Approximately one-third of the patients assigned to 16-week intervals of 8-mg formulation of Eylea changed to a 24-week interval during the second year of. the study, according results presented at the annual meeting of the American Academy of Ophthalmology. The PHOTON study enrolled people with diabetic macular edema.
A regimen of higher doses of Eylea (aflibercept) administered less often gained may gain traction with positive results reported from trials at the annual meeting of the American Academy of Ophthalmology (AAO) in San Francisco.
The FDA has aleady approved the 8-mg dose of Eylea, which is being marketed as Eylea HD. But that approval, which occurred in August 2023, was based on favorable results of the PULSAR and PHOTON studies at 48 weeks.The results reported at the AAO meeting were for outcomes after 96 weeks of treatment.
The PULSAR trial tested an 8-mg formulation of Eylea delivered at 12- and 16-week intervals in people with a neovascular, or “wet,” age-related macular degeneration. The PHOTON study was designed for the same purpose but in people with diabetic macular edema.
Eylea is a vascular endothelial growth factor inhibitor that is administered by intravitreal injection.
The 96-week results, which were presented on Friday, suggest that some patients could be treated with Eylea just two times a year (24-week intervals) and experience the same benefit as those treated every 12 and 16 weeks.
Less frequent dosing might translate into more prescriptions of Eylea HD and greater adherence.
In the PHOTON study, approximately one-third (32%) of those randomized to treatment every 16 weeks with the 8-mg dose had switched to a 24-week interval at the time that the last dosing interval was assigned and about one-quarter (24%) assigned treatment every 12 weeks had done so. There was a similar trend in the PULSAR study of significant minority of patients switching to longer intervals. In the PHOTON study, patients were eligible to switch to longer dosing intervals during the second year of the study if they had had less than five-letter loss in Best Corrected Visual Acuity (BCVA) since week 12 of their participation in the study and central retinal thickness of less than 300 microns. Reductions in central retinal thickness are often associated with improvements in BCVA and are widely used as measure of efficacy of retinal disease treatments.
The PHOTON trial has three arms: 167 patients randomized to receive the 2-mg formulation of Eylea every eight weeks, 328 patients randomized to receive the 8-mg formulation every 12 weeks and 163 patients assigned to receive the 8-mg formulation every 16 weeks. Results presented by Diana V. Do, a professor of ophthalmology and vice chair for clinical affairs at the Byers Eye Institute at Stanford University, on Friday showed a similar efficacy pattern for patients in all three groups: fairly steep improvement in the BCVA during the first 12 weeks followed by a leveling out over the next 84, and, similarly, a sharp decrease in central retinal thickness in the first 12 weeks and then a leveling out during the rest of the 96 weeks.
At the 96-week mark, the three groups ended up at about the same level in terms of BCVA improvement and decrease in central retinal thickness, although the 2-mg group with more frequent treatment fared slightly better when it came to BCVA, according to the data presented by Do. The 2-mg group gained 8.2 letters in BCVA while the 8-mg group that was assigned to get treated every 12 weeks gained 7.7 letters and the 8-mg randomized to the 16-week interval gained 6.6 letters.
The mean decrease in central retinal thickness for the 2-mg group was 191 microns. For the 8-mg group treated randomized to be treated every 12 weeks it was very similar: 194 microns. And for the 8-mg, 16-week-interval group, it was 158 microns.