Bayer receives MHRA authorisation for third retinal indication of Eylea® (aflibercept 8 mg) for treatment of retinal vein occlusion
- The MHRA has granted marketing authorisation for Eylea® (aflibercept 8 mg) for the treatment of patients with macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion1
Reading, UK, 25th February 2026 – The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the use of Eylea® (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of patients with visual impairment due to macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion.1 RVO is the third indication for aflibercept 8 mg. “Retinal vein occlusion often presents with sudden vision loss and affects older people who are still of working age. Early diagnosis and treatment are essential to help prevent irreversible vision loss; however, the treatment burden of frequent injections can be challenging for patients. In the Phase III clinical trial QUASAR, aflibercept 8 mg demonstrated in the key secondary endpoint that it can meaningfully reduce the number of injections while maintaining visual acuity and providing a well-tolerated safety profile,” said Richard Gale, Professor of Ophthalmology Hull York Medical School (HYMS), University of York, and Consultant Medical Ophthalmologist, and one of the trial investigators. In the early treatment phase of RVO, treatment is intensive, with intravitreal injections usually administered in monthly intervals (every 4 weeks). In the Phase III QUASAR trial, a multicentre, randomised, double-blind study in treatment-naïve patients with macular oedema secondary to RVO, aflibercept 8 mg achieved non-inferior functional and anatomic outcomes compared to aflibercept 2 mg. At week 64, approximately three times fewer patients had a last completed dosing interval of monthly injections (every 4 weeks) with aflibercept 8 mg versus 2 mg, despite patients in all treatment arms having the option to extend dosing intervals. Patients treated with aflibercept 8 mg (after 3 initial monthly injections) not only maintained their visual acuity gains but required an average of 3 fewer injections than those receiving aflibercept 2 mg (8.4 vs. 11.7) by week 64. Importantly, fluid reduction – an indicator of disease control – was similar with extended dosing intervals of aflibercept 8 mg compared with dosing intervals of aflibercept 2 mg. The study results also showed that aflibercept 8 mg was well tolerated, and its safety profile was consistent with results from previous aflibercept 8 mg clinical trials.1,2,3 The QUASAR clinical study met its primary endpoint at week 36, demonstrating that patients receiving aflibercept 8 mg every 2 months (after 3 or 5 initial monthly injections) achieved non-inferior visual acuity gains and robust visual outcomes compared to those receiving aflibercept 2 mg monthly. At week 64, more than 60% of patients receiving aflibercept 8 mg after 3 initial monthly injections were able to achieve a last assigned treatment interval of four months and longer, with 40% having a last assigned interval of five months.1,2 The licenced posology for the treatment of nAMD and DMO with Eylea 8 mg (aflibercept 8 mg) has been updated, now allowing for a minimum treatment interval of 4 weeks (monthly dosing).1 “The MHRA’s authorisation of aflibercept 8 mg in retinal vein occlusion provides clinicians with a new treatment option with the potential for more durable dosing – helping to ease the burden of frequent injections while preserving the vision outcomes that matter most to patients. As pressures on eye care services continue to grow, therapies with extended dosing intervals have the potential to create efficiencies for NHS clinics while maintaining high standards of care. This approval broadens the retinal indications for aflibercept 8 mg in the UK and reinforces our commitment to working closely with the NHS to strengthen retinal pathways and improve outcomes for those living with sight‑threatening conditions,” said Tomer Feffer, CEO UK&Ireland, Head of Region Northeast-Central Europe at Bayer. About RVO Retinal vein occlusion (RVO) is a chronic condition that can lead to sudden, rapid loss of vision, currently affecting 28 million adults globally.4 It is estimated that approximately 17,300 people with RVO suffer from visual impairment due to macular oedema each year in England and Wales.5 There are two main types of RVO – central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). CRVO occurs when there is a blockage in the main vein of the retina at the optic nerve. BRVO occurs when the smaller, branch retinal veins are obstructed, and is up to four to six times more common than CRVO. Hemiretinal vein occlusion (HRVO) refers to the occlusion of a vein that supplies one half of the retina. RVO can lead to a reduced oxygen supply to the retina, increasing the production of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF). The blocked vein can cause fluid and blood to leak into the retina resulting in swelling and bleeding within the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This swelling is called macular oedema, and VEGF plays a major role in driving this pathology.5-8
About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.co.uk.
Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References:
PP-EYL_8mg-GB-0912 / February 2026 |
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