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Big news! Aflibercept 8 mg first achieved in 89% of patients with extended injection interval up to 16 weeks

Posting time:2022-12-02 07:20:16

Big news! Aflibercept 8 mg first achieved in 89% of patients with extended injection interval up to 16 weeks

Key Messages Aflibercept 8 mg met primary endpoints compared to Aflibercept® in two global pivotal studies in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) (aflibercept 2 mg), achieved non-inferiority improvement in best-corrected visual acuity at week 48 and demonstrated extremely high efficacy persistence in nAMD and DME patients, with 77% of nAMD patients and 89% of DME patients maintaining each 16-week dosing interval and only 5 injections of aflibercept 8 mg in the first year of treatment The safety results are consistent with the approved safety profile of Aflibercept (aflibercept 2 mg) by Bayer These data will be submitted to health regulators outside the U.S. Aflibercept 8 mg first achieved extended injection interval of 16 weeks in 89% of patients Bayer announced today that two pivotal studies of aflibercept 8 mg met their primary endpoints , that is, at week 48, both 12-week interval and 16-week interval dosing regimens met the primary endpoint in patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). In the Phase III PULSAR study in nAMD and the Phase II/III PHOTON study in DME, Aflibercept® (aflibercept 2 mg), aflibercept 8 The mg extended dosing regimen achieved non-inferiority improvement in best-corrected visual acuity (BCVA). The safety results of aflibercept 8 mg in the above studies were consistent with the approved safety profile of Aflibercept (aflibercept 2 mg). Bayer will submit the data to health regulators outside the United States. Jean-François Korobelnik, professor of ophthalmology, chief of the Department of Ophthalmology at the University Hospital of Bordeaux, France, and trial investigator, said, "These groundbreaking results are excellent news for patients; Vision improvement was obtained and also demonstrated a similar safety profile to Aaliyah.” “These two pivotal studies of aflibercept 8 mg showed that nearly 90% of patients with diabetic macular edema and approximately 80% of wet age-related Patients with macular degeneration were able to maintain the dosing regimen at 16-week intervals," said trial investigator David Brown, MD, director of retinal research at Texas State University. Aflibercept's consistent safety profile supports aflibercept 8 mg as a potential new standard of care for these diseases." In two double-blind, active-controlled pivotal studies, PULSAR in nAMD (n=1009) and PULSAR in DME The PHOTON (n=658) study evaluated the efficacy and safety of aflibercept 8 mg versus Alia. Both studies were conducted at multiple centers around the world and were similar in design and endpoints. At Week 48, both studies met the primary endpoint of non-inferiority for aflibercept 8 mg versus Alia. Additional results were as follows: In the 8 mg 16-week interval dose arm of aflibercept, 77% of nAMD patients in the PULSAR study (n=312) and 89% of the DME patients in the PHOTON study (n=156) were able to maintain 16 Weekly injection intervals, with an average of 5 injections in the first year. In the 12-week dosing interval of aflibercept 8 mg, 79% of nAMD patients in PULSAR (n=316) and 91% of DME patients in PHOTON (n=300) were able to maintain a 12-week dosing interval , the average number of injections in the first year was 6. In a pooled pooled analysis of the aflibercept 8 mg dose group, 83% of nAMD patients in the PULSAR study and 93% of the DME patients in the PHOTON study were able to maintain injection intervals of 12 weeks or longer. In these two global pivotal studies, the safety profile of aflibercept 8 mg was similar to the approved safety profile of Aleria, and was consistent with the safety profile of Aleria observed in previous clinical trials. Serious ocular adverse event rates for aflibercept 8 mg in the PULSAR and PHOTON studies compared with Alia ® were: 1.6% vs. 0.6% for PULSAR and 0.6% vs. 0.6% for PHOTON; intraocular inflammation occurred The rate was 0.7% vs. 0.6% in PULSAR. 0.8% vs. 0.6% in PHOTON. There were no clinically meaningful changes in intraocular pressure between treatment groups. In both studies, there were no cases of retinal vasculitis and no new safety concerns. "These data mark the dawn of a new era in which the extended dosing interval of aflibercept 8 mg significantly reduces the treatment burden for the vast majority of patients compared to current regimens that require frequent injections," said Bayer's Prescription Medicines division executive. "All of this is done while improving and maintaining vision, with a safety profile comparable to that of ALIA," said committee member and global head of R&D Christian Rommel. Detailed efficacy and safety data for PHOTON and PULSAR are planned in the near future. Presented at a medical conference. Bayer and Regeneron are jointly developing aflibercept 8 mg. Regeneron holds the exclusive rights to Alia and Aflibercept 8 mg in the United States. Bayer has acquired exclusive marketing rights outside the United States, with the two companies sharing profits from the sale of Alia® equally. Aflibercept 8 mg is still in the research phase and its safety and efficacy have not been evaluated by any regulatory agency. About nAMD and DME Neovascular (wet) age-related macular degeneration (nAMD) is a rapidly progressive eye disease that, if left untreated, can lead to vision loss in as little as three months. nAMD is one of the leading causes of irreversible blindness and visual impairment worldwide. nAMD is an age-related disease. When abnormal blood vessels grow and cause fluid leakage under the macula, it affects the macula, the area responsible for sharp central and fine vision. The leaking fluid can damage the structure of the macula and eventually cause macular scarring, which can lead to vision loss. Worldwide, 196 million people have AMD, and this number is expected to increase to 288 million by 2040. DME is a common complication in the eyes of people with diabetes. Diabetic macular edema occurs when high blood sugar causes damage to the blood vessels in the eye and fluid leaks into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people currently suffer from diabetic retinopathy (DR), which can progress to a more serious condition called diabetic macular edema (DME).

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