The Phase 3 PULSAR trial demonstrated that aflibercept 8 mg provides greater therapeutic benefits and an extended injection interval, with equivalent safety, compared to aflibercept 2 mg in the treatment of neovascular age-related macular degeneration (nAMD), according to data presented at ASRS 2023.
The ongoing trial aims to evaluate the efficacy and safety of intravitreal aflibercept 8 mg injections administered every 12 (8q12) or 16 weeks (8q16) versus aflibercept 2 mg injections every 8 weeks (2q8) after an initial 3-month monthly treatment. A total of 1009 patients aged ≥50 years with nAMD, were randomly divided into 3 groups: 8q12, 8q16, and 2q8.
The results demonstrated that aflibercept 8 mg met the primary efficacy endpoint, showing non-inferiority in best-corrected visual acuity (BCVA) compared to aflibercept 2 mg from baseline at Week 48. Patients who received the 8 mg injections every 12 or 16 weeks exhibited significant visual acuity improvements. The observed mean change from baseline in BCVA at Week 48 was +6.7 letters for 8q12, +6.2 letters for 8q16, and +7.6 letters for 2q8.
The study found that a majority of patients receiving the 8 mg injections maintained extended dosing intervals of at least 12 weeks (83% in the combined 8 mg groups) and 16 weeks (77% in 8q16) throughout the first year.
Additionally, the trial showed that aflibercept 8 mg demonstrated superior drying effects compared to aflibercept 2 mg at Week 16. In the 8 mg group, 63% of patients had no intraretinal/subretinal fluid in the central subfield, while only 52% of patients in the 2 mg group experienced the same outcome.
Reference
Patel J. Intravitreal Aflibercept 8 mg Injection in Patients With Neovascular Age-Related Macular Degeneration: 48-week Results From the Phase 3 PULSAR Trial. Presented at: ASRS 41st Annual Meeting.
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