FELIQS announced the FDA has granted its lead asset, FLQ-101, Fast Track designation for the prevention of retinopathy of prematurity (ROP). FELIQS plans to conduct a Phase1b/2 study of FLQ-101 (tROPhy-1 study) both in the United States and Japan in 1Q2025, 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.

In 2024, the FDA granted FLQ-101 orphan drug designation. Additionally, the company says it is on track to submit an IND for its second asset, FLQ-104, for intermediate dry AMD in 2H2025.

"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," said Ken-ichiro (Nobu) Kuninobu, PhD, RPh, co-founder and CEO at FELIQS, in the press release. “We are excited that the FDA recognized the unmet medical need in the target population and that FLQ-101 could potentially close this gap. At FELIQS, we are committed to help the most vulnerable members of society. This is exemplified by our focus on extremely premature neonates with the FLQ-101 program and the elderly patients with intermediate dry AMD with the FLQ-104 program."