
EMA approves Pavblu (aflibercept-ayyh) a biosimilar to Eylea for wet age-related macular degeneration (AMD), diabetic macular edema, and retinal vein occlusions.- Amgen
The European Medicines Agency (EMA) has officially authorized Pavblu,(aflibercept-ayyh) a biosimilar to Eylea, expanding treatment options for adults suffering from various vision impairments. This approval marks a significant advancement in managing conditions like wet age-related macular degeneration (AMD), diabetic macular edema, and retinal vein occlusions. Pavblu is prescribed for adults dealing with the wet form of AMD, characterized by abnormal blood vessel growth beneath the macula, leading to impaired vision. Additionally, it addresses macular edema resulting from central or branch retinal vein occlusions, diabetic complications, and myopic choroidal neovascularization. Administered through intravitreal injections, Pavblu requires careful handling by experienced healthcare professionals to ensure efficacy and patient safety.
Clinical studies indicate that Pavblu’s safety profile mirrors that of its reference medicine, Eylea. Common side effects include conjunctival hemorrhage, retinal hemorrhage, reduced vision, and eye pain. While most adverse effects are mild to moderate, serious risks such as endophthalmitis and retinal detachment, though rare, necessitate vigilant monitoring by patients and healthcare providers.