Regeneron Pharmaceuticals has just announced the results from their Phase 2 trial of aflibercept. The trial aimed to compare an 8mg dose of the treatment to a 2mg dose, which is already approved for patients diagnosed with wet age-related macular degeneration (wet AMD or wAMD).

Researchers believe that the higher dose of aflibercept could minimize how frequently patients need the treatment while maintaining the same safety and efficacy they experience with the small dose.

Phase 2 Trial

This Phase 2 clinical trial was called CANDELA. It included 106 patients who had never received another treatment. Patients were 77 years old on average and had an average retinal thickness of 502.1 microns at baseline. Additionally, their BCVA ETDRS score was 59 on average.

All participants were randomized to either receive 8mg or 2mg of Eylea. Both groups of patients received 3 injections of their respective therapies at week 0, week 4, and week 8. The primary endpoint of the trial (presence of retinal fluid in the center subfield) was investigated at week 16, and then dosing was extended to occur every 12 weeks. Some patients had more frequent dosing if they experienced disease progression.

Results

Researchers found that a greater number of patients reached the primary endpoint in the 8 mg group than in the 2 mg group. At week 16, 43% of the patients in the 8 mg group had no fluid within their macula while 26% of patients in the 2 mg group didn’t have fluid. Measurements of fluid in the center subfield were similar, with 51% of patients having no fluid in the 8 mg group and 34% of patients having no fluid in the 2 mg group.

Participants in the 8 mg group showed more improvements in their vision all the way through week 44 of treatment. At every timepoint that researchers measured, the 8 mg group’s eyes were more likely to be dry.

Additionally, the 8 mg group had a 7.9 letter improvement on average at week 44. The 2 mg group had an improvement of just 5.1 letters on average. Further, 47% of patients in the 8 mg group had a minimum of a 10 letter gain and 28% had a gain of over 15 letters. These numbers were just 35% and 18% in the 2 mg group, respectively.

38% of patients in both groups experienced an adverse event, but there weren’t any serious adverse events documented. The common AEs in the 8 mg group were conjunctival hemorrhage, vitreous detachment, and retinal tear.

Phase 3 Clinical Trials

Next, a Phase 2/3 trial will begin in diabetic macular edema. This trial is called PHOTON. It will be a randomized, multi-center trial which will continue to investigate the safety and efficacy of the higher dose.

Additionally, there will be a Phase 3 clinical trial for wet AMD called PULSAR. This trial will also be randomized and multi-center. 

You can read more about these ongoing clinical trials here.