4DMT Presents Results Of 4D-150 SPECTRA Clinical Trial In DME And Regulatory Update

Benzinga·07/31/2025 20:25:24

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4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or dose level
4D-150 demonstrated durable and dose-dependent clinical activity with sustained gains in visual acuity and anatomic control
Phase 3 dose (3E10 vg/eye) achieved clinically meaningful 78% reduction in treatment burden vs. projected on-label aflibercept 2mg Q8W
EMA aligned with proposed single Phase 3 clinical trial being acceptable for regulatory submission for 4D-150 in DME, consistent with previously announced alignment with FDA

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