The complete first-time results of the STAIRWAY study were presented at the recent American Academy of Ophthalmology (AAO) Annual Meeting in Chicago. The data was presented on Retina Subspecialty Day by Dr. Arshad Khanani, the managing partner and director of clinical research at Sierra Eye Associates in Reno, NV.
STAIRWAY compared extended dosing at every 16 weeks (Q16W) and every 12 weeks (Q12W) of faricimab versus every 4 weeks (Q4W) dosing of ranibizumab in patients with neovascular age-related macular degeneration (nAMD). Faricimab is the first bispecific antibody to be designed for intraocular use. It is one molecule with two targets: One arm blocks VEGF-A and the second arm blocks ANG-2. The Fc portion of the antibody has been modified to decrease systemic absorption as well as inflammatory potential.
STAIRWAY was a prospective, randomized, phase 2 study that included 76 treatment-naïve patients with nAMD. The baselines characteristics were essentially well-balanced except that the patients in the ranibizumab group had slightly lower best correct visual acuity (BCVA) and greater central subfield thickness (CST). Patients were randomized in 3 different arms. In the 2 faricimab groups, patients received 4 monthly dosings followed by either a Q16W or Q12W dosing of faricimab. The third treatment group received monthly ranibizumab.
Disease activity assessment was done at week 24 using 6 strict protocol-defined criteria, which included BCVA, OCT, clinical examination, and investigator assessment. If patients were found to have disease activity, they were moved down from Q16W dosing to Q12W dosing. The disease activity assessment showed that 65% of patients treated with faricimab had no disease activity 12 weeks after their last injection.
The 52-week data from the STAIRWAY study supported extended durability of faricimab compared to monthly ranibizumab. Patients who received Q16W and Q12W of faricimab fully maintained their BCVA gains throughout the study. Patients gained 11.42 letters in the Q16W group, 10.08 letters in the Q12W group and 9.59 letters in the ranibizumab group.
The study also looked at anatomic changes in each group. On OCT, CST reductions in the patients treated with Q16W and Q12W faricimab were comparable to Q4W ranibizumab. On fluorescein angiography, the CNV lesion size reductions with Q16W and Q12W faricimab were similar to Q4W ranibizumab.
The proportion of patients gaining 3 lines of vision and not losing 3 lines of vision were also similar between all groups. There were no new safety signals identified.
Dr. Khanani concluded his presentation by stating that "the data from the STAIRWAY study shows the potential of faricimab to reduce treatment burden in patients with nAMD as patients treated with faricimab Q16W and Q12W had BCVA and anatomic improvements that were comparable to monthly ranibizumab. This supports moving forward with a global phase 3 faricimab program in nAMD that will start early next year."