ROP affected 27,000 premature neonates in the US in 2019. Credit: ANNA GRANT/Shutterstock.

The US Food and Drug Administration (FDA) has granted fast track designation to FELIQS’ lead product FLQ-101, for preventing retinopathy of prematurity (ROP).

FLQ-101, which can be administered orally or intravenously once daily, aims to enhance the physiological response of vascularisation in the retina and offers protection against inflammation and abnormal neovascularisation.

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The company is preparing to launch a Phase Ib/II study, named tROPhy-1, in the US and Japan in the first quarter of 2025.

The FDA also granted orphan drug designation to FLQ-101 earlier in 2024.

FELIQS is preparing to submit an investigational new drug application for its second asset, FLQ-104, to treat intermediate dry age-related macular degeneration (dry-AMD) in the second half of 2025.

FELIQS co-founder and CEO Ken-ichiro Kuninobu stated: “This designation will facilitate the review process and give us better access to the FDA which should shorten the clinical development programme timeline and improve the chances of designing and conducting a successful programme.

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“We are excited that the FDA recognised the unmet medical need in the target population and that FLQ-101 could potentially close this gap.

“At FELIQS, we are committed to helping the most vulnerable members of society. This is exemplified by our focus on extremely premature neonates with the FLQ-101 programme, and elderly patients with intermediate dry-AMD with the FLQ-104 programme.”

In 2019, ROP affected 27,000 premature neonates in the US and is a leading cause of childhood blindness.

Laser photocoagulation and anti-VEGF [vascular endothelial growth factor] therapy – the two current FDA-approved treatments – are both implemented post-development of ROP and carry risks such as retinal detachment and increased risk of intraocular infection.

FLQ-101 is still an investigational medicine and has not yet been approved by regulatory authorities.