Aflibercept 8 mg: The Breakthrough That Allows 89% of Patients to Extend Injection Intervals to 16 weeks

Great news for patients today as Bayer AG has revealed that the main endpoint was satisfied in two critical 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 assessed the non-inferiority of the two aflibercept 8 mg extended-dosing programs in regards to finest remedied visual skill (BCVA), compared to Eylea ® (aflibercept 2 mg) dosed every 8-week following initial monthly doses. In these trials, the security of aflibercept 8 mg followed the reputable security profile of Eylea. Bayer will send these information to regulatory authorities beyond the U.S.

“These revolutionary outcomes are excellent news for patients,” said Jean-François Korobelnik, Teacher of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial detective. “These results have actually revealed that aflibercept 8 mg not only improved vision with fewer, less frequent injections, but also showed a comparable security profile to Eylea.”

“These critical aflibercept 8 mg trials showed that almost 90% of clients with diabetic macular edema and nearly 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 extraordinary sturdiness data paired with a security profile consistent with that of Eylea support aflibercept 8 mg as a potential new standard-of-care in these diseases.”

Aflibercept 8 mg was examined in two double-masked, active-controlled critical trials– PULSAR (n=1009) in nAMD and PHOTON (n=658) in DME– to assess effectiveness and security compared to Eylea. Both trials were conducted in numerous centers internationally with comparable designs and endpoints. At 48-weeks, both trials satisfied their main endpoints of non-inferiority of aflibercept 8 mg to Eylea. Additional 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 keep 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 clients in PULSAR (n=316) and 91% of DME clients in PHOTON (n=300) had the ability to maintain 12-week injection periods with approximately 6 injections in the first year.

In a pooled analysis of aflibercept 8 mg dosing groups, 83% of nAMD clients in PULSAR and 93% of DME clients in PHOTON kept 12-week dosing or longer.

The security of aflibercept 8 mg in both trials was similar to the reputable security profile of Eylea and consistent with the security of Eylea observed in previous medical trials. Comparing aflibercept 8 mg to Eylea, the rates of major ocular adverse events were 1.6% versus 0.6% in PULSAR and 0.6% versus 0.6% in PHOTON.

» …
Read More

Latest articles

Related articles