Source: Personal communication (Novartis)
Area: News
Novartis Pharmaceuticals UK Limited is advising customers of a forthcoming change to the injection needle supplied in packs of ranibizumab (Lucentis®).
The needle supplier is being switched from Becton & Dickinson to B.Braun at the end of December 2012. Customers may therefore notice a difference in the appearance of the injection needle and the outer packaging of the needle. Novartis has stressed that the rest of the pack will remain the same, including the filter needle.
Author: NeLM - Ophthalmology
EMA issues Questions and Answers on the use of phosphates in eye drops
Source: European Medicines Agency
Area: News
The European Medicines Agency (EMA) has completed an assessment of the use of phosphate buffers in medicinal products given as eye drops and examined whether these can cause corneal calcification. The Agen…
EMA issues Questions and Answers on the use of phosphates in eye drops
Source: European Medicines Agency
Area: News
The European Medicines Agency (EMA) has completed an assessment of the use of phosphate buffers in medicinal products given as eye drops and examined whether these can cause corneal calcification. The Agen…
SMC accepts restricted use of ranibizumab (Lucentis®) for diabetic macular oedema, following resubmission
Source: Scottish Medicines Consortium (SMC)
Area: Evidence > Drug Specific Reviews
Following a resubmission, the Scottish Medicines Consortium (SMC) has accepted ranibizumab (Lucentis®) for restricted use within NHS Scotland for the treatment of …
Horizon scanning: Aflibercept (EYLEA) filed for approval in EU for treatment of macular oedema following central retinal vein occlusion
Source: PharmaLive
Area: News
Bayer HealthCare has submitted an application for marketing authorisation in the EU for aflibercept (EYLEA) injection for the treatment of macular oedema following central retinal vein occlusion.
The submission…
Horizon scanning: Aflibercept (EYLEA) filed for approval in EU for treatment of macular oedema following central retinal vein occlusion
Source: PharmaLive
Area: News
Bayer HealthCare has submitted an application for marketing authorisation in the EU for aflibercept (EYLEA) injection for the treatment of macular oedema following central retinal vein occlusion.
The submission is based on data from the phase III COPERNICUS and GALILEO studies which had as the primary efficacy endpoint, the proportion of patients who gained at least 15 ETDRS letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline on the ETDRS visual acuity charts. The aflibercept 2mg monthly group was reported to be statistically significantly superior to the sham control group for this endpoint and the effects were largely maintained until week 52.
Aflibercept is a recombinant fusion protein consisting of portions of human vascular endothelial growth factor (VEGF) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration, which was recently …
Bayer announces UK launch of aflibercept (Eylea®) for wet AMD
Source: Personal communication, PharmaTimes
Area: News
Bayer has announced the UK launch of aflibercept (Eylea®) solution for injection, for the treatment of wet age-related macular degeneration. According to the SPC, treatment is initiated with one …
Final draft guidance from NICE does not support use of fluocinolone acetonide intravitreal implant for chronic diabetic macular oedema
Source: NICE
Area: News
In its Final Appraisal Determination (FAD), NICE does not support the use of fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of chronic diabetic macular oedema (DMO) considered insufficiently responsive …
Omega 3 fatty acids for preventing or slowing the progression of age-related macular degeneration
Source: Cochrane
Area: Evidence > Drug Specific Reviews
Background
Evidence from animal models and observational studies in humans has suggested that there is an inverse relationship between dietary intake of omega 3 long-chain polyunsaturated…
Horizon scanning: EU approves marketing authorisation for aflibercept (EyleaT) for the treatment of wet age-related macular degeneration
Source: BioSpace
Area: News
The European Commission has granted marketing authorisation for aflibercept (EyleaT) injection, for the treatment of neovascular (wet) age-related macular degeneration (AMD).
According to the Summary of Product …
Exocin® (ofloxacin) 3mg/mL eye drops – Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.4 of the SPC has been revised to include information about elderly patients and women being more sensitive to QTc-prolonging medications, includ…
Ganfort (bimatoprost with timolol maleate) eye drops – Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.2 of the Ganfort (bimatoprost 0.3mg with timolol 5mg per 1 mL) eye drops SPC has been updated to include the following information on administrati…
SMC accepts nepafenac (Nevanac) for the reduction in the risk of postoperative macular oedema associated with cataract surgery
Source: Scottish Medicines Consortium (SMC)
Area: Evidence > Drug Specific Reviews
The Scottish Medicines Consortium (SMC) has accepted nepafenac (Nevanac®) for use in NHS Scotland, for the reduction in the risk of postoperative macular oedema as…
Pfizer communication on risk of serious increase in intraocular pressure with intravitreal injection of excess volume of pegaptanib sodium (Macugen®)
Source: Pfizer
Area: News
Pfizer has issued a communication about a potential for injecting an excess volume of pegaptanib sodium (Macugen®) intravitreally. This risk has been identified in a clinical trial and in clinical practice. Two cases have be…
Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration
Source: Ophthalmology
Area: News
According to data from the VIEW 1 and VIEW 2 studies published early online in Ophthalmology, and presented at the American Academy of Ophthalmology annual meeting, intravitreal aflibercept dosed monthly or every 2 mo…
Long term safety of ranibizumab in neovascular age-related macular degeneration: SECURE Study
Source: Ophthalmology
Area: News
The long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration has been assessed in a 24 month open-label, multicentre, phase IV extension study (SECURE).
…
Ocriplasmin (Jetrea®) approved in US for the treatment of symptomatic vitreomacular adhesion
Source: PharmaLive
Area: News
The FDA has approved ocriplasmin (Jetrea®) in the US for the treatment of symptomatic vitreomacular adhesion, a progressive sight threatening condition, making it the first pharmacological agent to be approved for this i…
Three year outcomes and the need for prolonged frequent treatment in the READ-2 study of ranibizumab for diabetic macular oedema
Source: Arch Opthalmol
Area: News
The ‘Ranibizumab for Edema of the Macula in Diabetes’ (READ-2) study is a phase II randomised clinical trial conducted at 14 sites in the US that involved patients with diabetic macular oedema assigned to intraocular …
NICE publishes new draft guidance on ranibizumab for diabetic macular oedema after rapid review
Source: NICE
Area: News
Draft guidance from NICE has recommended ranibizumab as an option for treating visual impairment caused by diabetic macular oedema (DMO). NICE conducted a rapid review of the original guidance, published in November 2011, becau…
Intravitreal bevacizumab for inflammatory choroidal neovascularisation secondary to punctate inner choroidopathy
Source: London and South East Regional Medicines Information Service
Area: Evidence > Reviews for Individual Funding Requests (IFRs)
Review completed for IFR panel September 2012 on Intravitreal bevacizumab for inflammatory choroidal neovascularis…