Trial Profile
Open-label, Randomized, Two-Arm, Controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal (IVT) Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (ROP)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Jun 2024
Price :
$35
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At a glance
- Drugs Aflibercept (Primary)
- Indications Retinopathy of prematurity
- Focus Registrational; Therapeutic Use
- Acronyms FIREFLeYe
- Sponsors Bayer
- 01 Jun 2024 Results assessing systemic exposure to aflibercept after intravitreal injection in premature neonates with retinopathy of prematurity, published in the Eye
- 08 Feb 2023 According to Regeneron Pharmaceuticals media release, the company has received an approval for aflibercept injection from the U.S. FDA to treat preterm infants with retinopathy of prematurity. The FDA approval is suppoted by the data from this study.
- 14 Nov 2022 According to a Bayer media release, based on the FIREFLEYE and FIREFLEYE NEXT studies, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a label extension for Eylea for intravitreal injection 40 mg/mL in a prefilled syringe for the treatment of preterm infants with retinopathy of prematurity. The final decision from the European Commission on the label extension is expected in the coming months.