At the American Academy of Ophthalmology meeting in New Orleans, Novartis announced positive results from two phase 3 studies (HAWK and HARRIER) of brolucizumab versus Regeneron's aflibercept (Eylea) in patients with neovascular age-related macular degeneration (nAMD). The Novartis press release and findings of the studies can be found here.
Following the release of the data, Genentech, the maker of ranibizumab (Lucentis), issued the following statement:
"Lucentis (ranibizumab injection) has been rigorously studied in clinical trials supporting the efficacy, durability and safety in treating patients with wet age-related macular degeneration (AMD), whether dosed quarterly, monthly or as-needed (pro re nata, PRN). Lucentis is the only anti-vascular endothelial growth factor (VEGF) treatment approved by the U.S. Food and Drug Administration (FDA) with a quarterly dosing regimen included in its label, offering patients multiple dosing options depending on what’s right for them. Since 2013, the Lucentis Prescribing Information has contained a broad dosing indication that supports flexible dosing with monthly, PRN or quarterly dosing based on a patient’s response to treatment.
Robust visual acuity gains have been demonstrated across multiple trials, including ANCHOR, MARINA, PIER, SAILOR, HARBOR and CABERNET. In the pivotal PIER study, in which, after the loading dose, patients received Lucentis every three months, the majority of patients with wet AMD treated with Lucentis sustained their initial visual acuity gains with quarterly dosing. In CABERNET, following three monthly loading doses, 71 percent of the Lucentis treated patients were dosed quarterly, with average visual acuity gains of 8.2 letters and with 31 percent achieving gains of 15 or more letters at Month 12 with quarterly dosing.
The characteristics of wet AMD can vary from patient to patient, especially with regard to the type and size of choroidal neovascularization (CNV) lesions that are present. These variations can affect the response to anti-VEGF treatment, requiring a dosing schedule tailored to each patient.
Lucentis has demonstrated its efficacy, durability and safety in more than 22 clinical trials in 9,300 patients. Based on the totality of evidence in support of its efficacy and safety profile, as well as the depth and breadth of clinical experience in treating complex retinal diseases for more than 10 years, Lucentis continues to be an important treatment choice for physicians and patients."