EURETINA 2026: 2-year SPECTRA results and the phase 3 programme for 4D-150 gene therapy in DMO

At the 26th EURETINA Congress in Vienna, Arshad Khanani, MD, FASRS, of Sierra Eye Associates, reviewed 2-year results from the SPECTRA study of 4D-150 (4D Molecular Therapeutics), an intravitreal gene therapy for diabetic macular oedema (DMO). He also outlined the global phase 3 programme that has followed. The SPECTRA data reflect outcomes after 1 injection of 4D-150.

Safety comes first

Khanani identified safety as the most important finding for the field. He noted that with other intravitreal gene therapies, patients with DMO have experienced adverse events that led to permanent vision loss. In SPECTRA, no patients experienced any events of intraocular inflammation.

Khanani acknowledged the limits of the data. “Obviously, it's a small phase 1/2 trial looking at safety, but it gives me hope that we can now take this treatment forward for our patients in larger studies,” he said.

Efficacy and treatment burden

Beyond safety, Khanani reported that SPECTRA showed efficacy in terms of visual acuity gains and anatomic improvements. He also described a significant reduction in treatment burden for patients who received 4D-150.

Moving into phase 3

Building on these results, the global phase 3 programme for 4D-150 in DMO has launched. The programme is enrolling treatment-naive patients with DMO. These patients receive a single injection of 4D-150 after loading doses, and the programme compares this approach with aflibercept (Eylea; Regeneron) given every 8 weeks.

Khanani enrolled the first patient in the phase 3 4SIGHT trial. He explained that, based on regulatory feedback, only 1 trial will be required for DMO.

Looking ahead

Khanani said he looks forward to enrolling more patients in 4SIGHT. He hopes the trial will confirm “a gene therapy that can be safe and effective” for patients with DMO while also reducing the treatment burden associated with current therapy.