4D Molecular Therapeutics Rallies On Heels Of Diabetes-Related Vision Study

Shares of 4D Molecular Therapeutics FDMT are currently up over 20.6% after the company released positive results from its Spectra trial.

The Spectra trial evaluates 4D-150 in patients with diabetic macular edema (DME). DME is a serious eye condition that can cause vision loss in people with diabetes.

The data included both the 52-week primary endpoint and 60-week analyses.

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Efficacy Results Through 60 Weeks: (n=22)

• The trial utilized stringent supplemental aflibercept criteria to maximize patient safety while assessing initial clinical activity.
• Phase 3 Dose: Showed a sustained gain of best corrected visual acuity (BCVA) of +9.7 letters.
• The data also showed a sustained improvement in anatomic control, with reduction of CST, as measured by optical coherence tomography (OCT), of -174 µm.
• Post-aflibercept loading doses (3), patients treated with the Phase 3 dose required substantially fewer supplemental injections compared to patients receiving lower doses or projected on-label aflibercept 2mg Q8W.
• Phase 3 dose (3E10 vg/eye) achieved a clinically meaningful 78% reduction in treatment burden vs. projected on-label aflibercept 2mg Q8W.

Eylea (aflibercept) is a commonly used treatment from Regeneron Pharmaceuticals Inc. REGN.

Safety Results Through 60 Weeks:

• 4D-150 was well tolerated with no intraocular inflammation at any time point.
• No subjects required modification to the topical corticosteroid regimen, and all patients are currently off corticosteroids.
• No hypotony, endophthalmitis, vasculitis, choroidal effusions or retinal artery occlusions were reported.
• The mean intraocular pressure was within normal limits.

According to 4DMT chief executive David Almeida, the SPECTRA trial results demonstrate “consistent, durable clinical activity of 4D-150 in DME, highlighting the potential for the product candidate to become a backbone therapy that can dramatically reduce treatment burden compared to the labeled regimen of standard-of-care aflibercept 2mg every eight weeks.”

4D-150 DME Phase 3 Regulatory Update

The EMA has agreed, in line with the FDA, that a single Phase 3 trial—supported by existing SPECTRA and PRISM data along with two planned Phase 3 studies—would be sufficient for a marketing authorization application for 4D-150 in diabetic macular edema (DME).

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