On June 20, Novartis announced that both of its head-to-head pivotal Phase III trials of RTH258 (brolucizumab), HAWK and HARRIER, met the primary endpoint of non-inferior efficacy to Bayer/Regeneron’s Eylea in patients with neovascular age-related macular degeneration (nAMD).

The novel anti-vascular endothelial growth factor (anti-VEGF) treatment is designed to be administered by intravitreal (ITV) injection every 12 weeks, as opposed to the current lead treatment of AMD, Eylea (aflibercept), which is administered once every eight weeks. The two trials compared the mean change in best-corrected visual acuity (BCVA) from baseline to Week 48 of 6mg and 3mg RTH258 administered every 12 weeks weekly to 2mg Eylea administered every eight weeks. Both doses of RTH258 showed non-inferiority to Eylea.

Novartis concluded that RTH258 has the potential to address the needs of patients with nAMD for an efficacious treatment with a less frequent dosing regimen.

AMD is the leading cause of irreversible vision loss in developed countries, affecting millions of people worldwide. The disease causes a breakdown of the macula, a small area of the central retina, and as a result diminishes central vision, which severely impacts not only the patient’s quality of life but also that of their caregivers.  

There are two major forms of AMD: dry AMD and wet or nAMD. Patients who develop severe visual loss are mostly those with nAMD. Additionally, some dry AMD patients can convert to nAMD. In nAMD, new and fragile blood vessels, which are prone to leaking blood and fluid, aberrantly grow from the choroid layer into the macular layer of the retina, causing hemorrhage, fibrosis, degeneration of retinal tissues, and eventually blindness in the center of the vision.

The development and implementation of anti-VEGF drugs that are capable of stopping abnormal new blood vessel growth have greatly improved the prognosis for nAMD patients, measurably reducing the incidence of blindness in the elderly population. Based on their superior efficacy to a photodynamic therapy, Visudyne, which was used often before anti-VEGFs entered the market, anti-VEGFs have become the standard first-line therapy for the management of nAMD.

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Although the currently available anti-VEGFs are highly successful in halting disease progression and visual loss associated with nAMD, the effectiveness of this therapy can be hindered by under-dosing due to adherence issues. The elderly population typically has other health issues and problems; for these patients, adhering to strict scheduled treatment can be especially difficult. Missing doses of an anti-VEGF can lead to irreversible damage to the macula, resulting in further deterioration of vision and the need for more frequent ITV injections.

Lucentis was approved for wet AMD in the US in 2006 and maintained an impressive sales growth until the arrival of Eylea in 2011, which became the first choice of many physicians due to its less frequent administration—bi-monthly rather than monthly. As such, Eylea’s global sales have outperformed Lucentis’ in recent years.

Clearly, Eylea was an improvement on the previous standard-of-care VEGF inhibitor, Lucentis; however, key opinion leaders (KOLs) interviewed by GlobalData reported that in actual practice, injections of Eylea have been given more frequently, and therefore, the need for a treatment with a much longer duration of action still remains an unmet need for nAMD. GlobalData anticipates that Novartis’ longer-acting anti-VEGF, RTH258, has the potential to partially fulfil this need and become the standard of care in the nAMD space.