Bayer has applied to the authorities of the European Union and Japan for a new therapeutic indication of Aflibercept (solution for injection) in preterm infants with Retinopathy of the Premature (Rop). “Our clinical development program for premature babies with ROP addresses an important medical need in the vulnerable pediatric patient population that faces severe vision problems. Applications for authorization to the UEe and Japan are another step. forward in our commitment to addressing the needs of patients with eye disease, “said Christian Rommel of the Executive Committee of Bayer AG’s Pharmaceuticals Division and head of Research and Development.
Retinopathy of the premature baby is one of the most serious eye diseases, which can lead to a significant deterioration of vision and blindness resulting from detachment of the retina. It is estimated that around 50,000 prematurely born babies, who survive the neonatal period, develop ROP that can put their sight at risk every year. Bayer’s application to regulatory authorities is based on the 6-month results of the Phase III ‘Firefleye’ study of Aflibercept 0.4 mg versus laser, presented at the 21st congress of the European Society of Retinal Specialists (Euretina), as well as and on the preliminary data of the Phase III b ‘Firefleye next’ study, still ongoing, with long-term follow-up.
“The results of the ‘Firefleye’ study show that treatment success was numerically higher with Aflibercept than with laser treatment – said Andreas Stahl, head of the Department of Ophthalmology at the University medical center of Greifswald – and was achieved in most cases with a single injection in each eye suitable for treatment, with a less frequent need for additional interventions and a lower requirement for general anesthesia, compared to laser “.
In the ‘Firefleye’ study – the note continues – Aflibercept showed a positive risk-benefit profile in 113 patients affected by Rop treated in 27 countries around the world. This is the first prospective randomized clinical trial, which compares Aflibercept with lasers in preterm infants with ROP in need of treatment. Although the Phase III ‘Firefleye’ study did not reach statistical significance for the primary endpoint in demonstrating the non-inferiority of Aflibercept 0.4 mg to laser (90% CI for treatment difference: -8.0 % to + 16.2%), the therapeutic success achieved with Aflibercept 0.4 mg (85.5%) is considered clinically relevant.
Retinopathy of the premature baby is a vascular disease of the retina of preterm babies, characterized by incomplete growth of the vessels, which favors an excessive intraocular production of the vascular endothelial growth factor (Vegf) and an abnormal development of the vessels. The most important risk factors are being born preterm and low birth weight. The mild form usually resolves spontaneously, while the severe form requires prompt treatment. Laser treatment – the standard of care for Rop – destroys retinal tissue and can be associated with significant complications such as high myopia and peripheral visual field deficit. Aflibercept, solution for intravitreal injection, aims to reduce the elevated intraocular levels of Vegf.
Aflibercept, solution for intravitreal injections, has been approved in approximately 100 countries for 5 indications in adults, including the treatment of neovascular age-related macular degeneration and the treatment of visual impairment due to: macular edema following retinal vein occlusion (Rvo; branch or central), diabetic macular edema (Dme) and myopic choroidal neovascularization (myopic Cnv). It is a fusion protein produced through genetic engineering to bind and block the effects of a substance called vascular endothelial growth factor A (Vegf-A). It can also bind to other proteins, such as placental growth factor (Pigf). Both Vegf-A and Pigf stimulate abnormal blood vessel growth in patients with certain retinal diseases. By blocking them, Aflibercept reduces the formation of blood vessels and controls fluid leaks and edema, thereby slowing the progression of the disease.
#Retinopathy #premature #baby #Bayer #asks #Japan #injectable #therapy