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Key takeaways:
• Patients treated with the gene therapy maintained visual acuity through 2 years.
• They also experienced a reduction in supplemental injections.
A single intravitreal injection of 4D-150 helped patients with wet age-related macular degeneration maintain visual acuity for up to 2 years, according to a press release from 4DMT.
The company announced positive results from the phase 1/2 PRISM trial that included three cohorts of patients. The phase 2b group included 30 patients with broad disease activity. The phase 2b subgroup included 15 patients with broad disease activity diagnosed within 6 months of starting the trial. The phase 1/2a cohort included 24 patients with severe, recalcitrant disease activity, according to the release.
The therapy demonstrated consistent maintenance of best corrected visual acuity and consistent control of central subfield thickness through 2 years, according to the release.
Patients also maintained a reduction in supplemental injections following 4D-150 treatment at year 1, year 1.5 and year 2. Additionally, they maintained a consistent reduction in supplemental injections in 6 month intervals following 4D-150 treatment, according to the release.
Patients in all three cohorts experienced consistent dose response on treatment burden that favored the higher dose (3E10 vg/eye) compared with the lower dose (1E10 vg/eye).
The drug was well-tolerated, and there were no new safety or intraocular inflammation findings through 3.5 years of follow-up, according to the release.
The company is continuing enrollment in the phase 3 4FRONT-1 trial and expects to complete enrollment in the global 4FRONT-2 trial in the second half of 2026.
“4D-150 has the potential to transform care for patients with AMD by reducing treatment burden and maintaining vision,” David Kirn, MD, co-founder and CEO of 4DMT, told Healio. “Unlike the current standard of care, which requires injections every 4 to 16 weeks, 4D-150 is designed as a single intravitreal injection that may maintain disease control for an extended period, cutting office visits from as many as 10 times a year to just 1 to 2. This regimen has potential to improve quality of life aspects for patients such as eliminating frequent travel for appointments, long clinic waits and repeated imaging.”
Sources/Disclosures
Source:
Press Release
Disclosures: Kirn reports being CEO and a co-founder of 4DMT.
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