Clinical Trials

Date: 2018-10-29

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the 2018 American Academy of Ophthalmology's (AAO) Annual Meeting

Company: Roche (Switzerland

Product: faricimab (RG7716 - RO6867461)

Action mechanism:

  • bispecific antibody. Faricimab is the first bispecific antibody designed specifically for intravitreal use to simultaneously bind to and neutralise both angiopoietin-2 (Ang-2) and VEGF-A with high potency and specificity. In nAMD, Ang-2 works synergistically with VEGF to drive pathologic blood vessel permeability and destabilisation, abnormal blood vessel growth and fluid leakage, which contribute to vision loss. Ang-2 also plays an important role in multiple aspects of inflammation in nAMD. 

Disease: neovascular wet age-related macular degeneration (AMD)

Therapeutic area: Ophtalmological diseases

Country: USA

Trial details:

  • STAIRWAY is a 52 week study that assessed two extended dosing regimens of faricimab 6.0mg given every 16 weeks or every 12 weeks, compared to ranibizumab 0.5 mg every four weeks. At week 24 (three months after the last of four loading doses), patients randomised to faricimab every 16 weeks switched to 12-week dosing if they were shown to have active disease, per pre-defined criteria. (NCT03038880)

Latest news:

  • • On October 29, 2018, Roche announced positive results from the phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of neovascular ("wet") age-related macular degeneration (nAMD), a leading cause of blindness globally in people aged 60 and over.[At 52 weeks, faricimab patients dosed either every 16 weeks or every 12 weeks demonstrated sustained vision outcomes comparable to ranibizumab dosed every four weeks. Results of the study were presented as a late-breaking oral presentation during the 2018 American Academy of Ophthalmology's (AAO) Annual Meeting in Chicago, Illinois, United States.
  • At week 24, 65% (n=36/55) of people treated with faricimab had no active disease, highlighting the potential of 16 week dosing in nearly two-thirds of patients. Initial vision gains, as measured by Best Corrected Visual Acuity (BCVA), were fully maintained through to week 52 with both 16 and 12 week dosing regimens. People treated with faricimab dosed every 16 weeks experienced a mean improvement of 11.4 letters from baseline, compared to 10.1 letters in patients treated with faricimab dosed every 12 weeks, and 9.6 letters in patients treated with 0.5 mg ranibizumab dosed every four weeks. The three treatment regimens were similar in both the proportion of patients gaining more than 15 letters and avoiding a loss of more than 15 letters. Comparable reductions in central retina thickness were also observed in people treated with both dosing intervals of faricimab and those treated with ranibizumab. Faricimab was well tolerated with no new safety signals observed.
  •  Based on STAIRWAY data, a global phase III programme for faricimab in nAMD is anticipated to commence in 2019.

Is general: Yes