Drugmaker’s DME candidate hits mark in two Phase III studies

Roche recently announced positive results from two global Phase III studies evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME).

The Yosemite and Rhine studies met their primary endpoint and showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks.

According to a news release, faricimab was generally well-tolerated, with no new safety signals identified. The studies each have three treatment arms, with participants randomly assigned to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalized intervals of up to 16 weeks, following a loading phase.

“These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular edema, while also reducing the treatment burden associated with frequent eye injections,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, said in a statement. “We look forward to discussions with global regulatory authorities, with the aim of bringing this potential new treatment option to people with this condition as soon as possible.”

In a secondary endpoint, across both studies, more than half of participants in the faricimab personalized dosing arms achieved an extended time between treatments of 16 weeks at year one.

According to the release, this was the first time any investigational medicine has achieved this level of durability in a phase III study of people with DME.

Yosemite (NCT03622580) and Rhine (NCT03622593) are two identical, randomly assigned multicenter, double-masked, global phase III studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people living with diabetic macular edema (940 in Yosemite and 951 in Rhine).

According to the release, the studies each have three treatment arms: faricimab 6.0 mg administered at personalized dosing intervals of up to 16 weeks; faricimab 6.0 mg administered at fixed eight-week intervals; aflibercept 2.0 mg administered at fixed eight-week intervals.

In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.

According to the release, the primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at one year.

Secondary endpoints include safety; the percentage of participants in the personalized dosing arm receiving treatment every four, eight, 12 and 16 weeks, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain of at least 15 letters in BCVA from baseline over time; the percentage of participants avoiding a loss of at least 15 letters in BCVA from baseline over time; and change in central subfield thickness from baseline over time.

In addition to the YOSEMITE and RHINE studies, the phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME.

Faricimab is also being studied in the phase III TENAYA and LUCERNE studies as a potential treatment for neovascular or “wet” age-related macular degeneration (nAMD).