An introduction to personalised healthcare for the eye

Sascha Fauser, Global Head of Ophthalmology, Roche Pharma Research and Early Development (pRED), shares his insights on how personalised healthcare (PHC) can bring benefits to people with retinal diseases. An M.D. by training, Sascha has been a professor of ophthalmology with many years’ experience in clinical ophthalmology and vitreoretinal surgery.
Sascha, can you tell us about the current early research and development work that Roche is pursuing in the area of ophthalmology?

Yes, certainly. Our focus in ophthalmology is on the discovery and development of transformational therapies for people with potentially blinding retinal conditions such as neovascular age-related macular degeneration, diabetic retinopathy and diabetic macular edema. These conditions are incredibly common worldwide and may lead to permanent vision loss. This is a great unmet medical need that, if successfully addressed, could bring meaningful benefit to the lives of many people.

You mention unmet medical need. However, aren’t there already effective therapies on the market for these eye conditions?

Indeed, there are clinically effective therapies available. One of them is anti-VEGF treatment for almost two decades. It leads to a resolution of fluid that accumulates in the retina from leaking new blood vessels in the eye. While these molecules have revolutionised treatment for many people with retinal conditions, a significant proportion of them have shown only partial improvement of vision, or none at all. In these complex diseases, it has become clear that targeting only one cytokine, a small protein important in cell signalling, will not address all aspects of disease.

In that sense, there is still a clear need to develop and deliver tailored treatments that are both more efficacious and more durable. We are already making significant strides toward the development of new combination therapies, and in harnessing innovative technologies from new antibody formats to gene therapy. We also believecan help chart the path in further optimising medical care in ophthalmology and we will continue to innovate in this space for the benefit of patients.

That sounds interesting. Why do you think ophthalmology is especially positioned to leverage PHC?

Across Roche, we have a deep interest and investment in PHC which also extends to retinal conditions. When it comes to PHC and ophthalmology, our overarching strategy is to use advanced analytics to gain new insights from imaging, e.g. optical coherence tomography, derived from our vast databases of retinal images. Beyond that, molecular profiles of ocular fluid, as well as clinical and genomic data, enable us to drive PHC in ophthalmology. We can now automatically characterise numerous features in images from the retina. What used to take weeks of manual work can now be done in minutes. It also helps us to precisely quantify the changes and therefore better understand disease processes and treatment success.

Personalised healthcare will continue to advance, and combination therapies with new additional targets and new technologies, such as bispecific antibodies, will make a difference for patients.

With more and more data available, and the ability to link images to clinical and molecular data, this could help us to develop treatments more efficiently in the future.

There’s a lot of buzz around Artificial Intelligence (AI) and Machine Learning (ML) as analytic tools for large datasets. You talked about advanced analytics in ophthalmology, so how do AI and ML factor into this field of research?

As part of Roche’s large ophthalmology PHC Initiative, we are working with AI and ML tools that can sift through massive datasets to predict response to treatment, as well as the risk of disease progression.

In addition, the information yielded by diverse analytic tools significantly enhances our ability to develop treatments and help ophthalmologists deliver a personalized treatment regimen for their patients. I like to think of our PHC approach in ophthalmology as having a two-way street: both in clinical development and clinical decision support. What helps us in pharmaceutical research and discovery can also help ophthalmologists make treatment decisions.

Can you expand on how PHC will help you to develop better therapies?

Our PHC approach means we will have a better understanding of how patients respond to treatment before enrolling them in clinical trials. This means we can implement leaner and more efficient clinical trials that require fewer people. It also means that as we conduct clinical trials, we have a better sense of which treatments work well.

In addition to imaging data, we can also analyse ocular fluid, the aqueous humour, and quantify several hundred proteins in a very small volume of just a few microliters. This molecular characterization allows us to gain insights into the molecular mechanisms underlying diseases, genetic variations, and other biological phenomena, and to predict response to treatment.

Clinical trials often require collaboration. How are you working with external partners to advance your vision for PHC in ophthalmology?

Partnerships and collaborations play a tremendously important role in everything we do in research and development, and this is particularly true in our PHC and ophthalmology work. In order to be able to compile the massive databases of retinal images, ocular fluid and the like, we partner with clinicians who collect these data at the point of care. There is also a need for partnerships with regard to the data science component of PHC. Roche has a strong track record of partnering for PHC, and although we are still in the early stages of recognising the potential of PHC to transform ophthalmology, I believe we at Roche are uniquely positioned to take advantage of all this knowledge. I am also very excited about the potential of our current and future partnerships.

What else excites you about the potential for PHC in ophthalmology?

As both a scientist and an ophthalmologist by training, I am excited by our potential to gain a much deeper understanding of these debilitating retinal conditions. This will allow us to develop more innovative therapies that will be tailored to the individual's needs, potentially providing benefits over and beyond today’s standard of care. This will also empower clinicians with the decision-making tools to match the right treatment at the right time. Our approach to PHC in ophthalmology may also serve as a real-world proof of concept for how advanced analytics can be potentially used to transform healthcare beyond our therapeutic area, and this excites me as well.

This has been a great introduction to your work and the promise of PHC. Is there anything else you would like to add?

Sure! At Roche, we have the opportunity to tackle challenging clinical problems with the resources and expertise to do it in a serious way. Our people are deeply passionate about both following the science and bringing the latest technological innovations to bear in our work. With Roche’s growing number of PHC initiatives in ophthalmology and other therapeutic areas, we have an emerging need for state of the art data science and other highly specialised talent in PHC. Therefore, I encourage anyone interested in this rapidly evolving space to check out

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