4DMT announces positive results from SPECTRA trial evaluating 4D-150 in patients with DME

(Image Credit: AdobeStock/Deborah)

4D Molecular Therapeutics announced positive results from the SPECTRA clinical trial evaluating 4D-150 in patients with diabetic macular edema (DME). The data, including both 52-week primary endpoint and 60-week analyses, were presented at this year's Annual American Society of Retina Specialists (ASRS) Scientific Meeting.

4D-150 is an investigational agent designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. It utilizes the company’s customized and evolved intravitreal vector, R100.

David Almeida, MD, MBA, PhD, who presented the data at the event, commented, “The positive results from the SPECTRA trial demonstrate the tolerability and consistent, durable clinical activity of 4D-150 in DME, […] 4D-150 has the potential to fundamentally transform the treatment of DME by reducing treatment burden with a product that has adherence by design while providing meaningful, lasting vision improvement. This is especially important in DME, which frequently occurs in a working-age population.”

For the SPECTRA trial, the primary objective was to evaluate safety and tolerability and identify the dose level for further evaluation. The study enrolled 22 patients across 3 dose levels, including the phase 3 dose of 3E10 vg/eye (n=9) and supplemental doses of 1E10 vg/eye (n=12) and 5E9 vg/eye (n=1). It was noted that 2 patients dosed in the 1E10 vg/eye missed over 50% of study visits and were considered not evaluable for injection burden or other efficacy parameters.

According to the data, 4D-150 is well-tolerated with no intraocular inflammation at any timepoint over 60 weeks. Additionally, no patients required any modification to the topical corticosteroid regimen.

Patients in the phase 3 dose (3E10 vg/eye [n=9]) sustained a gain of best corrected visual acuity (BCVA) of +9.7 letters, with a reduction of CST, as measured by optical coherence tomography (OCT), of -174 µm.

Additionally, patients treated with the phase 3 dose required substantially fewer supplemental injections compared to patients receiving lower doses or projected on-label aflibercept 2 mg Q8W.

The mean supplemental injections per patient were 1.6 for those who received the phase 3 dose and 3.7 for those on the lower doses. Of the 11 valid participants in the lower doses, only 1 patient was injection-free, while 4 of the 9 in phase 3 were.

David Kirn, MD, co-founder and CEO of 4DMT, commented, “The consistency of dose response, safety, and efficacy data we’ve seen with 4D-150 across all patients evaluated in both DME and wet AMD reinforces our belief that 4D-150 has the potential to become a true backbone therapy and may significantly improve the lives of millions of patients living with retinal vascular disease.”

Following US Food and Drug Administration (FDA) alignment, as communicated in January 2025, the EMA is also aligned 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 planned phase 3 clinical trials in the 4FRONT wet AMD program, would be acceptable as the basis for a marketing authorization application (MAA) submission for 4D-150 in DME.

References:

1. 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