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Retina Care

The practice of Hadi Zambarakji

Patient Information

Microincision phacoemulsification cataract surgery is usually performed under topical anaesthesia, but an anaesthetist may be needed is sedation is required. Cataract surgery is performed at the Hospital of St. John and St. Elizabeth, Nuffield Health – The Holly Private Hospital and the Spire London East Hospital. Please click on this link for post-operative instructions and general advice after phacoemulsification cataract surgery. More information about our specialist services including cataract surgery can be found in our cataract surgery leaflet.

You should receive as part of the cataract package a two-sided A4 chart remember when to administer your eye drops. Should you need another one, please click the link to the post-operative eye drops schedule for surgery done at the Spire London East (Monday), Nuffield Health – The Holly (Thursday), and the Hospital of St. John and St. Elizabeth (Friday). A summary of the standard post operative eye drops schedule is listed in this document.

Vitreoretinal surgery is performed at the Hospital of St. John and St. Elizabeth. Most cases are performed as a day case, in particular if surgery is performed in the morning, however an overnight stay is possible, in particular if a patient does not live locally. Surgery is usually performed under local anaesthesia with mild sedation if the latter considered necessary. Mr. Zambarakji works with a skilled and caring team of Nurses and Consultant Anaesthetist who will attend to your needs and ensure you have a satisfying experience. Some patients will be asked to posture after vitrectomy surgery. Please click on the link for post-operative instructions and general advice following vitrectomy surgery. We recommend hiring a posturing device for two weeks following surgery if your consultant has recommended post operative face down posturing. Please click on the link to Vitrectomy recovery rental centre. Alternatively, a selection of smaller face down pillows can be purchased from Amazon here and here.

For patients undergoing any form of ophthalmic surgery as a day case, please click on the link for general advice about driving, clothing, medications etc.

Intravitreal therapy is administered for the treatment of macular degeneration, diabetic retinopathy and retinal vascular venous occlusions, amongst other less frequent indications such as high myopia with choroidal neovascularisation. There are different ways of delivering drugs to the retina, which are summarised in a short article I had written for a previous edition of the Holly Private Hospital GP newsletter, this can be accessed on page 8 of the GP newsletter. Please note that I do not recommend the use of Ocriplasmin (Jetrea) for symptomatic vitreomacular attachment (VMA) and small macular holesbecause of the reported cases of vision loss as well as increased risk of retinal detachment.

Avastin vs. Eylea or Lucentis for wet age-related macular degeneration. This article published in the British Medical Journal gives support for the use of Avastin (Bevacizumab), a much less expensive option for the treatment of wet age-related macular degeneration by intravitreal injection. A group of clinical commissioning groups won a court battle against the pharmaceutical industry thus allowing the use of Avastin. By way of comparison, the hospital charge for the administration of Avastin (Bevacizumab) is £535 compared to £1,350 for Eylea (Aflibercept) and £1,525 for Lucentis (Ranibizumab) (excluding the surgeon fee). These figures are for Nuffield Health – The Holly private Hospital and are correct at the time of writing – Jan 2025 (these may differ at other institutions). Numerous trials have demonstrated that Bevacizumab is non-inferior to Ranibizumab in the treatment of neovascular AMD and that both have similar safety profiles. The decision to use one drug over the other is multifactorial but the additional billions spent on licence medications does not make economic sense based on cost effectiveness models. Furthermore, a recent review and meta-analysis investigating the effect and protocol of anti-vascular endothelial growth factor treatment on wet AMD concluded the following: The superiority remains unclear between Ranibizumab (Lucentis) and intravitreal Bevacizumab (Avastin) in the treatment of neovascular AMD. Intravitreal Aflibercept (Eylea) dosed every 2 months required fewer injection times, but produced similar efficacy as monthly Ranibizumab. The current availability of biosimilar drugs (Ongavia and Byooviz for Ranibizumab) has resulted in much cheaper alternatives to Lucentis (Hospital fees £900-£1,100).

Avastin (Bevacizumab) for diabetic macular oedema (DMO) and other conditions that are complicated by macular oedema: A meta-analysis published in the British Medical Journal in 2019 looked at the efficacy and safety of intravitreal Bevacizumab, Ranibizumab and Aflibercept for patients with choroidal neovascular age-related macular degeneration (cn-AMD), diabetic macular oedema (DMO), macular oedema due to retinal vein occlusion (RVO-MO) and myopic choroidal neovascularisation (m-CNV).

This study is a systematic review which means that it has put together the results of multiple randomised controlled trials to give a meaningful answer to the question. Vision gain was not significantly different in patients with cn-AMD, DMO, RVO-MO and m-CNV treated with Bevacizumab versus Ranibizumab. Similarly, vision gain was not significantly different between cn-AMD patients treated with Aflibercept versus Ranibizumab. Patients with DMO treated with Aflibercept experienced significantly higher vision gain at 12 months than patients receiving Ranibizumab or Bevacizumab; however, this difference was not significant at 24 months. Rates of systemic serious harms were similar across anti-VEGF agents.

The study concluded that intravitreal Bevacizumab was a reasonable alternative to Ranibizumab and Aflibercept in patients with cn-AMD, DMO, RVO-MO and m-CNV. The only exception was for patients with DMO and low visual acuity where treatment with Aflibercept was associated with significantly higher vision gain than Bevacizumab or Ranibizumab at 12 months; but the significant effects were not maintained at 24 months.


Faricimab (Vabysmo) for diabetic macular oedema (DMO):
 Faricimab is a novel anti-VEGF injection (NICE approved – July 2022) that works in a similar way to Aflibercept and Ranibizumab, but it also targets the Angiotensin pathway. Clinical evidence for Faricimab compared with Aflibercept came from 2 randomised controlled trials that compared Faricimab with Aflibercept. After the initial loading doses, Aflibercept was given every 8 weeks and Faricimab was administered as needed, with a maximum gap of 16 weeks between injections (a personalised treatment interval). The primary outcome measure was the mean change in best corrected visual acuity and the evidence suggested that both treatments were similarly effective and had similar adverse events.

Faricimab (Vabysmo) for wet age-related macular degeneration: Clinical evidence for Faricimab compared with Aflibercept came from 2 clinical trials. After the initial loading doses, Aflibercept was given every 8 weeks and Faricimab was administered every 8, 12 or 16 weeks. The evidence suggested that both treatments were similarly effective and had similar adverse events. A key advantage of Vabysmo is its more flexible dosing regimen, extending the time between treatments and reducing the number of injections to the eye.

Brolicuzumab (Beovu) for diabetic macular oedema (DMO) and wet age-related macular degeneration: Brolicuzumab is another anti-VEGF injection that works in a similar way to Aflibercept and Ranibizumab. Brolicuzumab has been recommended as an option for treating visual impairment due to diabetic macular oedema and wet age-related macular degeneration. Clinical evidence for Brolicuzumab came from randomised controlled trials. For DMO, Aflibercept was administered 5 times during the loading phase (once every 4 weeks), then every 8 weeks during the maintenance phase. Brolicuzumab was administered 5 times during the loading phase (once every 6 weeks), then every 12 weeks during the maintenance phase. The evidence suggested that both treatments were similarly effective. Clinical trial evidence in eyes with wet age-related macular degeneration also shows that Brolicuzumab provides similar overall health benefits to Aflibercept and Ranibizumab, and is similarly safe. The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection monthly for the first three doses, followed by 6 mg (0.05 mL) by intravitreal injection once every 8 to 12 weeks.

Most importantly, intraocular inflammation and retinal vasculitis are potential unwanted adverse events with Brolicuzumab. Symptoms of endophthalmitis or retinal vasculitis can include: red eye, sensitivity to light, eye pain that gets worse after injection, blurred vision/vision loss. The above potential side effect profile of Brolucizumab has made this a much less attractive treatment option, in particular as Vabysmo (Faricimab) and Eylea HD (Aflibercept 8 mg) are currently available treatment options.

Eylea HD (Aflibercept 8 mg) is a 4 molar dose of Aflibercept in a volume of 0.07 ml compared to 0.05 ml for Eylea 2 mg for neovascular macular degeneration (nAMD): Intravitreal Aflibercept 8 mg could improve treatment outcomes and provide sustained disease control in patients with neovascular age-related macular degeneration (nAMD), with extended dosing compared with Aflibercept 2 mg.

PULSAR is a phase 3, randomised trial conducted across 223 sites worldwide. Adults with nAMD were randomised to Aflibercept 8 mg every 12 weeks (8q12), Aflibercept 8 mg every 16 weeks (8q16), or Aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups. Aflibercept 8q12 and 8q16 showed non-inferior visual acuity gains versus Aflibercept 2q8 and the incidence of ocular adverse events in the study eye was similar across groups. Aflibercept 8 mg therefore shows efficacy and safety with extended dosing intervals, therefore reducing the number of injections and the number of visits to the clinic.

Eylea HD (Aflibercept 8 mg) compared to 0.05 ml for Eylea 2 mg for diabetic macular oedema (DMO): PHOTON was a randomised phase 2/3 trial performed at 138 hospitals and specialty retina clinics in seven countries. Eligible patients were adults aged 18 years or older with type 1 or 2 diabetes and centre-involved DMO. Patients were randomly assigned to intravitreal Aflibercept 2 mg every 8 weeks (2q8), Aflibercept 8 mg every 12 weeks (8q12), or Aflibercept 8 mg every 16 weeks (8q16), following initial monthly dosing. Aflibercept 8q12 and 8q16 demonstrated non-inferior visual acuity gains to Aflibercept 2q8. Aflibercept 8 mg therefore shows efficacy and safety with extended dosing intervals, therefore reducing the number of injections and the number of visits to the clinic.

Biosimilars: A biosimilar medicine (known as a ‘biosimilar’) contains a version of an active substance of an approved biological medicinal product, known as the reference product. Biosimilar development aims to establish similarity between the biosimilar and the reference product based on a comprehensive comparability process. This ensures the previously proven safety and efficacy of the reference product also applies to the biosimilar. Biosimilars are cheaper than the original drugs and are considered to be just as safe, effective, and high quality. 

The UK has three biosimilars to Lucentis, a drug used to treat eye conditions:  Ongavia (the first biosimilar to Lucentis to be available in the UK), Byooviz (Introduced in April 2023) and Ximluci (approved in 2023). I currently use both Byooviz and Ongavia.

Eylea has five biosimilars (https://www.drugs.com/medical-answers/eylea-have-biosimilar-3577184/): two that are designated as interchangeable (Opuviz and Yesafili) and three that are not interchangeable (AhzantiveEnzeevu and Pavblu).

An interchangeable biosimilar is a biologic product that can be automatically substituted for the reference product (in this case, Eylea) by your pharmacist. Your pharmacist will not need to contact the doctor to get an approval. It also means the reference biologic and the new biosimilar can be switched back and forth in a patient without a risk of changes in safety or effectiveness.

As of November 2023, biosimilars for Eylea (Aflibercept), specifically “Yesafili” produced by Biocon Biologics, have been approved in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). I am not currently using Yesafili but I expect that this be used fairly soon as part of our treatment options. 

 

 

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