Roche posts positive PhII results for bispecific antibody eye drug, joining Novartis in rivalry with Eylea

As Novartis battles Regeneron for a piece of its blockbuster Eylea franchise, Roche/Genentech $RHHBY is coming up quietly with a next-gen bispecific antibody which posted encouraging Phase II results late Sunday.

RG7716 is a dual anti-VEGF/anti-angiopoietin-2 antibody that targets retinal eye diseases. The BOULEVARD study compared two doses of it to Roche’s own VEGF-targeting ranibizumab (Lucentis) and found a significant improvement in adjusted best corrected visual acuity (BCVA), thereby meeting its primary endpoint. The adjusted mean improvement are 13.9 chart letters from baseline for patients given 6 mg RG7716; 11.7 letters for those given 1.5 mg RG7716; and 10.3 among those dosed with 0.3 mg ranibizumab, respectively. The p-value came in at 0.03.

While the trial was focused on diabetic macular edema (no small indication on its own), it has larger implications for eye diseases, a market currently dominated by Eylea. DME, one of the complications of diabetic retinopathy, affects roughly 750,000 people in the US.

Leerink’s Geoffrey Porges, though, came out swinging in defense of Regeneron this morning, tackling its two big rivals at Novartis and now Roche.

As we have alluded to in the past, Novartis’ (NVS, MP) brolucizumab (RTH258) pivotal trial is confusing, and the data incomplete, and we have serious doubts about the drug’s approvability. Secondly, the addition of Ang2 inhibition to VEGF inhibition, while theoretically intriguing, has so far been of modest benefit despite Roche’s posturing.

Others aren’t so sure.

In addition to cheering on brolucizumab, or RTH258 as it’s usually called, Novartis has also recently backed Swiss biotech Oculis, which is making an eyedrop alternative for injectable eye drugs.

Sandra Horning

“For the first time in diabetic macular edema, a clinically meaningful and statistically significant improvement in visual acuity compared to anti-VEGF alone has been demonstrated by simultaneously neutralizing both Angiopoietin-2 and VEGF-A with a bispecific antibody,” said Roche CMO Sandra Horning in a statement. “These Phase II results show the potential of RG7716 for people living with diabetic macular edema, a leading cause of vision loss in working-age adults.”

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