Ranibizumab Biosimilar for Age-related Macular Degeneration

Clobetasol propionate ophthalmic nanoemulsion is in development for the treatment of post-operative pain or inflammation following cataract surgery. A cataract is a cloudy area in the lens, which can develop slowly and progress to general loss of transparency, which may lead to functional impairment and visual deterioration. Cataract surgery is the only effective treatment to improve or maintain vision, however, inflammation and pain are common difficulties following this treatment.

Ranibizumab is a type of antibody that is targeted against a particular protein. Ranibizumab has been designed to attach to and block a substance called vascular endothelial growth factor A (VEGF-A). VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula (the central part of the retina). By blocking VEGF-A, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling. The port delivery system (PDS) will include a device which is permanently surgically implanted in the eye and filled with a special formulation of ranibizumab; this will reduce the amount of hospital visits required and reduce the burden of repeat intravitreal injections. If licensed, this technology will provide an additional treatment option for patients with nAMD.

Faricimab is an antibody given by intravitreal injection that binds to both VEGF-A and angiopoietin-2 which results in blood vessels becoming more stable, leaking less blood and fluid and reduced inflammation. Faricimab has been shown in clinical trials to have an extended durability compared to other anti-VEGF agents so fewer injections will be required. If licensed, faricimab will offer an additional treatment option for patients with neovascular AMD.

Brolucizumab is in clinical development for the treatment of visual impairment due to diabetic macular oedema (DMO). DMO is a condition affecting the retina, the nerve layer at the back of the eye. The central part of the retina known as the macula, is responsible for fine detail vision, both for near (reading) and for distance. In patients with DMO, the fine meshwork of blood vessels supplying nutrients and oxygen to the macula become damaged and leaky due to the high levels of glucose in the bloodstream in some patients with diabetes. If left untreated, the leakage will potentially permanently damage the retinal nerve cells and eventually produce scarring, which can be irreversible.