Bayer Reports P-III (PULSAR) and P-II/III (PHOTON) Trial Results of Aflibercept for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema
- The P-III (PULSAR) trial in nAMD & P-II/III (PHOTON) trial in DME evaluated aflibercept (8mg) with 12 and 16wk. dosing regimens vs Eylea (2 mg, q8w)
- The trial met its 1EPs of non-inferiority of aflibercept for BCVA @48wk., following initial monthly doses, 77% of nAMD & 89% of DME patients maintained q16w dosing intervals while 83% & 93% at ≥12wks. @48wk. in the pooled analysis & showed sustained visual acuity. The safety was consistent with the well-established safety profile of Eylea
- Rates of intraocular inflammation (0.7% vs 0.6%) & (0.8% vs 0.6%) in both trials; patients with IOP ≥35mmHg pre or post-inj. (0.6% vs 0.3%) & (0.2% vs 1.2%), no cases of occlusive retinal vasculitis or endophthalmitis were seen & non-ocular events were balanced with no new signals
Ref: Bayer | Image: Bayer
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