I think the P1 data is old data ...just being presented at this conference ...my first take From Gemini
Clinical data for KSI-101 in the treatment of Macular Edema Secondary to Inflammation (MESI) is very strong, with the Phase 1b APEX study demonstrating high efficacy and a favorable safety profile. These results were positive enough that Kodiak has already advanced the drug into two pivotal Phase 3 studies. Key Performance Indicators (Phase 1b APEX Study) The Phase 1b data showed consistent, rapid, and sustained improvements across multiple metrics: Vision Gains: Over 50-60% of patients at the top dose levels (5 mg and 10 mg) achieved a $\ge$15-letter gain (3 lines on the eye chart) by week 12. Retinal Drying: More than 90% of patients achieved complete retinal dryness by week 8, with many showing improvement as early as week 1. Safety: The drug was well tolerated with no major safety concerns reported, a significant advantage over current steroid-based treatments that often cause side effects. Broad Activity: Results were consistent across diverse MESI etiologies (uveitic, idiopathic, etc.), suggesting it could serve as a unifying first-line therapy. Future Outlook Kodiak is currently enrolling patients in the PEAK and PINNACLE Phase 3 trials. Topline data from these studies is expected between Q4 2026 and Q1 2027. Experts have noted that the "drying effect" of KSI-101 is on par with or better than existing steroid implants like Ozurdex but without the associated risks.
They jump straight from P1 to 2 P3 pivotal trials . That high confidence as pivotal P 3 trials are usually large and very expensive JMO
Ah. Here you are
The Phase 1b clinical data for KSI-101 in patients with Macular Edema Secondary to Inflammation (MESI) from the APEX study was first publicly announced on August 13, 2025.
Subsequent detailed and follow-up data sets were published as follows: Initial APEX Data (DME and MESI): Announced via Kodiak Sciences Business Highlights on August 13, 2025, showing rapid anatomical gains by Week 1.
Retina Society Presentation: New data reinforcing clinically meaningful vision gains were presented at the Retina Society 58th Annual Scientific Meeting on September 15, 2025.
Week 20 Follow-up Data: Released on November 5, 2025, highlighting that over 90% of patients achieved an absence of intraretinal and subretinal fluid.
Final Week 24 Data: Scheduled to be presented at the Angiogenesis, Exudation, and Degeneration 2026 Annual Meeting on February 7, 2026.
Thx for prompting me to do some DD Theres probably going to be some important safety data released ...plus durability
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