Bayer gains MHRA authorisation for macular condition treatment

Bayer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for Eylea 8mg in adults for two macular conditions and extending treatment intervals.

Eylea 8mg (aflibercept 8mg) has received marketing authorisation for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).

The anti-vascular endothelial growth factor treatment has been authorised for the extension of treatment intervals up to five months between infections, after three monthly loading doses.

The authorisation has been based on the results of the phase III PULSAR study in nAMD and the phase II/III study, PHOTON in DMO.

Dr Joep Hufman, medical director of Bayer UK and Ireland, shared: “After extensive research programmes, UK patients will be among the first in the world to have access to aflibercept 8mg, which has great potential to eliminate the need for thousands of clinical appointments every year.”

The treatment is expected to be available to NHS patients from early February.

Bayer pointed out that ophthalmology is currently the busiest outpatient speciality in secondary care, comprising nearly 10% of the NHS waiting list.

Calling the news of another longer-lasting treatment for nAMD “very welcome,” Cathy Yelf, chief executive of the Macular Society, commented: “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,” she said.

The PULSAR and PHOTON studies compared aflibercept 8mg with a lower 2mg 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 of aflibercept 8mg with two extended dosing regimens of every 12 and 16 weeks, compared to aflibercept 2mg dosed every eight weeks, following initial monthly doses.

The safety profile of aflibercept 8mg was found to be consistent in the studies with the safety profile of aflibercept 2mg.

The rates of intraocular inflammation for aflibercept 8mg compared to aflibercept 2mg were 0.7% versus 0.6% in PULSAR and 0.8% versus 0.6% in PHOTON.

No severe cases of intraocular inflammation were observed and there were no clinically relevant differences in intraocular pressure between the treatment groups, Bayer shared. Both trials reported no cases of endophthalmitis, retinal vasculitis and no new safety signals through week 48.

Professor Sobha Sivaprasad, of Moorfields Eye Hospital NHS Foundation Trust, reflected on the “very real threat” macular diseases such as nAMD and DMO can pose to patient’s eyesight, adding: “Treatment with injections into affected eyes carried out in ophthalmology clinics can help preserve vision.”

Sivaprasad commented: “The results of the PULSAR and PHOTON clinical trials show that the vast majority of patients being treated with aflibercept 8mg 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 2mg.”