Japanese pharmaceutical company FELIQS announced recently that the US Food and Drug Administration (FDA) has granted its lead asset, FLQ-101, fast track designation for the prevention of retinopathy of prematurity (ROP). The company intends to conduct a phase1b/2 study of FLQ-101 (tROPhy-1 study) in the United States and Japan in the first quarter of 2025, the company said in a press release. 

FLQ-101 is a once-daily oral/intravenous solution that enhances the physiologic response of vascularization in retina and protects from inflammation and abnormal neovascularization, the company said. Earlier this year, the FDA granted FLQ-101 orphan drug designation. 

The FDA grants investigational medicines fast track designation to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need. In the United States, ROP remains one of the leading causes of childhood blindness, afflicting about 27,000 premature neonates annually.