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Regeneron presents positive results from aflibercept 8 mg in patients with diabetic macular edema & wAMD at AAO meeting

Tarrytown, New York
Monday, October 3, 2022, 15:00 Hrs  [IST]

Regeneron Pharmaceuticals, Inc. announced the first presentations of positive detailed results from two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens, compared to Eylea (aflibercept) injection, in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD).

The data were presented in a late-breaking session at the American Academy of Ophthalmology (AAO) annual meeting in Chicago and will support the submission of a new Biologics License Application to the US Food and Drug Administration by early 2023.

"Our presentations at AAO demonstrate that aflibercept 8 mg 12- and 16-week dosing regimens have achieved a high bar, sustaining improvements in visual acuity and anatomic measures of retinal fluid across 48 weeks in patients with diabetic macular edema and wet age-related macular degeneration," said George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron, and a principal inventor of aflibercept. "These results were all achieved in patients who were rapidly initiated on extended dosing intervals with the vast majority not requiring regimen modification. Altogether, the pivotal data support aflibercept 8 mg as providing a longer duration of action while maintaining a safety profile similar to Eylea."

As presented at AAO, the PHOTON trial in DME and the PULSAR trial in wAMD both met the same primary endpoint. Aflibercept 8 mg demonstrated non-inferiority in vision gains in both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to an Eylea 8-week dosing regimen. Furthermore, 91% and 89% of DME patients and 79% and 77% of wAMD patients respectively randomized to 12- and 16-week dosing maintained those intervals through 48 weeks. The safety of aflibercept 8 mg was similar to Eylea in both trials, and consistent with the known safety profile of Eylea from previous clinical trials. Comparing aflibercept 8 mg to Eylea, ocular adverse events occurred in 31% versus 28% in PHOTON and 38% versus 39% in PULSAR, and there were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in either trial.

Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. In the US, Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the US, 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.

PHOTON in DME (N=658) and PULSAR in wAMD (N=1,009) are double-masked, active-controlled pivotal trials that are being conducted in multiple centres globally. In both trials, patients were randomized into 3 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 3 initial monthly doses, and patients treated with Eylea received 5 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 were 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.

DME is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Of the nearly 28 million American adults living with diabetes, an estimated 1.2 million have DME.

wAMD is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. An estimated 1.1 million Americans have wAMD, and this number is expected to double by 2050.


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