Regeneron Pharmaceuticals has reported that its experimental 8mg dose of aflibercept met the primary safety goal of the proof-of-concept Phase II clinical trial in wet age-related macular degeneration (wet AMD) patients.

The 8mg aflibercept is being co-developed by Regeneron and Bayer.

The ongoing randomised, single-masked Phase II trial enrolled a total of 106 treatment-naïve wet AMD patients aged 50 years or above.

It analysed the safety, efficacy and tolerability of 8mg aflibercept compared with the currently approved dose of 2mg aflibercept injection, which is marketed as Eylea.

Subjects were categorised to receive three initial injections of either dose on weeks zero, four and eight, before the primary goal assessment at week 16.

After the assessment, the dosing was expanded to every 12 weeks or more often, if needed, because of the persistence or progression of the disease.

The drug’s efficacy was evaluated based on the retinal fluid presence in the centre subfield on optical coherence tomography (OCT) at this time point.

The encouraging top-line data showed that no new safety signals linked to 8mg aflibercept were reported in the trial when compared to 2mg Eylea.

Furthermore, an increased proportion of 43.4% of subjects in the 8mg aflibercept arm had no retinal fluid versus 26.4% in the 2mg Eylea arm at week 16, meeting the primary efficacy goal.

In the trial, adverse events (AEs) were reported in 17% of subjects receiving 8mg aflibercept versus 22.6% in the 2mg Eylea group.

Two serious ocular AE cases were observed in the trial, one each in the 8mg aflibercept group and 2mg Eylea arm.

Regeneron noted the trial will continue through week 44.

At present, 8mg aflibercept is being analysed in two large Phase III trials in wet AMD and diabetic macular oedema (DME) patients, with results anticipated in the second half of next year.

For these trials, which are evaluating the safety and efficacy of 8mg aflibercept for up to two years, visual acuity is the primary efficacy goal at 48 weeks.

Regeneron Pharmaceuticals president and chief scientific officer George Yancopoulos said: “We are cautiously optimistic that these early data suggest that a higher dose of aflibercept may potentially benefit patients with wet AMD, and we look forward to Phase III data next year, which will be crucial to understand its overall efficacy and safety.

“Having worked for nearly two decades in retinal disease, we know that large, robust data sets are required to fully understand whether a medicine can achieve three critical things: improved visual and anatomic outcomes, convenient dosing, and a safety profile that is consistent with Eylea.”

In March 2021, Regeneron reported initial results from the Protocol W trial of Eylea (aflibercept) injection, which showed a 68% reduced risk of developing vision-threatening complications in patients with moderate to severe non-proliferative diabetic retinopathy, without centre-involved diabetic macular oedema.