provided an update on the timelines for their therapeutic candidate, 4D-150. This candidate is currently being evaluated for the treatment of patients with wet age-related macular degeneration (AMD) and for diabetic macular edema (DME).

4D-150 for Wet AMD

The 4FRONT global phase 3 program has several components to all the company to advance the evaluation of this candidate. 4FRONT-1 is the North American phase 3 clinical trial, which has exceeded the company’s early projections for initial site enrollment and site activation. Topline, 52-week data is expected in the first half of 2027. The second portion of this program is 4FRONT-2, also a phase 3 trial, was initiated in June of 2025, ahead of the company’s projected schedule.

The PRISM trials are also underway. The 2-year data from the phase1/2a and the 18-month data from the phase 2b cohorts are expected in Q4 2025.¹

4D-150 for DME

The SPECTRA clinical trial has seen positive 60-week results as of May 3, 2025. In this trial, across all dose levels to date, 4D-150 was well tolerated with no intraocular inflammation observed at any timepoint or dose level. Post-three loading doses of aflibercept, 3E10 vg/eye, the Phase 3 dose demonstrated strong signals of clinical activity, with sustained gain of BCVA of +9.7 letters and reduction of CST of -174 µm from baseline.¹

Supplemental injections were used in the SPECTRA trial, particularly the trial used a stringent supplemental aflibercept criteria to maximize patient safety while assessing initial clinical activity. Clear dose response observed for the Phase 3 dose vs. lower doses (58% fewer injections). Phase 3 dose achieved 78% reduction in injection burden vs. projected on-label aflibercept 2mg Q8W.¹

Data from the SPECTRA trial was shared at the American Society of Retina Specialists (ASRS) annual scientific meeting by David Almeida, MD, MBA, PhD. The meeting was held in Long Beach, California, from July 30 through August 2, 2025.²

FDA and EMA status for 4D-150 for DME

The company has received alignment from the FDA and EMA that a single Phase 3 clinical trial, based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials combined with data from the 2 ongoing wet AMD Phase 3 clinical trials, would be acceptable as the basis for a marketing authorization application submission for 4D-150 in DME.¹

4DMT has also received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for 4D-150 for the treatment of DME. Next steps pending final FDA and EMA alignment on Phase 3 clinical trial design and funding pathway.¹

Reference:

1. 4DMT Reports Second Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones. 4D Molecular Therapeutics. News Release. August 11, 2025. Accessed August 14, 2025. https://4dmt.gcs-web.com/news-releases/news-release-details/4dmt-reports-second-quarter-2025-financial-results-operational

2. 4DMT Presents Positive 60-Week Results from 4D-150 SPECTRA Clinical Trial in DME and Regulatory Update. Published July 31, 2025. Accessed August 4, 2025. https://www.globenewswire.com/news-release/2025/07/31/3125378/0/en/4DMT-Presents-Positive-60-Week-Results-from-4D-150-SPECTRA-Clinical-Trial-in-DME-and-Regulatory-Update.html