Breakthrough in treatment for wet AMD

New ophthalmology treatment improves patient outcomes, reduces costs, and lowers the burden on services

The IRay stereotactic radiotherapy solution has been designed for the treatment of wet AMD

An innovative new treatment is offering a lifeline to sufferers of a condition that causes loss of sight and blindness.

Oraya Therapeutics is in talks with NHS trusts in the UK about rolling out its IRay stereotactic radiotherapy solution for the treatment of wet age-related macular degeneration (wet AMD).

Wet AMD is a disease characterised by abnormal growth of blood vessels in the macula, an oval-shaped, highly-pigmented yellow spot near the centre of the retina of the eye. The condition is responsible for the vast majority of cases of severe loss of vision in developed countries. If left untreated, it can quickly lead to serious sight problems and even blindness.

Over the past 20 years, ophthalmology has become a more-active marketplace within the MedTech sector, with a number of new technologies being released onto the market.

People have known about the impact of radiation therapy for years, but there has been little success coming up with a technology that is accurate enough to treat the part of the eye that causes the problem, but not the surrounding healthy tissue

In terms of wet AMD, for the best part of 30 years, treatment has involved using a laser to locate and destroy the abnormal blood vessels so as to prevent leaking and the associated deterioration of vision. While this procedure offered some hope for patients, the process of targeting the damaged part of the eye also caused damage to healthy areas.

In the early part of the new Millennium, anti-vascular endothelial growth factor (anti-VEGF) medications became available, delivered via injection to the eye to reduce the growth of new blood vessels and the swelling they may cause.

This discovery has revolutionised wet AMD treatment, but comes with its own drawbacks, namely that an average patient will need between six and eight injections every year throughout their lifetime to maintain vision, putting a huge strain on ophthalmic services as well as costing millions of pounds.

To address this, Oraya Therapeutics has taken the concepts of radiotherapy technology, often used in cancer treatment, one step further to create a low-energy technique that in trials has been shown to offer a significant reduction in anti-VEGF injections while achieving equal or better vision outcomes.

Speaking exclusively to BBH this week, Jim Taylor, the company’s president and chief executive, said: “There is a critical need for new treatments for wet AMD, particularly those that can reduce the burden of anti-VEGF injections. The cost of monthly injections, along with the high volume of patients requiring treatment places a strain on healthcare systems and providers. The cost and procedure can also be challenging for patients and caregivers.”

IRay stereotactic radiotherapy solution for the treatment of wet age-related macular degeneration (wet AMD)

The IRay system consists of a low-energy X-ray source that produces a highly-collimated narrow beam designed to affect only the targeted area of lesion, with minimal scatter onto surrounding healthy tissue. A self-contained automated beam positioning system ensures the precise entry of energy into the eye, avoiding critical structures such as the lens and optic nerve. Specialised software also ensures accurate treatment planning and precise beam positioning, while a proprietary eye stabilisation device, working with the beam positioning system, enables precise localisation and tracking of the eye. It is designed to work alongside drug therapies, reducing the amount of damage caused to the eye and helping to maintain vision into the future.

The INTREPID study, a sham-controlled, double-masked trial has evaluated the effectiveness and safety of the intended one-time radiation therapy in conjunction with as-needed anti-VEGF injections for the treatment of wet AMD. The results at the one year endpoint show a reduction in the frequency of injections by 32% for the treated patients compared with the control group. An analysis of the best responders showed that anti-VEGF injections were reduced by 55%. These patients also achieved better vision outcomes than similar patients in the sham arm of the study.

Taylor said: “The simple fact is that no healthcare system can afford to maintain or sustain the number of injections necessary to enhance outcomes. This will only get worse as the baby boomer generation reach the age where wet AMD is a very real risk. This milestone is expected to happen in less than three years, leading to a huge increase in the number of people who are likely to suffer from this condition.

“People have known about the impact of radiation therapy for years, but there has been little success coming up with a technology that is accurate enough to treat the part of the eye that causes the problem, but not the surrounding healthy tissue.

This really does have everything we look for in terms of medical technologies. It improves patient outcomes, it reduces costs, and it lowers the burden on services

“IRay uses a radiation energy source similar to that needed for a dental X-ray and takes just four minutes to deliver. What is particularly exciting is that it is an intended one-time therapy, so patients will not have to keep returning month after month, year after year to repeat the process.

“This really does have everything we look for in terms of medical technologies. It improves patient outcomes, it reduces costs, and it lowers the burden on services. We also believe it will improve patient compliance.”

Last year the private Optegra Guilford and Manchester Eye Hospitals became the first healthcare providers in the UK to offer the treatment. Consultant ophthalmologist, Sajjad Mahmood, said: “Modern anti-VEGF injection treatments have been very successful at preventing loss of vision, but patients are often anxious about having repeated eye injections. With IRay, it is great to be able to offer patients the possibility of maintaining their vision while reducing their need for injections.”

Taylor said it was hoped the treatment would become increasingly available on the NHS over the course of the year.

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