New treatments in the pipeline

Wet AMD

New longer acting drugs:

• Beovu (brolucizumab) – Scottish Medicines Consortium and NICE have approved it for use for wet AMD patients. It is available in eye clinics now as a treatment option. People may only need an injection every 8-12 weeks.
• Vabysmo (faricimab) – new type of drug with dual action to address two different aspects of wet AMD. People may only need an injection every 3-4 months. It has been approved in England and Wales for use on the NHS.
• Susvimo (previously called the Port Delivery System) – a reservoir of Lucentis in the eye, which releases the drug gradually and can be re-filled every 6 months. It has been approved for use in the USA and is being considered by authorities in the UK but has had some technical problems so approval is delayed.
• High dose Eylea – a higher dose version of Eylea (8 mg) has just been approved. It will enable up to 16 weeks between injections.

Dry AMD

Researchers are looking at different ways to find treatments for AMD.

AMD is a complex disease that is still not fully understood. A popular approach for late-stage dry AMD treatments, also known as geographic atrophy (GA), is to look for drugs which will reduce inflammation in the macula, as inflammation causes damage and leads to sight loss. Another approach is to try and keep the photoreceptors alive for longer. Both approaches would slow the progress of the disease. 

The first two drugs have been approved for use in the USA. These drugs are called Syfovre and Izervay, and both look to reduce inflammation in the eye, which is believed to be involved in GA progression.  

Pegcetacoplan, produced by drugs company Apellis, will be marketed under the name Syfovre. It’s administered through eye injections either monthly or every other month. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) declined to approve Syfovre.

While the MHRA recognised the effect of Syfovre on slowing the rate of progression of GA, they were concerned about whether it meaningfully improved patients’ ability to see and manage daily tasks during the trial period. Syfovre has also been rejected for approval by European regulators. 

The second drug to be approved in the USA is avacincaptad pegol, marketed under the name Izervay and produced by Astellas. It has a similar action to Syfovre and is also an eye injection given monthly or every other month. This drug is currently being considered by the MHRA for approval in the UK. 

It's important to note that the aim of both drugs is to slow the speed of deterioration. Neither drug claims to restore vision. In clinical trials for Syfovre and Izervay, results showed that treatment slowed the spread of damage in the macula. However, those receiving treatment were found to have a higher risk of developing wet AMD. 

There are many other treatments for dry AMD and GA currently being investigated in clinical trials. Some trials are looking at new delivery methods, including oral tablets.

Biosimilars

When a drug’s patent expires it opens up the market to biosimilars. These are drugs that have a very similar make-up to the original drug, with no meaningful difference in how well they work or their safety. They are rigorously analysed and tested before being given a licence and give NHS clinicians choice and potentially significant cost savings.

So alongside Lucentis we now have the biosimilars Ongavia, Byooviz and Ximluci, with others in the pipeline. Biosimilars for Eylea are starting to become available as well and we now have Yesafili, a biosimilar to Eylea. You would not be switched to a biosimilar drug without your consent.

Stem cell therapy

This type of treatment for wet and dry AMD is still in early phase clinical trials. The two patients with wet AMD who were treated at Moorfields Eye Hospital in London in 2015 regained some vision and there have been no issues with safety. Work is ongoing and more patients are being recruited to the trial now.

In the USA there are two clinical trials underway for dry AMD which are showing promising early results. A trial of the treatment called Opregen has shown a few of those treated have regained some vision.

Gene therapy

This form of treatment is very new and uses genes to treat diseases. A harmless virus injected into the macula is able to carry a gene into the cells. The gene provides the code for making a drug, like Lucentis or Eylea. This enables the creation of a ‘drug factory’, as the eye can use the gene to make the drug itself, taking away the need for injections.

There are early phase clinical trials underway using gene therapy for wet AMD in the UK.

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