The European Medicines Agency (EMA) has announced its approval of two new biosimilar medications, Afqlir and Opuviz, to treat age-related macular degeneration (ARMD). The active ingredient of both agents is aflibercept that received an identical positive opinion recommending granting marketing authorization for the treatment of neovascular age-related macular degeneration, visual impairment due to macular edema secondary to branch and also due to diabetic macular edema, furthermore central retinal vein occlusion.
The EMA constated that both Afqlir and Opuviz had quality, safety, and efficacy comparable with Eylea, which had been used as the reference product. Both new drugs will be available as a 40-mg/mL solution for injection. Both authorizations stipulate that the agent must be administered by a qualified physician experienced in giving intravitreal injections.
The recommended dose for Eylea is 2 mg aflibercept, equivalent to 0.05 mL. The drug is initiated with one injection per month for three consecutive doses. After this, the treatment interval is extended to 2 months and may be maintained or further extended on the basis of the treating clinician’s judgment to maintain stable visual and/or anatomic outcomes. If outcomes deteriorate, the treatment interval should be shortened accordingly.
