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Bayer Reports P-III (PULSAR) and P-II/III (PHOTON) Trial Results of Aflibercept for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema

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Bayer Reports P-III (PULSAR) and P-II/III (PHOTON) Trial Results of Aflibercept for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema

Shots:

  • 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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