Business
Kodiak Sciences Announces Third Quarter 2020 Financial Results and Recent Business Highlights
PALO ALTO, Calif., Nov. 9, 2020 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and
About this update from Kodiak Sciences Inc
[{"type":"text","content":"PALO ALTO, Calif., Nov. 9, 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 reported business highlights and financial results for the third quarter ended September 30, 2020.\n\"We continue our strong execution in this second half of 2020,\" said Victor Perlroth, MD, Chief Executive Officer of Kodiak. \"Our DAZZLE study of KSI-301 in wet age-related macular degeneration has only a handful of patients left to enroll, and we are now enrolling GLEAM and GLIMMER in Diabetic Macular Edema and BEACON in Retinal Vein Occlusion. With over 300 retina specialists, clinical coordinators and staff having participated in our most recent Virtual Investigator Meeting, we are humbled and inspired by the receptivity and enthusiasm of the retina community for KSI-301 and its emerging clinical profile. These accomplishments, powered by our growing Kodiak team, bring us one step closer to a series of top-line data readouts beginning in early 2022. This 2022 Vision will, if successful, enable a single multi-indication BLA filing in 2022.\"\nRecent Business Highlights\nUpgraded Pivotal Study Program: We finalized the design of our KSI-301 pivotal study programs in RVO and DME and have launched all three studies. We are currently conducting two Phase 3 studies in DME (GLEAM and GLIMMER) to provide the mutually-confirmatory studies required by FDA for initial demonstration of safety and efficacy, one study in wet AMD (our ongoing DAZZLE study), and one study in RVO (BEACON). Each study protocol design has been optimized based on Phase 1b data and experience and will include the same treatment-naïve patient populations as in the Phase 1b, as well as tighter dosing interval ranging, tighter disease control, and decreased subjectivity for retreatments, and each has high statistical power for non-inferiority (>90%). We also intend to initiate in early 2021 a Phase 3 study of KSI-301 in non-proliferative diabetic retinopathy (GLOW). DAZZLE Study Progress: We saw robust patient enrollment through the third quarter of 2020 and have completed U.S. patient recruitment into our DAZZLE pivotal study in wet AMD – a potential reflection of the enthusiasm for KSI-301 on the part of clinical investig...