Study Finds Pavblu Biosimilar Safe and Effective in Real-World Use | ASRS 2025

Patients who received Pavblu (aflibercept-ayyh), a biosimilar to Eylea (aflibercept), experienced no unexpected side effects and showed stable vision outcomes, according to findings presented at the American Society of Retina Specialists (ASRS) annual meeting this past weekend in Long Beach, Calif.

Pavblu was FDA approved in August 2024 as a biosimilar to Eylea, a drug commonly used to treat several serious eye conditions such as neovascular (wet) age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). Aflibercept-ayyh was approved after clinical trials involving between 350 and 600 patients showed that it was clinically equivalent to the reference product in terms of safety and effectiveness.

Pavblu, an Eylea biosimilar, shows stable vision outcomes and minimal side effects in real-world use, promising a reliable treatment option for patients. © Market Scope

With its approval, aflibercept-ayyh became one of five aflibercept biosimilars to reach the U.S. market in 2024, alongside 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.

The researchers’s shared goal of this new analysis was to determine if any unexpected outcomes occurred when the drug was used in routine clinical settings, outside of the smaller, controlled trials.

“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 in the study abstract.

By drawing on data from retina practices across the country, the study aimed to help both doctors and patients understand how the drug performs in the real world.

This was a retrospective case series involving 7,773 eyes of 6,313 patients treated by 302 retina specialists across 255 locations nationwide. Patients who had at least 28 days of follow-up after their first aflibercept-ayyh injection were only included. Data were collected from 27 practices using a shared electronic health record system. Researchers recorded patients’ demographics, diagnoses, vision levels and any new adverse events or signs of inflammation.

It was found that out of the 6,713 eyes that had previously been treated with anti-VEGF drugs, they averaged about six prior injections. On average, patients were nearly 80 years old, and 59% were female. At the beginning of the study, average visual acuity was roughly 20/66. After one, two and three months of treatment, vision levels remained stable—with no significant changes at any point.

Overall, 11,036 injections of aflibercept-ayyh were administered. Just two eyes (0.01%) experienced possible cases of endophthalmitis, a serious eye infection. Seven additional eyes (0.09%) had minor inflammation that did not require any changes in treatment. There were also no reports of more serious complications such as vasculitis, retinal detachment or newly diagnosed glaucoma.

Carl Awh, M.D., a retina specialist with Tennessee Retina and a consultant for Amgen, shared insights on the findings during a presentation.

“Are there any unanticipated clinical outcomes associated with this new biosimilar?” he asked. “The answer comes through clinical experience.”

Awh emphasized the value of having access to a wide network of retina specialists using a shared health record system, which allowed for a thorough review of real-world outcomes.

He also noted that most of the patients in this study had already been receiving treatment, so large improvements in vision were not expected. However, the fact that vision remained stable and no serious safety concerns were identified is a strong indicator that the biosimilar is a reliable and effective alternative to the original drug.

As more biosimilars enter the market, studies like this will be critical for confirming their safety and effectiveness outside of controlled trials.

The team behind this study shared plans to continue monitoring this drug and report any future findings, especially as more patients begin treatment and longer-term data become available.