Author: NeLM - Ophthalmology

Lucentis (ranibizumab) 10 mg/ml solution for injection – Novartis Pharmaceuticals UK Ltd – Revised SPC

Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.4 Special warnings and precautions for use has been updated to include the information that systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors.
 
Please see link to the SPC for full prescribing information
 

Ocriplasmin (Jetrea®) approved in the EU for vitreomacular traction

Source: BioSpace
Area: News
According to BioSpace, the European Commission has approved ocriplasmin (Jetrea®) for the treatment of vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns. This follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued in January 2013 (please see a related NeLM report via the link below for further details, including a discussion of the available efficacy data and the drug’s mechanism of action).

Latanoprost 50mcg/ml eye drops – Pfizer Limited – Revised SPC

Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.4 Special warnings and precautions for use has been updated with ‘congenital glaucoma’ removed from this section.
 
Section 4.8 Undesirable effects has also been updated to include some rare and very rare ocular side effects, including iritis/uveitis (the majority of reports in patients with concomitant predisposing factors); macular oedema; symptomatic corneal oedema and erosions; periorbital oedema; misdirected eyelashes sometimes resulting in eye irritation; extra row of cilia at the aperture of the meibomian glands (distichiasis) and (Read more...)

SMC accepts restricted use of bimatoprost 0.3mg/mL preservative-free eye drops (Lumigan UD®)

Source: Scottish Medicines Consortium (SMC)
Area: Evidence > Drug Specific Reviews
The Scottish Medicines Consortium (SMC) has accepted restricted use of bimatoprost 0.3mg/mL preservative-free eye drops (Lumigan UD®) in NHS Scotland for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).
 
The product is restricted to use in patients who have proven sensitivity to the preservative benzalkonium chloride.

CADTH rapid response report: Review of effectiveness and safety of fusidic acid for ophthalmic infections

Source: Canadian Agency for Drugs and Technologies in Health (CADTH)
Area: News
This Canadian review examined the clinical effectiveness, safety and economic literature on fusidic acid to help inform a funding decision.
 
The evidence on the clinical effectiveness and safety of fusidic acid for eye infections was limited to three lower quality RCTs which noted the following:
 
. Short term (7 day) treatment with topical fusidic acid resolved clinical signs and symptoms of conjunctivitis or chronic blepharitis in 76% to 91% of patients compared to 73% to 93% of (Read more...)

NICE issues final guidance supporting the use of ranibizumab for diabetic macular oedema (TA 274)

Source: NICE
Area: Evidence > Guidelines
NICE has issued final guidance (TA 274) supporting the use of ranibizumab for treating visual impairment due to diabetic macular oedema (DMO) only if:
 
. the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and
. the manufacturer provides ranibizumab with the discount agreed in the patient access scheme (as revised in 2012).
 
NICE conducted a rapid review of the original guidance (TA 237; November 2011) because the manufacturer submitted a revised Patient Access Scheme, together (Read more...)

NICE costing template for its guidance on ranibizumab for diabetic macular oedema (TA 274)

Source: NICE
Area: News
NICE has published a costing statement to accompany its guidance on the use of ranibizumab for treating visual impairment due to diabetic macular oedema (TA 274).
 
The costing report calculates that: “the annual cost associated with implementing this recommendation is estimated as £41,000 for a population of 100,000 based on the standard assumptions in the model once a steady state is reached. There are also anticipated to be non-recurrent costs from treating the prevalent population on implementation of the guideline of around £341,000. It is (Read more...)

Systematic Review: Comparative effectiveness of treatments for open-angle glaucoma

Source: Ann Intern Med
Area: News
The Annals of Internal Medicine has featured a systematic review comparing the effectiveness of medical, laser, and surgical treatments in adults with open-angle glaucoma with regard to decreasing intraocular pressure and preventing optic nerve damage, vision loss, and visual impairment.
 
Data from a total of 23 randomised trials, observational studies and systematic reviews were included in this analysis.
 
The researchers reported that high-level evidence suggests that medical, laser, and surgical treatments decrease intraocular pressure and that medical treatment and trabeculectomy reduce the (Read more...)

Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein

Source: Cochrane
Area: Evidence > Drug Class Focused Reviews
Background
Branch retinal vein occlusion (BRVO) is one of the most common occurring retinal vascular abnormalities. The pathogenesis of BRVO is thought to involve both retinal vein compression and damage to the vessel wall, possibly leading to thrombus formation at sites where retinal arterioles cross retinal veins. The most common cause of visual loss in patients with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss and improve visual acuity (Read more...)

Anti-vascular endothelial growth factor for macular oedema

Source: Cochrane Library
Area: Evidence > Drug Class Focused Reviews
Background
Branch retinal vein occlusion (BRVO) is one of the most common occurring retinal vascular abnormalities. The pathogenesis of BRVO is thought to involve both retinal vein compression and damage to the vessel wall, possibly leading to thrombus formation at sites where retinal arterioles cross retinal veins. The most common cause of visual loss in patients with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss and improve visual (Read more...)

Phase III study: Twelve-Month comparison of 0.5 mg or 2.0 mg ranibizumab in patients with wet age-related macular degeneration (HARBOR)

Source: Ophthalmology
Area: News
Several small studies have suggested the potential of enhanced efficacy with higher 2mg dosing of ranibizumab. The HARBOR study was a 24-month, phase III, randomised, multicentre, double-masked study which evaluated the 12-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly and on an as-needed (PRN) basis in treatment-naïve patients (n=1,098) aged over 50 years with subfoveal neovascular age-related macular degeneration (wet AMD).
 
Noninferiority (NI) tests with a prespecified NI margin of 4 letters comparing the 0.5 mg PRN with the (Read more...)

NICE issues costing statement on fluocinolone acetonide intravitreal implant for the treatment of chronic diabetic macular oedema (TA 271)

Source: NICE
Area: News
NICE has published a costing statement to accompany its guidance on fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of chronic diabetic macular oedema (DMO) considered insufficiently responsive to available therapies (TA 271).
 
Because fluocinolone acetonide is not recommended for routine use within the NHS, NICE do not anticipate a significant impact on NHS resources.
 
See links below for further details.

NICE issues final guidance on fluocinolone acetonide intravitreal implant for the treatment of chronic diabetic macular oedema (TA 271)

Source: NICE
Area: Evidence > Drug Specific Reviews
NICE has issued final guidance that does not support the use of fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of chronic diabetic macular oedema considered insufficiently responsive to available therapies (TA 271).
 
The Committee noted that fluocinolone acetonide intravitreal implants do not provide enough benefit to patients to justify their high cost.
 
See links below for further details.

NETAG issues appraisal and recommendation on aflibercept for AMD

Source: NETAG
Area: Evidence > Drug Specific Reviews
The NHS North East Treatment Advisory Group (NETAG) has undertaken an appraisal of aflibercept (Eylea®) within its licensed indication for the management of neovascular (wet) age-related macular degeneration (AMD). The Group recommends its use, within its licensed indication, for the treatment of newly diagnosed and untreated wet AMD. It does not however recommend its use for the same episode of AMD refractory to treatment with other biological therapies such as ranibizumab. This recommendation is contingent on a maximum cost per aflibercept dose (Read more...)

CHMP does not recommend idebenone (Raxone®) for the treatment of Leber’s hereditary optic neuropathy

Source: European Medicines Agency
Area: News
The Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the orphan medicine idebenone (Raxone®), intended for the treatment of patients with Leber’s hereditary optic neuropathy (LHON), an inherited disease characterised by progressive loss of sight.
 
The company presented the results from one main randomised, placebo-controlled study involving 85 patients with LHON whose symptoms started in the previous five years. The main measure of effectiveness was the change in vision after (Read more...)

CHMP recommends approval of ocriplasmin (Jetrea®) for vitreomacular traction

Source: European Medicines Agency
Area: News
The Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for ocriplasmin (Jetrea®) for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ?400 microns. VMT is an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. It is estimated to affect between 250,000 to 300,000 patients in Europe.
 
Ocriplasmin is a recombinant form of human plasmin, administered as a single intravitreal injection. It (Read more...)

NICE final draft guidance supports use of ranibizumab for diabetic macular oedema

Source: NICE
Area: News
In its Final Appraisal Determination, NICE is supporting the use of 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, because the manufacturer submitted a revised Patient Access Scheme, together with updated analyses showing the drug’s superior relative effect among a sub-group of people with DMO.
 
The draft guidance states that ranibizumab is now recommended as an option for treating visual impairment due to diabetic macular oedema (Read more...)