FDA Fast Tracks FELIQS' FLQ-101 for Preventing Retinopathy of Prematurity (ROP)

The U.S. Food and Drug Administration (FDA) has granted fast-track designation to FELIQS’ lead product, FLQ-101, which aims to prevent retinopathy of prematurity (ROP). FLQ-101 can be administered orally or intravenously once daily and is designed to enhance the physiological response of vascularization in the retina, offering protection against inflammation and abnormal neovascularization. In the first quarter of 2025, FELIQS will commence the Phase Ib/II tROPhy-1 study in the US and Japan.

Publish Date: 04-11-2024 Source: Feliqs Corporation

Retinopathy of prematurity (ROP) is an eye disease that affects some premature babies born before 31 weeks. A full-term pregnancy lasts between 38 -42 weeks. It is a condition that affects the retina, the tissue at the back of the eye. The retina detects light and sends signals to the brain, allowing you to see. Unwanted blood vessels grow on the baby’s retina due to ROP. These blood vessels can later cause serious eye and vision problems. Sometimes immediate treatment is required to avoid blindness. If not treated promptly, the child may suffer from severe permanent vision loss or even go blind. Most babies with ROP normally see for their age. Vision is only threatened when ROP progresses to the most severe stages. Fortunately, the majority of ROP resolves without causing vision loss. The most important factors in preventing ROP-related vision loss are effective screening and timely treatment (when indicated. Birth weight and gestational age are the most critical risk factors for developing severe ROP. Other factors associated with the presence of ROP include anemia, poor weight gain, blood transfusion, respiratory distress, breathing difficulties and the infant’s overall health. There is active research into the correlation between levels of growth factors in the blood and ROP. Close monitoring has reduced the impact of oxygen use as a risk factor for developing ROP. Light levels do not affect the severity of ROP.

The incidence of ROP is approximately 50% to 60% in preterm infants with a birth weight (BW) < 1500 g, while the rate of progression to severe ROP (Stages 3–5) has been reported to be approximately 15%.

However, the current Retinopathy of Prematurity (ROP) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (rhIGF-I/rhIGFBP-3, Aflibercept, Ranibizumab, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Retinopathy of Prematurity (ROP) treatment. The key companies in the advanced development stage are Shire, Regeneron Pharmaceuticals, Novartis Pharmaceuticals, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Retinopathy of Prematurity (ROP) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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