Human medicines European public assessment report (EPAR): Vislyfa, ranibizumab, Status: Opinion

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

On 21 May 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vislyfa, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation.

The applicant for this medicinal product is Lupin Europe GmbH.

Vislyfa will be available as a 10 mg/ml solution for injection. The active substance of Vislyfa is ranibizumab, an antineovascularisation agent (ATC code: S01LA04). Ranibizumab is a monoclonal antibody fragment which modulates angiogenesis by inhibiting vascular endothelial growth factor A.

Vislyfa is a biosimilar medicinal product. It is highly similar to the reference product Lucentis (ranibizumab), which was authorised in the EU on 22/01/2007. Data show that Vislyfa has comparable quality, safety and efficacy to Lucentis.

The full indication is:

Vislyfa is indicated in adults for:

• The treatment of neovascular (wet) age-related macular degeneration (AMD)
• The treatment of visual impairment due to diabetic macular oedema (DME)
• The treatment of proliferative diabetic retinopathy (PDR)
• The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
• The treatment of visual impairment due to choroidal neovascularisation (CNV).

Vislyfa must be administered by a qualified ophthalmologist experienced in intravitreal injections.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Vislyfa

Adopted

Reference Number:

EMADOC-1829012207-52030

English (EN) (148 KB - PDF)

First published:

22/05/2026

View

Product details

Name of medicine

Vislyfa

Active substance

ranibizumab

International non-proprietary name (INN) or common name

ranibizumab

Therapeutic area (MeSH)

• Wet Macular Degeneration
• Macular Edema
• Diabetes Complications
• Retinal Vein Occlusion
• Choroidal Neovascularization

Anatomical therapeutic chemical (ATC) code

S01LA04

EMA product number

EMEA/H/C/006926

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation applicant

Lupin Europe GmbH

Opinion adopted

21/05/2026

Opinion status

Positive

News on Vislyfa

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026

22/05/2026

This page was last updated on

22/05/2026