Which DME patients are likely to achieve extended Tx intervals with faricimab?

Treatment naivety, lower baseline intraretinal fluid (IRF) and subretinal fluid (SRF) volume, lower baseline central subfield thickness (CST), greater IRF and SRF volume reduction, and greater CST reduction at week 16 in patients with diabetic macular oedema (DME) are predictive of longer treatment intervals with faricimab 6.0 mg at years 1 and 2, according to the results of the phase III YOSEMITE/RHINE trials.

YOSEMITE and RHINE were two identically designed, global, double-masked, randomized, controlled phase III trials, which evaluated faricimab 6.0 mg across three treatment groups. A total of 1,891 adults with centre-involving DME secondary to type 1 or 2 diabetes mellitus were randomized 1:1:1 to receive faricimab 6.0 mg per a personalized treat-and-extend (T&E) interval after four initial loading doses, faricimab 6.0 mg Q8W after six initial Q4W doses, or aflibercept 2.0 mg Q8W after five initial Q4W doses through week 100. In the faricimab T&E arm, treatment intervals were adjusted (Q4W–Q16W) based on prespecified CST and best corrected visual acuity (BCVA) criteria. [A Tan, Session 0392, APAO 2026]

“Faricimab demonstrated comparable BCVA gain and greater anatomical outcomes vs aflibercept [2.0 mg], with some patients achieving Q16W dosing interval,” reported Dr Anna Tan of Singapore National Eye Center, Singapore, at the 41^st Asia-Pacific Academy of Ophthalmology Congress held in Hong Kong. “In the T&E group, 78.1 percent of patients achieved a ≥Q12W dosing interval. This is an important point, as YOSEMITE/RHINE represents the first large study with T&E data in DME.”

YOSEMITE/RHINE also evaluated 21 baseline characteristics and nine treatment responses (at week 16 and year 1) as predictors of treatment interval at year 1 and year 2, by post hoc univariate and multivariable analyses. “As CST and the volume of SRF and IRF are highly correlated, these variables were analyzed separately as predictors of treatment interval to avoid multicollinearity in the model,” explained Tan.

Univariate analysis was used to shortlist variables for subsequent multivariable analysis. The variables that could predict treatment interval at year 1, which remained after stepwise backward selection, were treatment naivety, BCVA, CST or IRF + SRF, macular leakage area, and hyperreflective foci (HRF) volume. Macular leakage was the only week 16 variable, while CST or IRF + SRF, hard exudates volume, and HRF volume were the remaining change from baseline at week 16 variables. The baseline variables were the same for year 2 predictions of treatment interval following univariate analysis, but macular leakage, hard exudates volume, and HRF volume were no longer predictive.

Following the multivariable analysis, treatment naivety, lower baseline IRF and SRF volume, and greater IRF and SRF volume reduction at week 16 were found to statistically significantly (p<0.05) increase the odds of achieving a Q16W interval at years 1 and 2 in the IRF + SRF model. Similarly, treatment naivety, lower baseline CST, and greater CST reduction at week 16 significantly (p<0.05) increased the odds of achieving a Q16W interval at years 1 and 2 in the CST model.

“These findings suggest that earlier disease control with faricimab may provide long-term extended durability for patients with DME,” concluded Tan.