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Aflibercept 8mg could become AMD standard-of-care after pivotal trial

The drug company that produces Eylea (2 mg aflibercept) has announced clinical trial results showing the anti-VEGF therapy can be delivered at a higher doses at longer intervals, with a similar safety profile.

“These pivotal aflibercept 8 mg trials demonstrated that nearly 90% of patients with diabetic macular edema (DME) and almost 80% of patients with wet age-related macular degeneration (wAMD) were able to maintain a 16-week dosing regimen,” said Dr David Brown, director of research at Retina Consultants of Texas in the US and a trial investigator.

“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.”

On 8 September, Regeneron Pharmaceuticals and Bayer announced the primary endpoints were met in two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with DME and wAMD.

These were compared against an Eylea (2mg aflibercept) eight-week dosing regimen.

The PHOTON trial in DME and the PULSAR trial in wAMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the Eylea group.

In these trials, the manufacturer reported the safety of aflibercept 8 mg was consistent with the established safety profile of Eylea. Regeneron and Bayer said they would now submit these data to regulatory authorities in countries around the world.

“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,” said Dr Jean-François Korobelnik, Professor of Ophthalmology and head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial investigator.

PHOTON (N=658) and PULSAR (N=1,009) are double-masked, active-controlled pivotal trials that are being conducted in multiple centres globally. At 48 weeks, >90% of patients in all dosing groups in both trials completed the treatment period.

In both trials, Regeneron/Bayer said there were no new safety signals for aflibercept 8 mg and Eylea, and no cases of retinal vasculitis, occlusive retinitis or endophthalmitis.

“Over the last decade, Eylea has become the standard-of-care for diabetic macular edema and wet age-related macular degeneration,” said Dr George D. Yancopoulos, president and chief scientific officer at Regeneron, and a principal inventor of aflibercept.

“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.”

Detailed efficacy and safety data from PHOTON and PULSAR are planned for presentation at an upcoming medical meeting.

Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. 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.

More information and data can be found here.

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