NICE nod for new Eylea indication

The National Institute for Health and Care Excellence (NICE) has issued a final positive recommendation for Bayer’s Eylea as a treatment for adults for the treatment of visual impairment due to myopic chorodial neovascularisation.

Myopic CNV is a common vision-threatening complication of myopia and pathological myopia (severe near-sightedness).

Pathologic myopia affects up to three percent of the population, of which myopic CNV occurs in approximately five-10 percent of patients. The long term prognosis is poor, with 90 percent of patients reaching the threshold for ‘legal blindness’ within five years of diagnosis.

Eylea (aflibercept solution for injection) is an anti-VEGF treatment designed to block the growth of new blood vessels and decrease vascular permeability to rapidly deliver sustainable improvements in vision, while offering patients and healthcare professionals a predictable dosing programme.

In the Phase III MYRROR study, patients with mCNV given one initial dose, with re-treatment only in case of persistence or recurrence of the CNV, achieved sustained and clinically meaningful visual improvements over the entire observation period of 48 weeks, with 50 percent of aflibercept patients gaining ≥15 letters from baseline.

Overall, patients in the Eylea group received a median of 2 injections during weeks zero to eight of the study, and a median of zero shots 12 to 44, and the treatment was well tolerated with a safety profile similar to previous studies in other indications.

"We are pleased that NICE has recognised the value of Eylea and the benefits that it can bring to patients and the clinical community," said Lars Bruening, Bayer UK/Ireland’s chief executive. "At Bayer we are committed to ensuring all eligible patients have access to Eylea in line with the market authorisation so it is great news for patients with mCNV in England and Wales who will have access to this effective treatment as soon as adopted by policy makers."

As well as for myopic CNV, Eylea is also licensed in the UK for the treatment of wet age-related macular degeneration, visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) and visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO).