At AAO 2023, Korobelnik provides insight into the efficacy and safety of aflibercept 8 mg in patients with nAMD observed over 2 years of the PULSAR study.
New 96-week results from the phase 3 PULSAR study revealed aflibercept 8 mg provided improvements in anatomical and functional outcomes, compared to the standard, 2 mg dosage, for patients with neovascular age-related macular degeneration (nAMD).
Presented at the 127th Annual American Academy of Ophthalmology (AAO) Meeting in San Francisco, California, the findings showed interval extension between aflibercept 8 mg injections at a maximum of 24 weeks. According to the data, more than 80% of patients extended to every-12-week (Q12W) or longer and approximately 30% of patients were able to reach every-24-week (Q24W) dosing.
“This is extremely interesting and a very, very good result for the 8 mg aflibercept,” said Jean-Francois Korobelnik, MD, PhD, head of the department of ophthalmology at Bordeaux University Hospital, in an interview with HCPLive at AAO 2023.
The PULSAR study was a randomized, multicenter, double-masked pivotal trial of ≥1,000 patients which compared aflibercept 2 mg every 6 weeks (Q6W), aflibercept 8 mg every 12 weeks (Q12W), and aflibercept 8 mg every 16 weeks (Q16W). The primary endpoint was at 1 year and included the option for a second-year extension. Approximately 85% of patients remained in the trial at the 2-year mark.
Safety outcomes related to the aflibercept 8 mg dose revealed no specific intraocular inflammation, no vasculitis, and systemically no elevated blood pressure. Korobelnik noted “it looks as safe as the 2 mg dose.”
Korobelnik stressed the importance of treatment durability and lowering the number of visits and treatments for elderly nAMD patients, who often experience challenges with transportation and attendance to the appointments.
“Anything that can lower the burden by expanding the interval between the injections is good for those categories of patients,” Korobelnik said. “And that's what we get with aflibercept 8 mg.”
For more insight into the 96-week PULSAR results, watch the full interview with Korobelnik in the above video.