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Eylea Listed for BRVO

mivision | 30 January 2017
Eylea (Aflibercept) has been included on the Pharmaceutical Benefits Scheme (PBS) from 1 December 2016, for the treatment of Australians diagnosed with visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO).

Professor Paul Mitchell, Head of Ophthalmology at Sydney’s Westmead Hospital welcomed the inclusion, saying it would provide ophthalmologists with a new treatment option to address this sometimes sudden and frightening condition.1

It is estimated there are over 90,000 Australians living with BRVO,2,3 a condition that can cause vision loss or blurring in part or all of one eye and may happen suddenly or become worse over several hours or days.4,1 In some cases there can be sudden and severe loss of vision.1

In BRVO the blood supply becomes restricted to the eye (known as retinal ischaemia), which stimulates the release of VEGF. The up-regulation of VEGF promotes extra blood vessel growth in the eye, which can destabilise the tight junctions between the arteries and veins, breaking down the blood retina barrier. This increased permeability in the vessels in the eye results in retinal oedema (fluid and swelling) and neovascularisation (the formation of new blood vessels in abnormal places).1

Registration of Eylea was supported by VIBRANT, a pivotal phase III trial which involved an active comparator (laser therapy).5 The study showed that 52.7 per cent of patients who received Eylea 2 mg every four weeks gained at least 15 letters (three lines on the vision chart) in vision from baseline at week 24, the primary endpoint of the study. This compares with 26.7 per cent of patients in the laser group (P < 0.001) who had the same gain.5 Additionally, patients who received Eylea 2 mg every four weeks achieved a 17.0 letter mean improvement over baseline in best-corrected visual acuity (BCVA) compared with a 6.9 letter mean improvement in patients who received laser (P < 0.0001).5 At week 24, the dosing interval was extended to every eight weeks,6 and anatomic outcomes were maintained with sustained visual acuity over 52 weeks.6

The only serious ocular adverse event observed in the VIBRANT study was an occurrence of traumatic cataract (1.1 per cent) in the Eylea group.6 The incidence of arterial thromboembolic events as defined by the Antiplatelet Trialists' Collaboration (APTC) criteria in the VIBRANT study was 0 per cent (zero out of 91) in patients treated with EYLEA compared with 2.2 per cent (two out of 92) in the control group.1

Professor Mitchell described the results as encouraging. “While in some cases BRVO may come on gradually, it can also sometimes impact vision in a matter of days or even hours with varying degrees of severity. It is therefore encouraging to see that the trial results demonstrated efficacy with both perfused and non-perfused cases.5 With millions of Australians living with risk factors for BRVO, particularly chronic hypertension, it’s important for clinicians to reduce patient risk while ensuring that the disease is detected early and treated promptly,” he said.

Eylea was previously PBS listed for the treatment of neovascular (wet) age-related macular degeneration (wetAMD), diabetic macular oedema and vision loss due to macular oedema secondary to central retinal vein occlusion.7 For the treatment of visual impairment due to macular oedema secondary to BRVO, Eylea is initiated with one injection per month for three consecutive months. After the first three monthly injections, the treatment interval may be adjusted based on visual and/or anatomic outcomes.8

Important Safety Information

A total of 3102 patients treated with Eylea constituted the safety population in eight Phase III studies. Amongst those, 2501 patients were treated with the recommended dose of 2 mg. Serious adverse reactions related to the injection procedure have occurred in less than 1 in 2400 intravitreal injections with EYLEA and included endophthalmitis, retinal detachment, cataract traumatic, cataract, vitreous detachment and intraocular pressure increased.8

The most frequently observed adverse reactions (in at least 5 per cent of patients treated with Eylea) were conjunctival haemorrhage (25.0 per cent), visual acuity reduced (11.1 per cent), eye pain (10.2 per cent), cataract (7.6 per cent), intraocular pressure increased (7.5 per cent), vitreous detachment (7.4 per cent), and vitreous floaters (6.9 per cent).8

The complete list of precautions and adverse events is available with the full product information at www.ebs.tga.gov.au.

References
1. American Academy of Ophthalmology. Branch Retinal Vein Occlusion (BRVO) Symptoms. Retrieved from https://www.aao.org/eye-health/diseases/branch-retinal-vein-occlusion-symptoms
2.Australian Bureau of Statistics. Quarterly Population Estimates (ERP), by State/Territory, Sex and Age. Retrieved from http://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/3235.02015?OpenDocument
3. Mitchell.P, Smith. W, Chang. A. Prevalence and associations of retinal vein occlusion in Australia. The Blue Mountains Eye Study. Arch Ophthalmol. 1996 Oct; 114(10): 1243–1247.
4. EYLEA Product Information. Retrieved from http://www.bayerresources.com.au/resources/uploads/PI/file10294.pdf
5. Campochiaro, Peter A. et al. Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion. Ophthalmology , Volume 122 , Issue 3 , 538 – 544.
6. Clark, W. Lloyd et al.“Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion,“ Ophthalmology , Volume 123 , Issue 2 , 330 - 336
7. Australian Government Department of Health Pharnaceutical Benefits Scheme. Retrieved from https://www.pbs.gov.au/medicine/item/10505X-2168D
8. EYLEA Product Information. Retrieved from http://www.

' While in some cases BRVO may come on gradually, it can also sometimes impact vision in a matter of days or even hours with varying degrees of severity.\ '