Stealth BioTherapeutics Inc. announced the successful and favorable outcomes of an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) for elamipretide, its lead drug candidate for the treatment of dry age-related macular degeneration (AMD). The end-of-phase 2 Meeting scope included all aspects of the elamipretide development plan and clinical data, including the correlation analyses between anatomical (total ellipsoid zone attenuation) and functional (low light-best corrected visual acuity (LL BCVA)) outcomes. The analyses demonstrated that patients with a greater degree of ellipsoid zone (EZ) integrity showed a better functional response in elamipretide-treated patients.1 These findings support that EZ attenuation is likely to predict disease progression and suggest clinical and functional benefit of elamipretide in dry AMD.

Following the meeting, the FDA's minutes confirmed EZ attenuation as an approvable endpoint in dry AMD. Results from the ReCLAIM-2 trial in dry AMD were recently presented by Dr. Peter K. Kaiser, from the Cole Eye Institute at the Cleveland Clinic, at the Clinical Trials at the Summit Meeting on June 10, 2023, in Park City, Utah.