Swiss pharmaceutical firm Novartis has secured the European Commission (EC) approval for its Beovu (brolucizumab) injection to treat wet age-related macular degeneration (AMD).

Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that induces growth of abnormal blood vessels underneath macula, an area of the retina that controls central vision.

The fragile blood vessels would leak fluid, and disrupt the normal retinal architecture, causing damage to the macula, leading to severe vision loss and blindness.

Novartis Pharmaceuticals president Marie-France Tschudin said: “Currently, wet AMD patients, who are often older, can face significant challenges in managing their disease.

“We believe that Beovu, and its ability to resolve fluid, brings great therapeutic value that will help physicians optimize treatments for patients based on disease activity. With the approval of this innovative biologic, Novartis is continuing to reimagine medicine for people living with wet AMD.”

Beovu inhibits activation of VEGF receptors by preventing the ligand-receptor interaction

Beovu, also known as RTH258, is a clinically advanced humanised single-chain antibody fragment (scFv), which inhibits activation of VEGF receptors by preventing the ligand-receptor interaction.

Inhibition of VEGF pathway is said to prevent the growth of neovascular lesions, stop the proliferation of endothelial cells along with vascular permeability, said the company.

The EC approval is supported by the results from the Phase III HAWK and HARRIER clinical trials, in which Beovu has reached the primary and secondary endpoints.

Novartis claimed that Beovu marks the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a marker of disease activity, compared to the aflibercept.

In addition, the EC approval is applicable to all the 27 member states in the European Union, along with the UK, Iceland, Norway and Liechtenstein.

University of Bonn department of ophthalmology professor and chairman Frank Holz said: “Drying the retina is one of the main goals in the treatment of wet AMD with anti-VEGF therapy.

“Beovu, with its superior fluid resolution as demonstrated in the HAWK and HARRIER trials, will provide physicians with a new option to treat wet AMD.”