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Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Macular Edema;Retinal Vein Occlusion;Diabetic Retinopathy;Myopia, Degenerative;Diabetes Complications, Date of authorisation: 15/09/2023, Status: Authorised

The safety of Yesafili has been evaluated, and on the basis of the study carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Eylea.

For the complete list of side effects and restrictions of Yesafili, see the package leaflet.

The most common side effects with Yesafili (which may affect more than 1 in 20 people) include conjunctival haemorrhage (bleeding from the small blood vessels on the surface of the eye at the site of injection), retinal haemorrhage (bleeding at the back of the eye), reduced vision, eye pain, vitreous detachment (detachment of the jelly-like substance inside the eye), cataract (clouding of the lens), vitreous floaters (small, dark shapes moving in the field of vision) and increased intraocular pressure (increased pressure inside the eye).

Serious injection-related side effects (which have occurred in less than 1 in around 2,000 injections in studies) include blindness, endophthalmitis (inflammation inside the eye), cataracts, increased intraocular pressure, vitreous haemorrhage (bleeding into the jelly-like fluid in the eye, causing temporary loss of vision) and vitreous or retinal detachment (retina is pulled away from the normal position at the back of the eye).

Yesafili must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes), or in patients who have severe inflammation inside the eye.

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