FDA Fast Tracks FELIQS’s FLQ-101 for ROP Prevention

The US Food and Drug Administration (FDA) has recently granted fast track designation to FELIQS’ leading product, FLQ-101, intended to prevent retinopathy of prematurity (ROP). This product, which can be administered either orally or intravenously once daily, is designed to enhance the body's natural vascularization response in the retina. Additionally, it offers protection against inflammation and abnormal new blood vessel growth.

FELIQS is gearing up to initiate a Phase Ib/II clinical trial named tROPhy-1 in the United States and Japan in the first quarter of 2025. The FDA had previously granted orphan drug designation to FLQ-101 earlier in 2024. The company is also planning to submit an investigational new drug application for another asset, FLQ-104, aimed at treating intermediate dry age-related macular degeneration (AMD) in the latter half of 2025.

Ken-ichiro Kuninobu, co-founder and CEO of FELIQS, expressed optimism about the FDA’s fast track designation, noting that it would facilitate the review process and enhance access to the FDA. This, in turn, could shorten the timeline for the clinical development program and increase the likelihood of a successful outcome. He emphasized the importance of addressing the unmet medical needs of the target population, highlighting FLQ-101’s potential to bridge this gap.

Kuninobu underscored FELIQS’ commitment to aiding the most vulnerable, with a focus on extremely premature neonates through the FLQ-101 program and elderly patients through the FLQ-104 program. In 2019, ROP impacted 27,000 premature neonates in the United States, making it a leading cause of childhood blindness. The current FDA-approved treatments, laser photocoagulation and anti-VEGF (vascular endothelial growth factor) therapy, are typically administered after the development of ROP and come with risks such as retinal detachment and increased chances of intraocular infection.

It is important to note that FLQ-101 is still an investigational medicine and has not yet received approval from regulatory authorities.