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Investing.com -- 4D Molecular Therapeutics (NASDAQ:FDMT) stock rose 36% after the company announced positive 60-week results from its 4D-150 SPECTRA clinical trial in diabetic macular edema (DME) and provided a regulatory update.
The late-stage biotechnology company reported that its 4D-150 treatment demonstrated durable and dose-dependent clinical activity with sustained gains in visual acuity and anatomic control. At the Phase 3 dose level (3E10 vg/eye), patients achieved a 78% reduction in treatment burden compared to projected on-label aflibercept 2mg every eight weeks.
The company also announced that the European Medicines Agency (EMA) has aligned with its proposed single Phase 3 clinical trial being acceptable for regulatory submission for 4D-150 in DME, consistent with previously announced alignment with the FDA.
According to the data presented at the 43rd Annual American Society of Retina Specialists Scientific Meeting, 4D-150 continued to be well tolerated with no intraocular inflammation observed at any timepoint or dose level across the 22 patients enrolled in the trial.
Efficacy results through 60 weeks showed that patients receiving the Phase 3 dose experienced a sustained gain of best corrected visual acuity of +9.7 letters and a reduction of central subfield thickness of -174 µm, indicating improved anatomic control.
The trial also demonstrated a significant reduction in the need for supplemental injections. Patients treated with the Phase 3 dose required a mean of 1.6 supplemental injections compared to 3.7 for lower doses and 7.0 for projected on-label aflibercept treatment.
David Kirn, Co-founder and Chief Executive Officer of 4DMT, noted that the company has secured a streamlined regulatory path with both FDA and EMA alignment for a single Phase 3 DME trial to complement its wet AMD (NASDAQ:AMD) program.
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