Encouraging phase II results for high dose Eylea 8 mg in wet age-related macular degeneration presented at Angiogenesis meeting.- Regeneron

As previously announced, more patients treated with aflibercept 8 mg had no retinal fluid at week 16, when the primary efficacy endpoint was assessed. At this timepoint, 43% (n=23/53) had no fluid in the macula compared to 26% for Eylea (n=14/53) (p=0.0667); and 51% (n=27) had no fluid in the center subfield compared to 34% for Eylea (n=18) (p=0.0770). At week 16, patients in both treatment groups had received three initial doses (administered at weeks 0, 4 and 8), after which dosing was extended to every 12 weeks. In new results presented for the first time, aflibercept 8 mg continued to show numeric improvements in anatomical and vision outcomes compared to Eylea through 44 weeks.

Eyes treated with aflibercept 8 mg were more likely to be dry in the center subfield on optical coherence tomography (OCT) compared to Eylea at every timepoint measured throughout the trial after the initial monthly dosing period. At week 44 when the trial ended, key anatomical and vision changes included: 40% (n=21/53) of patients treated with aflibercept 8 mg did not have fluid in the center subfield compared to 28% (n=15/53) of patients treated with Eylea (nominal p=0.2185). Twice as many patients treated with aflibercept 8 mg (32%, n=17/53) had no macular fluid compared to patients treated with Eylea (15%, n=8/53) (nominal p=0.0395), as measured by spectral domain OCT. Measuring macular fluid provides an evaluation of a larger area of the retina compared to the center subfield and may provide a better understanding of the anatomical effects of treatment in wet AMD. 7.9 average letter improvement from baseline in the aflibercept 8 mg group, compared to 5.1 letters in the Eylea group, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters (nominal p=0.1957). Nearly half (47%) of aflibercept 8 mg patients achieved at least a 10-letter gain (2 lines on a vision test) and more than a quarter (28%) achieved more than 15 letters (3 lines on a vision test), compared to 35% and 18% for patients treated with Eylea, respectively.

Through 44 weeks, adverse events (AEs) in the study eye occurred in 38% (n=20/53) of both aflibercept 8 mg and Eylea patients. There were no serious AEs of intraocular inflammation (including occlusive retinal vasculitis), and no anti-platelet trialists' collaboration (APTC)-defined arterial thromboembolic events. The most common ocular AEs that occurred more frequently in the aflibercept 8 mg group were vitreous detachment (4 aflibercept 8 mg, 2 Eylea ), conjunctival hemorrhage (3 aflibercept 8 mg, 2 Eylea) and retinal tear (2 aflibercept 8 mg, 0 Eylea). There was one patient death in the aflibercept 8 mg unrelated to treatment. The results will be presented at the Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2022 annual meeting on Saturday, February 12.