pharmafileSeptember 25, 2017
Bayer has revealed that UK drug regulator NICE has given its final recommendation on blockbuster eye drug Eylea (aflibercept solution for injection) in the treatment of visual impairment due to myopic chorodial neovascularisation (mCNV), advising that it be made available to patients on the NHS in England and Wales.
The decision was based on Phase 3 trial data investigating the efficacy of a single initial injection of Eylea in patients with mCNV, with retreatment only given in the event the condition persisted of reoccurred. Over 48 weeks, the anti-VEGF treatment demonstrated "sustained and clinically meaningful visual improvements" in patients, with those taking the drug gaining 13.5 letters according to Best Corrected Visual Acuity testing, with 50% of aflibercept patients gaining ≥15 letters from baseline. Patients received an average of 2.0 injections over the first eight weeks of the study, and a total average of 3.0 over the full trial duration.
"We are pleased that NICE has recognized the value of Eylea and the benefits that it can bring to patients and the clinical community," Lars Bruening, Chief Executive of Bayer UK/Ireland, commented. "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."
This latest approval adds to the list of indications for which Eylea is available in the UK. This includes wet age-related macular degeneration (wAMD); visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) and visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO); and visual impairment due to diabetic macular edema (DMO).
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