Aflibercept 8 mg initially to attain prolonged injection periods of 16 weeks in approximately 89% of clients

Berlin, September 8, 2022 — Bayer AG today revealed the main endpoint was satisfied in 2 essential trials examining aflibercept 8 mg with 12- and 16-week dosing programs in clients with neovascular (damp) age-related macular degeneration (nAMD) and diabetic macular edema (DME) at week 48. The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME examined the non-inferiority of the 2 aflibercept 8 mg extended-dosing programs in regards to finest fixed visual skill (BCVA), compared to Eylea^® (aflibercept 2 mg) dosed every 8-week following preliminary month-to-month dosages. In these trials, the security of aflibercept 8 mg followed the reputable security profile of Eylea. Bayer will send these information to regulative authorities beyond the U.S.

“These innovative outcomes are exceptional news for clients. These results have actually revealed that aflibercept 8 mg not just enhanced vision with less regular injections, however likewise showed a comparable security profile to Eylea,” statedJean-François Korobelnik, Teacher of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial detective

“These essential aflibercept 8 mg trials showed that almost 90% of clients with diabetic macular edema and practically 80% of clients with damp age-related macular degeneration had the ability to keep a 16-week dosing program,” stated David Brown, M.D., FACS, Director of Research at Retina Consultants of Texas in the U.S. and a trial detective. “These unmatched toughness information combined with a security profile constant with that of Eylea assistance aflibercept 8 mg as a possible brand-new standard-of-care in these illness.”

Aflibercept 8 mg was examined in 2 double-masked, active-controlled critical trials– PULSAR (n=1009) in nAMD and PHOTON (n=658) in DME– to examine effectiveness and security compared to Eylea. Both trials were performed in numerous centers internationally with comparable styles and endpoints. At 48-weeks, both trials satisfied their main endpoints of non-inferiority of aflibercept 8 mg to Eylea. Extra outcomes were as follows:

In the aflibercept 8 mg 16-week dosing groups, 77% of nAMD clients in PULSAR (n=312) and 89% of DME clients in PHOTON (n=156) had the ability to preserve 16-week injection periods with approximately 5 injections in the very first year.

In the aflibercept 8 mg 12-week dosing groups, 79% of nAMD patie