4DMT Presents Results Of 4D-150 SPECTRA Clinical Trial In DME And Regulatory Update
Benzinga Newsdesk 1 year ago
BiotechGeneral
4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or dose level4D-150 demonstrated durable and dose-dependent clinical activity with sustained gains in visual acuity and
- 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