The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted eight to eight on the question of whether the...
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted market authorization for Eylea 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)
-Bayer has submitted an application to the Japanese Ministry of Health, Labor, and Welfare (MHLW) seeking approval of aflibercept 8 mg for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Bayer announced two-year (96 weeks) topline results of the pivotal clinical trial PULSAR in patients with neovascular (wet) age-related macular degeneration (nAMD). The data reinforce sustained vision gains with unprecedented extended treatment intervals of aflibercept 8 mg reaching up to 24 weeks with efficacy and safety comparable to the current standard of care Eylea (aflibercept 2 mg) with fixed intervals of 8 weeks.
The Lancet has published clinical trial data for aflibercept 8 mg (Eylea 8 mg) from the pivotal phase III PULSAR study in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON study in diabetic macular edema (DME) in the first year of treatment (at week 48).
Regeneron Pharmaceuticals, Inc. announced the first presentation of positive two-year (96 weeks) results from the pivotal PHOTON trial investigating aflibercept 8 mg with 12- and 16-week dosing regimens, compared to Eylea (aflibercept) Injection, in patients with diabetic macular edema (DME). The results were presented at the American Society of Retina Specialists (ASRS) annual meeting.
Regeneron Pharmaceuticals announced results from its Phase II proof-of-concept trial evaluating an investigational 8 mg high dose of aflibercept compared to the currently-approved 2 mg dose of Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending aflibercept 8 mg with extended treatment intervals in two major retinal eye diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) for approval