4DMT Presents Positive 52-Week Results from Phase 2b Cohort of PRISM Wet AMD Study and Long-term Durability Data Supporting 4D-150 4FRONT Global Registration Program - Seite 2
Topline 52-Week Efficacy Results for 4D-150 3E10 vg/eye (Planned Phase 3 Dose) from Phase 2b Population Extension Cohort of PRISM (Data Cut-Off January 15, 2025):
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Phase 2b (n=30): Broad Wet AMD Disease Activity
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Supplemental aflibercept injections:
- 83% reduction, representing 0.97 mean supplemental injections per patient over 52-weeks vs. 6.0 injections projected with on-label aflibercept 2 mg Q8W
- 70% 0-1 injection
- 57% injection-free
- Improved and maintained best corrected visual acuity (BCVA) of +2.2 letters
- Durable central subfield thickness (CST) improvement with fewer fluctuations, as measured by optical coherence tomography (OCT), of -11 µm; -13 µm in supplemental injection-free patients
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Supplemental aflibercept injections:
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Phase 2b (n=15): Recently Diagnosed Subgroup
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Supplemental aflibercept injections:
- 94% reduction, representing 0.33 mean supplemental injections per patient over 52-weeks vs. 6.0 injections projected with on-label aflibercept 2 mg Q8W
- 87% 0-1 injection
- 80% injection-free
- Improved and maintained BCVA of +3.1 letters
- Durable CST improvement with fewer fluctuations, as measured by OCT, of -10 µm; -20 µm in supplemental injection-free patients
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Supplemental aflibercept injections:
4D-150 Safety Update from PRISM (Data Cut-Off January 15, 2025):
- 4D-150 continues to be well tolerated during up to three years of follow up in all patients treated with 3E10 vg/eye
- 2.8% (2 of 71) had 4D-150–related 1+ intraocular inflammation (IOI) (SUN/NEI scales), which were transient 1+ vitreous cells noted at a single timepoint, as previously reported
- 99% (70 of 71) completed steroid prophylaxis taper on schedule
- 99% (70 of 71) remained completely off steroids
- No 4D-150–related hypotony, endophthalmitis, vasculitis, occlusive/non-occlusive retinal vasculitis, or choroidal effusions observed to date
"The promise of 4D-150 for both patients and clinicians lies in its potential to tackle one of the most pressing unmet needs in vascular retinal diseases—providing a long-lasting, effective treatment option that reduces the frequent burden of bolus anti-VEGF injections,” said Dante Pieramici, M.D., a principal investigator of the PRISM study and member of the 4DMT Ophthalmology Advisory Board. “4D-150 offers a profound shift in how we manage our patients’ care, potentially freeing them from the ongoing challenges of injection frequency while ensuring they maintain the vision improvement characteristic of current standard of care. The data from the PRISM study gives me great hope that 4D-150 can become the backbone of future retinal treatments for wet AMD, offering both clinical benefit and better quality of life for our patients."