FDA Grants Fast Track Designation to Oral Molecule FLQ-101 for Retinopathy of Prematurity

The U.S. FDA has granted fast track designation to FLQ-101, FELIQS’ oral and intravenous solution targeting retinopathy of prematurity (ROP). This designation will accelerate the regulatory review process for FLQ-101, a promising treatment for a condition currently lacking approved preventative therapies.

About FLQ-101: A Novel Approach to Retinopathy of Prematurity

FLQ-101 is designed as a once-daily oral and intravenous solution to treat ROP by targeting inflammation and abnormal blood vessel growth in the retina. This molecule stimulates a physiological response that supports healthy vascularization, addressing the root causes of this severe condition. Earlier this year, FLQ-101 was granted orphan drug designation, underscoring its potential to fill a significant treatment gap in neonatal eye care.

FDA Fast Track Designation: Accelerating the Development Timeline

With fast track status, FLQ-101 will benefit from a streamlined FDA review process, which is reserved for treatments addressing unmet needs in serious conditions. This designation offers FELIQS greater FDA access, potentially shortening the clinical development timeline for FLQ-101.

“With no approved preventative treatments available for retinopathy of prematurity, receiving the fast track designation for FLQ-101 is an important milestone for our company,” said Ken-ichiro (Nobu) Kuninobu, PhD, RPh, co-founder and CEO of FELIQS. “This designation will facilitate the review process and give us better access to the FDA, which should shorten the clinical development program timeline and improve the chances of designing and conducting a successful program. We are excited that the FDA recognized the unmet medical need in the target population and that FLQ-101 could potentially close this gap.”

Next Steps: Phase 1b/2 Trial and Future Developments

FELIQS is preparing to initiate a phase 1b/2 study of FLQ-101 in both the U.S. and Japan in 2025, marking a critical step toward bringing this treatment to clinical use. Additionally, FELIQS plans to submit an Investigational New Drug (IND) application next year for FLQ-104, a therapeutic aimed at treating intermediate dry age-related macular degeneration (AMD).

The FDA’s fast track designation is a significant milestone in advancing FLQ-101 toward becoming a breakthrough treatment option for retinopathy of prematurity.