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ARTICLE | Clinical News

Roche reports Phase II data for bispecific DME candidate

February 23, 2018 8:35 PM UTC

Roche (SIX:ROG; OTCQX:RHHBY) reported data from the Phase II BOULEVARD trial to treat diabetic macular edema (DME) showing that once-monthly 6 mg intravitreal RG7716 for 20 weeks met the primary endpoint of improving mean best corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at week 24 in treatment-naïve patients vs. Lucentis ranibizumab (13.9 vs. 10.3 letters, p=0.03). The pre-specified threshold for significance in the trial was a p-value of <0.2. The once-monthly 1.5 mg dose of RG7716 improved the endpoint by 11.7 letters.

On secondary endpoints, a greater proportion of patients in both RG7716 arms gained more than two and more than three lines of visual acuity vs. Lucentis. RG7716 was well tolerated...

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