Bayer receives MHRA authorisation for EYLEA® 8mg (aflibercept) for two sight-threatening macular conditions
- Bayer has received marketing authorisation for aflibercept 8 mg from the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for adults with neovascular (wet) age-related macular degeneration (nAMD) and vision impairment due to diabetic macular oedema (DMO)
- The authorisation is based on results of the PULSAR and PHOTON clinical trials
- Aflibercept 8 mg is the first treatment for nAMD and DMO authorised for the extension of treatment intervals up to five months between injections – after 3 monthly loading doses and dependent upon visual and anatomical outcomes – giving it the potential to free up thousands of NHS eye clinic appointments4
Reading, UK, 22 January 2024 – Bayer today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation of EYLEA® 8mg (aflibercept 8 mg) in adults for the treatment of neovascular (wet) age-related macular degeneration (nAMD), and visual impairment due to diabetic macular oedema (DMO).The authorisation is based on positive data from the phase III study, PULSAR, in nAMD and the phase II/III study, PHOTON, in DMO. Aflibercept 8 mg is expected to be available from early February to NHS patients.
nAMD is a chronic progressive eye disease, predominantly affecting older people and is a major cause of blindness worldwide.1,2 It often presents with acute visual symptoms such as sudden onset blurred or distorted central vision. DMO is also characterised by loss of central vision and is the most common cause of sight loss in people with Type 2 Diabetes.3 Treatment for both conditions generally consists of regular injections into the eye.
Cathy Yelf, Chief Executive of the Macular Society, commented, “The news of another longer-lasting treatment for nAMD is very welcome. Anti-VEGF therapies have been a major breakthrough in saving sight, but we know that the frequent injections are a real burden for patients and expensive for the NHS. Having a new treatment that both increases options and the time between hospital visits will improve the lives of patients and benefit the NHS.”
According to NHS England, ophthalmology is currently the busiest outpatient speciality in secondary care and comprises nearly 10% of the entire NHS waiting list.5,6 The NHS England waiting list for hospital treatment currently stands at 7.8 million.7
“Macular diseases such as nAMD and DMO pose a very real threat to the eyesight of patients, leading to blindness if untreated. Treatment with injections into affected eyes carried out in ophthalmology clinics can help preserve vision,” said Professor Sobha Sivaprasad, of Moorfields Eye Hospital NHS Foundation Trust, “the results of the PULSAR and PHOTON clinical trials show that the vast majority of patients being treated with aflibercept 8 mg were able to extend the time between injections to up to five months, while maintaining the expected treatment effect of a lower, more frequent dose of aflibercept 2 mg.”
The phase III PULSAR and phase II/III PHOTON studies compared aflibercept 8 mg with a lower 2 mg dose in patients with nAMD and DMO respectively. At week 48, both studies met their primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) of aflibercept 8 mg with two extended dosing regimens (every 12 and 16 weeks) compared to aflibercept 2 mg dosed every 8 weeks, following initial monthly doses. In these studies, the safety profile of aflibercept 8 mg was consistent with the well-established safety profile of aflibercept 2 mg.
The rates of intraocular inflammation (IOI) for aflibercept 8 mg compared to aflibercept 2 mg were 0.7% versus 0.6% in PULSAR and 0.8% versus 0.6% in PHOTON. No severe cases of IOI were observed. There were no clinically relevant differences in intraocular pressure between the treatment groups. In both trials, there were no cases of endophthalmitis, retinal vasculitis and no new safety signals through week 48.
“Bayer has a long-standing commitment to improving patient access to macular services. Over the past 10 years we have worked jointly with the NHS to enhance and refurbish macular clinics and provide additional diagnostic technology,” said Dr Joep Hufman, MD, Medical Director Bayer UK & Ireland. “After extensive research programmes, UK patients will be among the first in the world to have access to aflibercept 8 mg, which has great potential to eliminate the need for thousands of clinical appointments every year.”
Reporting of side effects:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to Bayer plc. Tel.: 0118 206 3500, Fax: 0118 206 3703, Email: pvuk@bayer.com
