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Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending the European Union approval of its wet age-related macular degeneration (AMD) agent, Lucentis (ranibizumab).
This is welcome news for Novartis and for retinologists who have been waiting to introduce the new product into their clinics, particularly because Lucentis is the first drug that has been shown to improve vision in patients with wet AMD.
The positive opinion, issued on 17 November, follows approvals for Lucentis in Switzerland, India and the US and is based on three Phase III clinical trials, including two pivotal studies that were published in the October 2006 issue of the New England Journal of Medicine.
Lucentis has also been granted priority review in Canada. This means that it could potentially be approved within 200 days of the Canadian regulatory agency, Health Canada, receiving the file.
EC-5000 gets FDA seal of approval
NIDEK has received FDA approval for its EC-5000 excimer laser for the treatment of hyperopia and hyperopic astigmatism.
The system has been approved to treat hyperopia and hyperopic astigmatism of +0.50 to +5.00 D sphere up to 2.00 D cylinder, in addition to the current approved range for myopia and myopic astigmatism. Six-month follow-up safety and efficacy results for the system showed that 69% of 291 eyes were within ±0.5 D and 93% within ±1.0 D of correction. Sixty percent achieved 20/20 or better uncorrected visual acuity (UCVA), 86% 20/25 or better UCVA and 99% achieved 20/40 or better UCVA.
In addition to the FDA approval of the EC-5000, NIDEK is also developing its own custom ablation and wavefront technology platform.
Survey says Avastin is safe
Results of an internet based survey suggest that the off-label use of bevacizumab (Avastin), as a treatment for neovascular and exudative disease, is safe, according to results published in the November issue of the British Journal of Ophthalmology.
Anne Fung, MD, of the Pacific Eye Associates and co-researchers from the University of Miami and Tufts University Medical Center, US, created an internet-based survey to identify adverse events associated with intravitreal bevacizumab treatment. The survey was e-mailed to the international vitreoretinal community and rates of adverse events were calculated from participant response.
A total of 70 centres in 12 countries responded, reporting on 7,113 injections given to 5,228 patients. Adverse events reported included corneal abrasion, lens injury, endophthalmitis, retinal detachment, inflammation or uveitis, cataract progression, acute vision loss, central retinal artery occlusion, subretinal haemorrhage, retinal pigment epithelium tears, blood pressure elevation, transient ischaemic attack, cerebrovascular accident and death. Rates of these adverse events never exceeded 0.21%.
From the survey, researchers discovered that no drug-related adverse events were observed beyond the normal level of incidence seen in control groups in current anti-VEGF trials. They concluded that, although these are only short-term results, bevacizumab does appear to be a safe treatment for neovascular and exudative ocular disease.
The long awaited trial to commence: Visudyne + Lucentis
Novartis has announced that it is to conduct a trial exploring a combination of therapies, Visudyne (verteporfin) and Lucentis (ranibizumab), as a treatment for wet age-related macular degeneration (AMD).
The DENALI trial will compare the safety, efficacy and impact of retreatment rates of the photodynamic therapy (PDT) Visudyne when used in conjunction with the vascular endothelial growth factor (VEGF) inhibitor, Lucentis (ranibizumab), versus ranibizumab monotherapy in subjects with subfoveal choroidal neovascularization (CNV) secondary to wet AMD.