Tags : Diabetic Retinopathy

Boehringer Ingelheim and Pharmaxis Halt the Development of BI 1467335

Shots: The companies discontinue the P-IIa study assessing BI 1467335 vs PBO in 79 patients with moderately severe to severe NPDR without CIDME for 12wks. treatment period with an additional 12wks. follow-up period afterward. The study met its 1EPs in ocular safety with the treatment being well-tolerated The discontinuation is due to a lack of […]Read More

Regeneron Reports Results of Eylea (aflibercept) in P-III PANORAMA Study

Shots: The P-III PANORAMA study involves assessing Eylea [inj. 2mg (0.05ml), q8w/q16w] vs sham in 402 patients with moderately severe to severe NPDR without DME The P-III PANORAMA study results: @2yrs. 75% reduction in vision-threatening events, patients demonstrated greater improvement in the DRSS score from baseline (80% @52wks and 50% @100 wks.) in q8w group […]Read More

Regeneron Announces FDA Review Acceptance of EYLEA’s sBLA for the

Shots: The sBLA involves results of P-III PANORAMA trial assessing EYLEA treatment from moderate severe-to-severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME) The announced PDUFA date for EYLEA by US FDA is 13 May, 2019. PANORAMA six months’ results has been announced in March 2018 with expected one year results in H2’18 EYLEA […]Read More