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On February 11, 2022, Regeneron Pharmaceuticals announced positive results from a proof-of-concept Phase 2 clinical trial of aflibercept in wet age-related macular degeneration (AMD)
.
The trial was designed to evaluate the efficacy and safety of an investigational high-dose level of 8 mg aflibercept compared to the approved 2-mg dose level of aflibercept (trade name Eylea)
Wet AMD is the leading cause of vision loss in people over the age of 60, with approximately 20 million patients worldwide
.
When abnormal blood vessels called choroidal neovascularization (CNV) grow into the macula, they can cause fluid and blood to leak, causing scar tissue to grow and destroy the central retina
Aflibercept is an ophthalmic injection containing a vascular endothelial growth factor (VEGF) inhibitor
.
Its mechanism of action is to block angiogenesis by blocking the growth factor VEGF-A and placental growth factor involved in angiogenesis, thereby blocking the formation of new blood vessels and reducing intraocular vascular permeability
This randomized, single-blind phase 2 clinical trial enrolled 106 treatment-naïve patients with wet AMD
.
Patients were randomized to receive 8 mg or 2 mg of aflibercept, and efficacy endpoints were assessed by optical coherence tomography (OCT) to detect the presence or absence of retinal fluid in the center subfield of the retina
The key results at 44 weeks are as follows:
40% (n=21/53) of patients in the 8 mg group and 28% (n=15/53) of patients in the 2 mg group were fluid-free in the central subdomain (p=0.
2185)
.
32% (n=17/53) of patients in the 8 mg group had no macular fluid, twice as many as the 2 mg group (15%, n=8/53) (p=0.
0395)
.
Compared with the central subfield, the macular fluid assesses a larger retinal area and may provide a better understanding of the anatomical effects of treatment
According to the Early Treatment Diabetic Retinopathy Study (ETDRS) letter measure, the mean improvement from baseline was 7.
Nearly half (47%) of patients in the 8 mg group achieved an improvement in visual acuity of at least 10 letters, and more than a quarter (28%) achieved an improvement of more than 15 letters, compared with 35% and 35% in the 2 mg group.
By 44 weeks, the safety profile was similar between the two groups
References:
[1] Regeneron Presents Encouraging Phase 2 Results For High-Dose Aflibercept 8 Mg In Wet Age-Related Macular Degeneration At Angiogenesis Meeting.
(Original abridged)
