Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Aflibercept 8 mg is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.Ībout VEGF and Eylea (aflibercept solution for injection into the eye) This new, high molar dose aflibercept formulation enables a greater amount of medicine to be administered with each treatment and could potentially extend the time between doses while retaining the efficacy and safety profile seen with Eylea (aflibercept 2 mg). Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.Īflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea in the United States. are collaborating on the global development of aflibercept 8 mg. The clinical data from the trials will be presented at an upcoming scientific meeting.īayer and Regeneron Pharmaceuticals, Inc. The PHOTON trial included 660 patients and PULSAR 1,016 patients. The primary endpoint for both trials is the mean change in best-corrected visual acuity (BCVA) at week 48. The PHOTON and PULSAR trials are both multi-centres, randomized, double-masked, active-controlled clinical trials to assess the efficacy and safety of aflibercept 8 mg in treatment intervals of 12 weeks and 16 weeks compared to aflibercept 2 mg administered at an interval of 8 weeks, after the initial loading phase. This translates for many patients into lower treatment burden and a higher quality of life.” With the new aflibercept 8 mg formulation we have shown in two major studies that we can for the majority of all patients with neovascular age-related AMD and DME extend the time between the treatments up to 16 weeks without compromising their visual acuity. We have already seen that certain patients are able to achieve excellent visual outcomes on extended dosing intervals up to 16 weeks with Eylea 2 mg. “Neovascular age-related AMD is one of the leading causes of irreversible blindness and around one third of people with diabetes go on to develop diabetic retinopathy in their lifetimes. Christian Rommel, Member of the Executive Committee of Bayer AG`s Pharmaceutical Division and Head of Research and Development. ![]() This is our motivation to optimise treatment plans and drive change for patients,“ said Dr. ![]() “Although 90 % of vision loss is preventable, globally there are approximately 1.1 billion people who are impacted by vision loss. Eylea (aflibercept 2 mg) is the gold standard for treatment of nAMD and DME for a decade. Aflibercept 8 mg is a new formulation that was jointly developed by the companies to reduce the treatment burden in treatment intensive patients and those already successfully managed with their current therapy through further extending the injection intervals. In the 8 mg treatment arm with injections every 16 weeks 77% of patients in PULSAR and 89% in PHOTON achieved the same visual acuity outcomes as the comparator arm with Eylea given every 8 weeks. Both studies have three treatment arms, with participants randomised to receive either aflibercept 8 mg every 16 weeks, every 12 weeks or aflibercept 2 mg every 8 weeks, after 3 initial 4-weekly loading doses. Both trials met their primary endpoints, demonstrating non-inferiority for aflibercept 8 mg versus Standard of Care (SoC) EyleaTM (aflibercept 2 mg) in mean change in best-corrected visual acuity (BCVA) after 48 weeks. announced today the topline results of their Phase III PULSAR and Phase II/III PHOTON clinical trials, evaluating the safety and effectiveness of aflibercept 8 mg in neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME). ![]() Berlin, September DD, 2022 – Bayer and Regeneron Pharmaceuticals, Inc.
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