Kodiak Sciences ((KOD)) announced an update on their ongoing clinical study.
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Study Overview: Kodiak Sciences is conducting a Phase 3 study titled A Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) – PEAK. The study aims to assess the efficacy and safety of KSI-101 in treating macular edema caused by inflammation, a significant condition affecting vision.
Intervention/Treatment: The study tests the drug KSI-101, administered via intravitreal injection. Two experimental groups receive 5 mg and 10 mg doses, respectively, while a control group receives a sham injection. The treatment is intended to reduce inflammation and improve vision in affected individuals.
Study Design: This interventional study is randomized and uses a parallel assignment model. It employs quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are unaware of group assignments. The primary purpose is treatment-focused.
Study Timeline: The study began on May 17, 2025, with the last update submitted on September 3, 2025. These dates are crucial as they indicate the study’s progress and ongoing recruitment status.
Market Implications: The study’s progress could influence Kodiak Sciences’ stock performance, as positive results may enhance investor confidence and market position. The study’s outcome could also impact competitors in the ophthalmology sector, highlighting the importance of innovation in treating inflammatory eye conditions.
The study is currently ongoing, with further details available on the ClinicalTrials portal.