Positive FDA Type A Meeting Reaffirms APOLLO As Bito's Path To Approval

Research evidence excerpt

Positive FDA Type A Meeting Reaffirms APOLLO As Bito's Path To Approval

TD Cowen Disc Medicine

Global Research June 9, 2026

Disc Has Wisely Accounted For Factors Such As Baseline Light Tolerance And Geography In

APOLLO's Design In Order To Mitigate Variability

Management explained key design elements that were implemented in APOLLO's design

to mitigate variability and ensure robustness. These include stratification by baseline light

tolerance (centered around a ~30-minute median) and broad geographic region (north vs.

south) to address differences in ambient sunlight exposure. Enrollment was approximately

balanced between US and ex-US geographies, although differences in study exit timing –

particularly European patients skewing toward spring/summer due to later site activation –

are not expected to materially impact interpretation. Prior AURORA analyses demonstrated

consistent treatment effects across seasons, with only modest variation in absolute

magnitude. Baseline disease characteristics are similarly well characterized, with most

patients clustering in the 10–60 minute daily light tolerance range despite a broader potential

span.

Diary-Based Assessment Of Light Exposure Is A Rigorous Study Method In EPP

The diary-based assessment of light exposure remains a core component of the study and, in

management’s view, a well-validated and disease-relevant endpoint. Patients log time in light

using a dedicated device, recording exposure in hourly increments alongside any phototoxic

reactions. Rather than imposing rigid definitions of direct versus indirect light, the study relies

on patient-specific interpretation of meaningful exposure, consistent with how EPP patients

naturally navigate their environment. This approach was prospectively validated, with patients