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4DMT Announces Positive Interim Data from 4D-150 SPECTRA Clinical Trial in DME and Alignment with FDA on Registrational Path
3 minutes ago, 5:00 AM PST
Via GlobeNewswire
FDMT
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Across all DME patients dosed to date, 4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or dose level
3E10 vg/eye demonstrated strong signals of clinical activity with sustained gain of BCVA of +8.4 letters and reduction of CST of -194 µm from baseline through Week 32
3E10 vg/eye achieved an 86% reduction in injection burden vs. projected on-label aflibercept 2mg Q8W and dose response with 61% reduction vs. 1E10 vg/eye, with 0.6 mean supplemental injections per patient through Week 32
FDA aligned with proposed single Phase 3 clinical trial being acceptable for the basis of a BLA submission for 4D-150 in DME, based on review of data from SPECTRA and PRISM (wet AMD) clinical trials to date and planned global Phase 3 clinical development program for wet AMD
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