Can ROP Be Prevented?

The phase 1b tROPhy-1 study is evaluating FLQ-101, an investigational therapy designed to intervene before severe disease develops.

By: Jim Gallagher, senior managing editor

Retinal Physician June 23, 2026

Clinical Report: Can ROP Be Prevented?

Overview

The ongoing phase 1b tROPhy-1 study is evaluating FLQ-101, an investigational therapy aimed at preventing retinopathy of prematurity (ROP) before it develops.

Background

Retinopathy of prematurity (ROP) is a leading cause of pediatric blindness in the United States, affecting approximately 30% to 40% of the 20,000 premature infants born annually. Current management strategies rely on identifying and treating infants with established disease.

Data Highlights

The phase 1b tROPhy-1 study is enrolling infants in a dose-escalation design consisting of low-, medium-, and high-dose cohorts. The study aims to evaluate safety and signals of reduced ROP development.

Key Findings

FLQ-101 is designed to prevent the onset of proliferative ROP by intervening during the hyperoxic vaso-obliterative phase.
The investigational therapy is a small-molecule lipid peroxidation inhibitor that interrupts oxidative stress pathways in the retina.
Preclinical studies have shown preservation of retinal structure and function in models of retinopathy.
FLQ-101 has received orphan drug and fast track designations from the FDA.
The study is expected to complete enrollment later this year.

Clinical Implications

The findings from the tROPhy-1 study could lead to a paradigm shift in the management of ROP, emphasizing prevention rather than treatment. This may address the current challenges in screening and treating at-risk infants.

Conclusion

The tROPhy-1 study represents a significant advancement in the potential prevention of ROP, with results expected to inform future clinical practices and treatment strategies.

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