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Kodiak Sciences (KOD)
:KOD
Sham Comparator, Ksi-101
Macular Edema Secondary To Inflammation
Phase III
Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE
May 21, 2025
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Sham Comparator, Ksi-101
Macular Edema Secondary To Inflammation
Phase III
Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
May 17, 2025
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Aflibercept, Tarcocimab Tedromer, Tabirafusp Tedromer
Wet Age-Related Macular Degeneration
Phase III
Active Not Recruiting
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Aug 12, 2024
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Sham Injection, Tarcocimab
Diabetic Retinopathy
Phase III
Active Not Recruiting
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)
Feb 14, 2024
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Kodiak Sciences (KOD) have in its pipeline
KOD is currently developing the following drugs: Sham Comparator, Ksi-101, Sham Comparator, Ksi-101, Aflibercept, Tarcocimab Tedromer, Tabirafusp Tedromer. These drug candidates are in various stages of clinical development as the company works toward FDA approval.