The following transcript has been edited for clarity:
Hello, my name is David Almeida, MD, and I'm an investigator with Erie Retina Research and the Centers for Advanced Surgical Exploration (caseX). I just presented the interim results of SPECTRA, a phase 2a clinical trial evaluating 4D-150 (4D Molecular Therapeutics) for diabetic macular edema, in Long Beach at the American Society of Retina Specialists (ASRS) annual meeting.
Our objective in SPECTRA was to evaluate the safety and the clinical activity of this novel gene therapy. 4D-150 as a genetic medicine is unique. It’s an investigational intravitreal genetic medicine that is designed to deliver a dual transgene cassette that produces both aflibercept and targets VEGF-C inhibitor. SPECTRA is a multicenter trial; we enrolled adult patients with diabetic macular edema. In the trial, patients received 3 initial aflibercept loading-dose intravitreal injections, followed by a single injection of 4D-150.
The results I’ve presented here at ASRS through [60] weeks are very encouraging and compelling. A single dose of 4D-150 was well tolerated, and importantly, really looking at safety of this transgene, there was no events of 4D-150–related serious adverse events and there was no events of 4D-150–related intraocular inflammation, which is superlative and wonderful to see. We saw significant clinical improvements as well. In the high-dose group, patients gained an average of 8.4 letters, and we saw anatomical improvements with a central subfield thickness reduction of 194 µm.
Crucially, when we think about what patients are asking us for currently, it is really about treatment burden—more durable treatment without losing safety or efficacy. We see that the single injection of 4D-150 dramatically reduced the need for supplemental anti-VEGF injections, with the high-dose groups seeing an 84% reduction in treatment burden. That is over 80%, almost 90% reduction in treatment burden with a safe and efficacious potential medicine. Exciting, I think, for the investigators and patients involved.
In conclusion, at ASRS I was privileged to present that a single injection of 4D-150 as seen in the interim results of SPECTRA shows a favorable safety profile with sustained anatomical and visual gains and significantly lessening the treatment burden for patients. Many thanks for your attention. RP
