Kodiak Sciences ((KOD)) announced an update on their ongoing clinical study.
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Study Overview: Kodiak Sciences is conducting a Phase 3 clinical trial 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) – PINNACLE.’ The study aims to assess the efficacy and safety of KSI-101, a potential treatment for macular edema caused by inflammation, a condition that can lead to vision impairment.
Intervention/Treatment: The study is testing an intravitreal injection of KSI-101, available in 5 mg and 10 mg doses, administered every four weeks for six months, followed by individualized dosing. A sham comparator is also used to evaluate the treatment’s effectiveness.
Study Design: This interventional study is randomized and follows a parallel assignment model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are unaware of the group assignments. The primary purpose of the study is treatment-focused.
Study Timeline: The study began on May 21, 2025, with the last update submitted on September 6, 2025. These dates mark the progress of the study, indicating that it is currently in the recruitment phase.
Market Implications: The ongoing study could significantly impact Kodiak Sciences’ stock performance, as positive results may enhance investor confidence and position the company as a leader in treating macular edema. The competitive landscape in ophthalmology treatments could see shifts depending on the outcomes, potentially affecting other companies in the sector.
The study is ongoing, with further details available on the ClinicalTrials portal.