Aflibercept-ayyh (aflibercept 2 mg biosimilar) for treatment-naïve retinal vascular diseases: early real-world experience - the APEX study.

PURPOSE: To evaluate the early real-world efficacy of intravitreal aflibercept 2 mg biosimilar (aflibercept-ayyh, Pavblu, Amgen, USA.) across common retinal vascular diseases in treatment-naïve eyes.

METHODS

This retrospective, observational study was conducted at The Retina Service of Wills Eye Hospital (Mid Atlantic Retina, Philadelphia, PA, USA.) and included treatment-naïve eyes with retinal vascular diseases treated with aflibercept-ayyh in a real-world clinical setting. Functional and anatomical changes from baseline to last follow-up were analyzed using paired t-tests and Wilcoxon signed-rank tests.

RESULTS

A total of 707 eyes (1,912 injections) were analyzed over a mean follow-up of 8.5 ± 6.5 weeks (2.7 ± 1.4 injections). Mean BCVA improved from 0.68 to 0.60 logMAR (+3.8 ETDRS letters, p < 0.001), and mean CFT decreased from 331.9 µm to 232.6 µm (-99.3 µm, p < 0.001). IRF decreased from 50.1% to 23.5%, SRF from 26.3% to 6.2%, and sub-RPE/PED fluid from 39.5% to 31.3%. CRVO and BRVO showed the greatest improvements. No intraocular inflammation, vascular occlusion, endophthalmitis, or systemic adverse events occurred; cataract progression was observed in 0.7% of eyes.

CONCLUSION

Aflibercept-ayyh demonstrated significant early visual and anatomical improvements across major retinal vascular diseases with a favorable short-term safety profile.