Enrolment has been completed in a two-year Phase 3 trial evaluating an oral medication for geographic atrophy (GA).

The Phoenix study is being held at sites in eight countries, including Australia.

The trial is evaluating the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in patients diagnosed with GA in dry age-related macular degeneration (AMD).1

Belite Bio, a clinical-stage drug development company focussed on advancing novel therapeutics targeting degenerative retinal diseases, said completion of enrolment in the Pheonix trial marked an “important milestone” in the advancement of the drug’s development.

“This achievement brings us one step closer to evaluating the potential of Tinlarebant to slow atrophic lesion growth in this serious and progressive disease for which there are no approved oral treatments,” said Belite Bio Chairman and CEO Dr Tom Lin.

“There remains a significant unmet need for this patient population. We remain committed to advancing Tinlarebant through late-stage development and look forward to sharing interim results at the midpoint of the Phoenix trial.”

Tinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in patients with Stargardt disease type 1 (STGD1) and geographic atrophy.

Reference

1. Belite Bio, Belite Bio announces completion of enrollment in the pivotal global Phase 3 Phoenix trial evaluating oral Tinlarebant in geographic atrophy (media release, 2 July 2025) available at: investors. belitebio.com/news-releases/news-releasedetails/belite-bio-announces-completionenrollment-pivotal-global-phase [accessed July 2025].