Physician Views: How do ophthalmologists rate Roche’s new Phase II data for RG7716?
Roche presented new Phase II data for its bispecific antibody RG7716 in treatment naïve diabetic macular edema patients this weekend. Analysts have had their say on the commercial outlook ahead for RG7716 (see ViewPoints: Roche's RG7716 is better than Lucentis – but what about Eylea?), but what about potential prescribers? - We are snap-polling US and EU5-based ophthalmologists to find out…
Roche has presented Phase II data (from the 229-patient BOULEVARD study) for RG7716 in diabetic macular edema; it is the first bispecific, monoclonal antibody specifically designed for the eye that simultaneously binds to and inactivates vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2).
The study met its primary endpoint, demonstrating a significant improvement in adjusted Best Corrected Visual Acuity (BCVA) at week 24 for RG7716 versus ranibizumab (Lucentis) in treatment-naïve DME patients when given as monthly intravitreal injections: 6mg RG7716 resulted in an adjusted mean improvement of 13.9 chart letters from baseline, compared to 11.7 letters in patients treated with 1.5 mg RG7716, and 10.3 letters in patients treated with 0.3mg ranibizumab.
How compelling are these data for RG7716?
How would you assess the performance of ranibizumab (Lucentis) in this study versus real-world experience in treatment naïve DME patients?
Inferior in BOULEVARD study
Superior in BOULEVARD study
At this stage, how would you evaluate these data for RG7716 in relation to aflibercept (Eylea) for the treatment of DME?
If RG7716 demonstrated similar efficacy in Phase III studies (and subsequently approved for the treatment of DME) how would you describe its commercial opportunity versus available treatments.
To what extent do you anticipate biosimilar versions of ranibizumab (Lucentis) will limit the adoption of novel therapies which demonstrate incremental benefits in efficacy (i.e. on a par with that seen for RG7716)?
Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.
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