Two phase III trials of RTH 258 show reduced eye damage in age-related macular degeneration.- Novartis.

Novartis announced further positive results from two Phase III studies of RTH 258 (brolucizumab) versus aflibercept in patients with neovascular age-related macular degeneration (nAMD), a leading cause of blindness. In neovascular AMD, abnormal blood vessels leak fluid into the eye, ultimately causing damage and blindness. At week 16, relative to aflibercept, 35% fewer brolucizumab 6 mg patients showed presence of intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF) in HAWK, and 33% fewer in HARRIER. Again at week 48, relative to aflibercept, 31% fewer patients on brolucizumab 6 mg had intra-retinal fluid and/or sub-retinal fluid in HAWK, and 41% fewer in HARRIER. The absence of fluid for patients in the brolucizumab arm suggests the potential for a long-lasting effect and decreased treatment need.

Additionally, brolucizumab 6 mg patients demonstrated superior reductions in central subfield thickness (CST). In nAMD, an elevated CST-as measured by optical coherence tomography (OCT)-is a key indicator of abnormal fluid accumulation in the retina. Significantly improved CST reductions were evident at week 16 (P=0.0016 in HAWK and P<0.0001 in harrier and at week 48.>

Brolucizumab met the primary efficacy endpoint of noninferiority to aflibercept in mean change in best-corrected visual acuity (BCVA) from baseline to week 48 in both trials. These results were achieved while a majority of brolucizumab patients-57% in HAWK and 52% in HARRIER-were maintained on a q12w dosing interval immediately following the loading phase through week 48. The results of the head-to-head trials, HAWK and HARRIER, were presented at the American Academy of Ophthalmology (AAO) 2017 Annual Meeting.