The primary endpoints in two clinical trials investigating drug aflibercept 8 mg with 12 and 16-week dosing regimes, for patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD), have been met.
The trials, called PHOTON in DME and PULSAR in wAMD, both showed the dosing regimens achieved non-inferiority in vision gains compared to the Eylea 8-week dosing regimen.
In these trials, the safety of aflibercept 8 mg was consistent with the established safety profile of Eylea. Regeneron and Bayer will submit these data to regulatory authorities in countries around the world.
Unprecedented durability data for Aflibercept
Trial investigator and director of research at Retina Consultants, David Brown, said: “These pivotal aflibercept 8 mg trials demonstrated that nearly 90% of patients with diabetic macular edema and almost 80% of patients with wet age-related macular degeneration were able to maintain a 16-week dosing regimen.
“These unprecedented durability data coupled with a safety profile consistent with that of Eylea support aflibercept 8 mg as a potential new standard-of-care in these diseases.”
PHOTON and PULSAR are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally.
Jean-François Korobelnik, professor of ophthalmology at University Hospital of Bordeaux, France, said: “These groundbreaking results are excellent news for patients. These outcomes have shown that aflibercept 8 mg not only improved vision with less frequent injections, but also demonstrated a similar safety profile to EYLEA.”
Well-established safety profile
The safety of aflibercept 8 mg was similar to Eylea in both trials, and consistent with the well-established safety profile of the drug from previous clinical trials. In both trials, there were no new safety signals for aflibercept 8 mg and Eylea, and no cases of retinal vasculitis, occlusive retinitis or endophthalmitis.
Principal inventor of aflibercept, George Yancopoulos, said: “Over the last decade, Eylea has become the standard-of-care for diabetic macular edema and wet age-related macular degeneration.
“The results of these trials with our novel aflibercept 8 mg formulation demonstrated that a remarkably high percentage of patients were maintained on 12- and 16-week dosing intervals through week 48, suggesting aflibercept 8 mg has the potential to be as paradigm-changing as Eylea.”
In the U.S., Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of Eylea.
Aflibercept 8 mg is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.
In both PHOTON and PULSAR, patients with DME and wAMD were randomized into three treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or Eylea every 8 weeks.
Patients treated with aflibercept 8 mg in both trials had three initial monthly doses, and patients treated with Eylea received five initial monthly doses in PHOTON and 3 in PULSAR.
In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression was observed.
Intervals could not be extended until the second year of the study, with those results still to be assessed. Patients in all Eylea groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.
The lead sponsors of the trials were Regeneron for PHOTON and Bayer for PULSAR.