Full results from Roche and Genentech’s phase 2 BOULEVARD study have been published in the journal, Ophthalmology. The study shows the investigational molecule, faricimab, was superior to ranibizumab in achieving visual acuity gains for people with diabetic macular edema (DME). Further, faricimab treatment consistently showed an advantage over ranibizumab in other visual and anatomic outcomes, as well as increased durability, which could potentially mean less frequent treatments for patients, according to a Roche and Genentech statement.
Faricimab is a novel, bispecific antibody that simultaneously binds to and inhibits both vascular endothelial growth factor A (VEGF-A) and Angiopoietin-2 (Ang-2), and is the first bispecific antibody designed specifically for the treatment of retinal eye diseases.
The study met its primary endpoint by demonstrating a statistically significant improvement in best-corrected visual acuity (BCVA) in treatment-naïve patients at 24 weeks for faricimab 6.0 mg versus ranibizumab alone, with an adjusted mean difference of +3.6 letters.
Patients in BOULEVARD were treated monthly for 20 weeks with faricimab, 1.5 mg or 6.0 mg, or ranibizumab 0.3 mg. At 24 weeks, the mean visual acuity gains (letters on an eye chart) for each treatment group were:
- +13.9 letters with 6 mg RG7716
- +11.7 letters with 1.5 mg RG7716
- +10.3 letters with ranibizumab 0.3 mg
Treatment with faricimab 6.0 mg also resulted in significantly more patients gaining more than 2 lines (72.1 percent), and more than 3 lines (42.5 percent), of vision of an eye chart compared to ranibizumab (59.2 percent and 35.3 percent, respectively). In addition, nearly 40 percent of patients in the faricimab 6.0 mg arm saw a two-step or better improvement in the severity of their diabetic retinopathy. Faricimab showed new or unexpected adverse events and no reports of intraocular events in BOULEVARD.
Importantly, BOULEVARD showed that many patients treated with faricimab could potentially go up to 16 weeks before needing to be retreated. The current standard of care for DME requires as often as monthly anti-VEGF injections, which places a high treatment burden on patients and caregivers. This can potentially lead to suboptimal treatment outcomes. By allowing for a less frequent treatment schedule, faricimab could potentially reduce this burden for patients.
Faricimab is currently being studied in two phase 3 clinical trials in DME – YOSEMITE (NCT03622580) and RHINE (NCT03622593) – which began in September 2018. Two phase 3 clinical trials studying faricimab in wet age-related macular degeneration (AMD) – TENAYA (NCT03823287) and LUCERNE (NCT03823300) – were initiated in February 2019.