Outlook Therapeutics (OTLK) Study Update summary

Study design and objectives

• NORSE-8 is a phase three non-inferiority study requested by the FDA to provide a second well-controlled trial for ONS-5010 in wet AMD patients.

• The trial was designed as a 12-week study with an eight-week primary efficacy endpoint.

Efficacy and visual acuity results

• Visual acuity improvements were observed in both study arms at each visit, with gains increasing over time.

• ONS-5010 achieved a mean change in BCVA of 5.5 letters versus 6.5 letters for ranibizumab at week 12, demonstrating statistical non-inferiority (p=0.0043).

• Both arms were non-inferior at weeks 4 and 12, narrowly missing the margin at week 8.

• Patients gained vision instead of losing it, consistent with previous NORSE-2 results.

Anatomical outcomes

• Both study arms showed rapid and sustained decreases in central retinal thickness, indicating reduced fluid in the eye.

• No significant difference was observed between the two arms in anatomical outcomes.

• These findings add to the totality of evidence for ONS-5010's efficacy.