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Experts share how aflibercept 8 mg could reshape clinical practice
During the 16th Annual Congress on Controversies in Ophthalmology (CoPHY 2025), held in Seville, Spain on April 5, four retinal specialists shared recent findings on aflibercept 8 mg.
Experts presented evidence from the PULSAR1 and PHOTON2 extension studies, which compared the efficacy and safety of 8 mg aflibercept versus 2 mg aflibercept through year 3 in treatment-naive patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The studies showed that patients receiving 8 mg aflibercept maintained improved visual and anatomic results with longer treatment intervals and fewer injections than patients receiving 2 mg aflibercept.1,2
The latest with aflibercept 8mg
“Aflibercept 8 mg provides what we hoped for: Next-generation precision, simplicity and efficiency,” said Prof. Anat Loewenstein (Israel). “It has an innovative pre-set mechanical dose designed to deliver exactly 70 µl of aflibercept 8 mg … providing the trust that patients are getting a precise dose every time.”
Patients receiving aflibercept 8 mg are also getting fewer injections. Prof. Loewenstein noted that the PULSAR extension, which included patients who switched from 2q8 to 8q12 at week 96, demonstrated that meaningful vision gains and robust central retinal thickness (CRT) reductions were sustained. “This is excellent and really shows that 8 mg [aflibercept] provides longer duration,” she said.
The safety profile of aflibercept 8 mg also continued to be favorable with no new signals reported.
The PHOTON extension study also included patients who switched from 2q8 to 8q12 at week 96.
Better, faster drying where it matters
Prof. Paolo Lanzetta (Italy) provided key insight into the drying ability of aflibercept 8 mg versus 2 mg in nAMD and DME patients.
Aflibercept 8 mg for nAMD
The PULSAR extension showed aflibercept 8 mg had a faster time to fluid-free status versus 2 mg. “There was a median time of eight weeks for 2 mg versus four weeks for 8q12 and 8q16 dosing,” he said.
The durability of aflibercept 8 mg also delivers inspiring outcomes. “Fluid control has been obtained with only 12.7 injections on average for the 8 mg patients, and this could also be obtained in a certain group of patients with as few as four injections in the third year. This is very notable,” said Prof. Lanzetta.
Aflibercept 8 mg for DME
Meanwhile, the PHOTON post hoc analysis showed that 8 mg aflibercept provided a better drying effect than 2 mg with better fluid control, even in eyes with more severe disease.
There were numerical CRT differences when comparing patients who received three loading doses at 8 mg with those who received five loading doses at 2 mg. The 2 mg group showed a 55.6 µm increase in CRT, whereas the 8 mg had more manageable outcomes: At q12 there was a 3.5 µm increase, and at q16 there was an increase of 5.7 µm.
The PHOTON extension showed that a greater proportion of patients with DME achieved a fluid-free foveal center after switching from aflibercept 2 mg to 8 mg. “In the first year, 53% of patients on 2 mg were without fluid in the foveal center at week 48. At week 96, 76% of 2 mg patients were fluid free. They then began treatment with 8 mg and there was further improvement in terms of patients without fluid in the foveal center: 86%, 83% and 83% at 100 weeks, 104 weeks and 156 weeks, respectively.”
“We also see a mean change in CRT from baseline,” Prof. Lanzetta said. “The 2 mg patients were treated with 8 mg at week 96, and after a single injection of 8 mg there was a CRT reduction of 54 µm – which was much better than anything noted in the first two years with 2 mg.”
“And if you continue following the patients, you see that compared with the first two years of treatment with aflibercept 2q8, fluid reaccumulation was slower eight weeks after the first dose of aflibercept 8 mg,” added Prof. Lanzetta. “It’s also notable that after receiving the 8 mg dose at week 96, patients also enter a q12 regimen. When you move the patients to 8 mg, you have some further decreases in CRT: -197.4 at week 156 versus -169.7 at week 96 at 2 mg.”
A clear choice for treatment-naive patients
Dr. David Brown (USA) explained why it’s best to start treatment-naive patients on aflibercept 8 mg: “In our field, it’s about compliance and the number of visits, and the ability of the healthcare delivery system to take care of the population.”
He then shared a case detailing a treatment-naive patient with nAMD: A 99-year-old female with 20/60 BCVA with new onset nAMD in her better seeing eye.
“We gave her one dose of aflibercept 8 mg and she had a nice response, her fluid is all gone. We gave her another dose and she’s absolutely dry. After her loading doses, she went straight to 12 weeks,” said Dr. Brown.
He added that aflibercept 8 mg is also a clear choice for previously treated patients, too. In the case of an 88-year-old male with nAMD, the patient was unable to extend beyond 8 weeks on aflibercept 2 mg without recurrent fluid. So, Dr. Brown switched him to faricimab; however, there was new activity at 8 weeks and he didn’t do any better than he did on 2 mg aflibercept.
“We were at ~7 weeks, then every time we tried to go to 8, he recurred fluid. So, we switched him to aflibercept 8 mg and we maintained 8 week intervals, then 12 weeks, and finally extended to 14 weeks. This is a great case that shows how 8 mg aflibercept is really helpful in extending intervals,” explained Dr. Brown. [Disclaimer: Patient outcomes may vary.]
Longer treatment intervals could reshape future practice
According to Dr. Patricia Udaondo (Spain), aflibercept 8 mg aims to future-proof clinical practice by reducing treatment burden and facilitating simple and flexible administration. “We have the opportunity to have three loading doses for both nAMD and DME – and for the first time, we have the opportunity to extend to 20 weeks.
For patients, extended treatment intervals with meaningful vision gains means more time for work and leisure, more independence and reduced stress associated with treatment and improved quality of life. It also provides caregivers with more time for work and leisure, reduced travel to and from appointments and fewer clinic visits.
For clinics, it means a reduced number of visits, leading to an increased clinic capacity and reduced costs. “Data suggest that aflibercept 8 mg would be the anti-VEGF that generates the lowest per patient healthcare cost over three years, thanks to the lower injection frequency and reduced number of discontinued treatments.”
“Finally, we have the new prefilled syringe which is completely different and easy to use. It offers simplified and precise dosing. You just have to push, twist and inject. It’s also environmentally friendly with a 40% reduced size of blister and folding box,” she said.
Editor’s Note: Reporting for this story took place at the 16th Annual Congress on Controversies in Ophthalmology (CoPHY 2025), held in Seville, Spain on April 5.
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References
- Lanzetta P, Korobelnik JF, Heier JS, et al; PULSAR Investigators. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024;403(10432):1141-1152.
- Brown DM, Boyer DS, Do DV, et al; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024;403(10432):1153-1163.