A new investigational drug for AMD may require fewer doses than those already marketed
Need for a New Drug for Age-Related Macular Degeneration (AMD)
Convenience of administration of drugs is an important factor for patients with age-related macular degeneration (AMD), a disease that causes gradual loss of sight due to blurring or loss of central vision in people over age 60 and is the leading cause of severe vision loss and legal blindness in North America, Europe, Australia and Asia, impacting an estimated 20 to 25 million people worldwide. The intravitreal injections which needs to be taken every month in case of some of the approved drugs (anti-VEGF treatments that have been shown to slow disease progression) are usually followed by foggy vision with difficulty to perform everyday tasks. A new investigational drug, brolucizumab (or RTH258) may provide relief to these patients as per results from a recent phase 3 trial which shows similar efficacy with less frequent dosing schedule than already marketed drugs.
Efficacy of brolucizumab
Novartis, who is currently developing this drug, reported that brolucizumab, 3 and 6 mg, met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. These studies enrolled more than 1800 neovascular AMD patients and checked non-inferiority to Eylea (marketed by Regeneron Pharmaceuticals) in mean change in best-corrected visual acuity (BCVA) from baseline to week 48, and average mean change over the period of week 36-48, respectively. It was found to be as effective as Eylea, even with dosing schedule of once in every three months, versus monthly or every two months for Regeneron’s drug in more than half of the patients. The drug was also found to be well tolerated with overall ocular and non-ocular (systemic) adverse event rates comparable to Eylea.
Like both it’s rivals Eylea and Lucentis (marketed by Roche), brolucizumab is a protein based inhibitor of VEGF. By inhibiting the function of circulating VEGFs in blood, it inhibits the growth of abnormal new blood vessels in the choriocapillaris of the eye and stops blood and protein leakage below the macula thereby improving vision in patients with chorioretinal vascular diseases. Banking on the promising results from its clinical trials, Novartis plans to file for regulatory approval of this drug in 2018.
Similar drugs in pipeline
Among the upcoming competitors, Allergan’s abicipar pegol (being developed with Switzerland’s Molecular Partners) is expected to produce its first set of phase 3 results in wet AMD in 2018. Another player, Samsung Bioepis Co., Ltd plans to start phase 3 clinical trials for its proposed biosimilar SB11 (to Lucentis) by end of 2017. Lampalizumab (being developed by Genentech for the treatment of geographic atrophy secondary to age-related macular degeneration) has reported some exciting progress and was shown to reduce the size of the GA by 20% at the end of 18 months. In a certain subgroup of patients who had a particular factor D in their system, the rate of progression was decreased by 44% in that same time. With all these promising developments in the field of AMD, seniors citizens afflicted with slow vision loss, may soon have better treatment options.