4D Molecular presents SPECTRA data at ASRS meeting

4D Molecular (FDMT) announced results from the SPECTRA clinical trial evaluating 4D-150 in patients with diabetic macular edema and alignment with the European Medicines Agency on a registrational pathway for 4D-150 in DME. The data, which included both the 52-week primary endpoint and 60-week analyses, were presented in an oral presentation at the 43rd Annual American Society of Retina Specialists Scientific Meeting. 4D-150 was well tolerated with no intraocular inflammation at any timepoint. 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. Mean intraocular pressure was within normal limits. Utilized stringent supplemental aflibercept criteria to maximize patient safety while assessing initial clinical activity. Phase 3 dose sustained gain of best corrected visual acuity of +9.7 letters. Sustained improvement in anatomic control, with reduction of CST, as measured by optical coherence tomography, of -174 micrometers. Post-aflibercept loading doses, patients treated with Phase 3 dose required substantially fewer supplemental injections compared to patients receiving lower doses or projected on-label aflibercept 2mg Q8W.