Roche initiates 3 AMD Phase III trials

Three global Phase III studies in Genentech and Roche’s ophthalmology portfolio are underway – two for faricimab in diabetic macular oedema (DME), and one for the port delivery system (PDS) in wet AMD.

Genentech, a member of the Roche group, has announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (a bispecific antibody designed for the eye) in the treatment of wet age-related macular degeneration (AMD).

STAIRWAY is a 52-week study assessing two extended dosing regimens of faricimab 6.0 mg given every 16 weeks or every 12 weeks, compared to ranibizumab 0.5 mg every four weeks.

The study demonstrated sustained vision outcomes compared to monthly ranibizumab for people with wet AMD in a Phase II study.

“Because current anti-VEGF monotherapies for wet AMD are burdensome, requiring frequent clinic visits for eye injections, some people are under-treated and experience subsequent declining vision over time,” said Roche’s chief medical officer, Dr Sandra Horning. “The STAIRWAY data show the potential of faricimab to allow fewer injections while achieving and sustaining the same visual gains seen with a current standard of care. Based on this data, we will be initiating a global Phase III programme for faricimab in wet AMD.”

Initial vision gains, as measured by best corrected visual acuity (BCVA), were fully maintained through to week 52 with 16- and 12-week dosing regimens. People treated with faricimab dosed every 16 weeks experienced a mean improvement of 11.4 chart 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 ranibizumab 0.5 mg 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.

Rates of ocular and systemic adverse events observed with faricimab were similar to the rates observed with ranibizumab and no new safety signals were observed. Researchers said the overall safety profile of faricimab appeared consistent with the safety profile reported in patients with wet AMD who received intravitreal anti-VEGF therapies.

Further Phase II data for the port delivery system with ranibizumab (PDS), dosed every six months or longer, showed vision and anatomical outcomes in wet AMD were comparable to ranibizumab dosed every four weeks.

Top line results presented earlier this year showed the majority of PDS patients – including approximately 80 percent of patients in the high-dose PDS group – went six months or longer between the implantation and the first required refill of the device. Importantly, the researchers said, patients in the high-dose PDS group achieved similar visual outcomes as ranibizumab 0.5 mg dosed every four weeks. Based on the data of the Phase II Ladder program, the pivotal Phase III Archway clinical trial and the Portal label extension study were initiated in September 2018. These studies will evaluate the efficacy and safety of the PDS 100 mg/mL concentration in patients with wet AMD at a fixed dosing interval of 24 weeks.