Real-World Study Confirms Safety and Efficacy of Aflibercept Biosimilar Pavblu in 6,313 Patients
核心洞察
A large real-world study of 7,773 eyes from 6,313 patients treated with Pavblu (aflibercept-ayyh) showed stable vision outcomes with no unexpected safety concerns across 255 locations nationwide.
The biosimilar demonstrated comparable efficacy to reference aflibercept in a phase 3 trial of 579 patients with neovascular age-related macular degeneration (搜索), with 95.6% maintaining vision at week 52.
Only 0.01% of patients experienced serious eye infections (endophthalmitis (搜索)) and 0.09% had minor inflammation, confirming the biosimilar's safety profile matches the reference product.
A comprehensive real-world analysis of Pavblu (aflibercept-ayyh), a biosimilar to Eylea (aflibercept), has demonstrated stable vision outcomes and no unexpected safety concerns in over 6,000 patients treated across 255 locations nationwide. The findings, presented at the American Society of Retina Specialists (ASRS) annual meeting, provide crucial evidence for the biosimilar's performance in routine clinical practice.
Large-Scale Real-World Evidence
The retrospective case series analyzed 7,773 eyes of 6,313 patients treated by 302 retina specialists across the United States. Patients averaged nearly 80 years old, with 59% being female, and had an average visual acuity of roughly 20/66 at baseline. Among the 6,713 eyes previously treated with anti-VEGF (搜索) drugs, patients had received an average of six prior injections.
"New pharmacologic therapies may have effects that were not observed or anticipated in clinical research trials but that become apparent in clinical use," the researchers noted, emphasizing the importance of real-world data collection.
Over the study period, 11,036 injections of aflibercept-ayyh were administered. Vision levels remained stable after one, two, and three months of treatment, with no significant changes at any point. The safety profile proved reassuring, with only two eyes (0.01%) experiencing possible cases of endophthalmitis (搜索), a serious eye infection, and seven additional eyes (0.09%) developing minor inflammation that required no treatment changes.
Phase 3 Trial Confirms Clinical Comparability
Supporting the real-world findings, a multinational randomized phase 3 trial of 579 adults with treatment-naïve neovascular age-related macular degeneration (搜索) (nAMD) demonstrated comparable efficacy between ABP 938 (marketed as Pavblu) and reference aflibercept. The trial enrolled patients across 102 sites in 16 countries, with participants having a mean age of 76 years and 56% being women.
At week 8, patients treated with ABP 938 gained an average of 6.4 letters on the Early Treatment Diabetic Retinopathy (搜索) Study scale compared with 6.5 letters for those treated with aflibercept—a difference well within regulatory similarity margins. By week 52, 95.6% of patients who continued on ABP 938 maintained vision, compared to 97.6% for those continuing aflibercept and 95.9% for patients who transitioned from aflibercept to ABP 938.
Safety Profile Mirrors Reference Product
The phase 3 trial's safety findings aligned with the real-world data. Adverse events occurred in roughly 39% of ABP 938-treated patients and 37% of aflibercept-treated patients in the first 16 weeks, with most events being mild to moderate. The most common ocular adverse event was conjunctival hemorrhage. Six deaths occurred during the trial, but none were linked to study treatment.
"[Our] results showed ABP 938 has similar clinical efficacy, safety, and immunogenicity to aflibercept reference product in patients with neovascular age-related macular degeneration (搜索)," the study authors concluded.
Market Access and Clinical Impact
Pavblu received FDA approval in August 2024 as one of five aflibercept biosimilars to reach the U.S. market in 2024, joining Yesafil (aflibercept-jbvf), Opuviz (aflibercept-yszy), Ahzantiv (aflibercept-mrbb), and Enzeevu (aflibercept-abzv). As of May 2025, aflibercept-ayyh had secured national insurance coverage for approximately 80% of patients.
Dr. Carl Awh, a retina specialist with Tennessee Retina and consultant for Amgen, emphasized the value of the real-world data during his presentation. "Are there any unanticipated clinical outcomes associated with this new biosimilar? The answer comes through clinical experience," he stated.
The biosimilar addresses a significant market need, given that reference aflibercept generated $5.97 billion in U.S. sales and $9.5 billion worldwide. With its demonstrated safety and efficacy profile, Pavblu may play a critical role in expanding patient access to anti-VEGF (搜索) therapy while reducing healthcare spending for conditions including neovascular age-related macular degeneration (搜索), macular edema (搜索) after retinal vein occlusion, diabetic macular edema (搜索), and diabetic retinopathy (搜索).