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Kodiak Sciences Completes Enrollment of DAZZLE Phase 2b/3 Pivotal Study of KSI-301 in Patients with Wet Age-Related Macular Degeneration
− On track for DAZZLE primary endpoint last patient last visit in late 2021 and topline results in early 2022 − Over 550 patients enrolled worldwide − Phase 3
About this update from Kodiak Sciences Inc
[{"type":"text","content":"− On track for DAZZLE primary endpoint last patient last visit in late 2021 and topline results in early 2022\n − Over 550 patients enrolled worldwide\n − Phase 3 studies for diabetic macular edema and retinal vein occlusion enrolling well and on track for topline results also in 2022\n\n\nPALO ALTO, Calif., Nov. 16, 2020 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today announced that recruitment has concluded in its DAZZLE pivotal study of KSI-301, Kodiak's anti-VEGF antibody biopolymer conjugate, in patients with neovascular (wet) age-related macular degeneration. DAZZLE was planned to enroll 550 treatment-naïve patients worldwide; the target enrollment has been exceeded and recruitment into the study is now closed. \n\"We are pleased to have exceeded our enrollment target for DAZZLE and to have recruited the study in just over one year despite the challenges presented by the COVID-19 pandemic. We are very grateful for the enthusiasm and support of the retina clinical trial community in working together with us to study KSI-301's potential,\" said Victor Perlroth, Chief Executive Officer of Kodiak Sciences. \"With DAZZLE having a one-year primary efficacy endpoint, Kodiak is on track for a top-line data readout of the study in early 2022, an important milestone as part of our 2022 Vision.\"\n\"Wet AMD remains a leading cause of vision loss in the elderly and real-world data show that vision outcomes are compromised by the unsustainable and intensive treatment burden of current medicines. In DAZZLE, we are studying a more pragmatic and achievable regimen of KSI-301 given once every three, four or five months,\" said Jason Ehrlich, MD, PhD, Kodiak's Chief Medical & Development Officer. \"We look forward to the last DAZZLE patient's one-year visit in late 2021 and to analyzing and releasing the primary results in early 2022. The Kodiak team is also executing well on the rest of the KSI-301 development program. Our pivotal studies in diabetic macular edema (DME) and retinal vein occlusion are off to a strong start. The recent presentation of KSI-301 data at the American Academy of Ophthalmology Virtual Meeting highlighted the promising combination of efficacy and durab...