Roche Farma is focused on the investigation of the main causes of blindness, among which are age-related macular degeneration (AMD), diabetic macular edema and other retinal diseases. The company is committed to personalized research, in which the risk factors for the disease and the severity and progression of these pathologies can be identified through genetic analysis.
The medical director of Roche Farma España, Dr. Beatriz Pérez Sanz comments on the main advances that the company is developing through innovative treatments for people living with these diseases.
Question. How are you coping with the pandemic at Roche and how has your activity been affected?
Answer. Our priority has always been patients and research, which is the main tool we have for these people to receive the best treatments. Despite the pandemic, we have moved on, having to redirect some of the projects underway during the toughest moments of the crisis. However, we have continued recruiting and monitoring, many times remotely, to continue the studies that were already underway.
Research is and will continue to be our priority at all times, as well as being closer to our stakeholders and becoming a true scientific ally of the health system. The company has started a transformation process more oriented towards science, capable of giving a greater and better response to health challenges in an increasingly changing environment, while maintaining our firm commitment to research and innovation. biomedical.
The objective is to collaborate with the health system and its professionals to provide patients with the best possible approach to their disease, in line with the changes that scientific and technological evolution are producing in the health environment. To achieve this, since this month of January we have begun to operate with a completely different organizational model, more agile, flexible, close and horizontal, less hierarchical, which places science at the center of all our actions as a company.
P. Specifically, in the area of Ophthalmology, how is this new approach being implemented?
R. We want to make a real difference for people with vision loss and their caregivers, building on our legacy of pioneering innovative therapies for those in need. Innovation, personalized medicine, molecular engineering and biomarkers are the tools we use to design the right treatments for the right patients.
We are developing innovative ophthalmic treatments for people with vision loss such as Faricimab and the Port Delivery System (PDS) with ranibizumab.
Faricimab is the first bispecific antibody designed for ophthalmological use, which targets two pathways involved in various retinal diseases. A therapy designed to promote vascular stability, which can achieve better vision results for longer.
The PDS is a permanent, rechargeable ocular implant that continuously delivers a tailored formulation of ranibizumab over a period of months, potentially reducing the burden associated with treatment with frequent ocular injections.
Q. What research programs are you carrying out in Ophthalmology?
R. We have the broadest portfolio for retinal diseases in the area of Ophthalmology, which includes studies in early and late stages of development. Our pioneering clinical programs focus on some of the leading causes of blindness and visual impairment worldwide, where there are many unmet needs.
At a late stage we are investigating the two potential treatments, mentioned above, to evaluate the different problems of the retina, including AMD, DME and diabetic retinopathy, including VOR. For early stages, our program includes gene therapies and treatments for geographic atrophy and other diseases that affect vision, including rare and inherited diseases.
Q. In what phase are these studies?
R. We currently have several phase III studies with faricimab and PDS, with a high participation of Spanish centers and a high number of patients benefiting from this new therapy, for DME, DMAEn and RVO; three phase II studies for diabetic retinopathy and for geographic atrophy and three other phase I investigational molecules.
Faricimab represents the first new class of drugs in nearly a decade for patients with DME and AMD. Phase III results show that this therapy has the potential to provide longer vision improvement for these individuals, while reducing the burden associated with treatment with frequent use of intravitreal injections. Therefore, they have recently been presented to regulatory authorities around the world, with the aim of making this new therapeutic option available to patients as soon as possible. Something that in the case of EMD would be a great milestone, considering that in our country it is the leading cause of blindness in working-age adults.
Q. How do you work to improve the quality of life of these patients?
R. Retinal diseases can be difficult to treat, considering that the way they develop and progress varies from person to person. Currently, more than two million people around the world live with a visual impairment, and of these, at least 1 billion have a visual impairment that could have been prevented or has not yet been solved.
Our approach is focused on taking advantage of our deep knowledge of the biology of the underlying disease and combining it with new real-life data, through machine learning and advanced algorithms. This approach allows us to design and evaluate therapies that target new pathways, as we are already doing with faricimab, that work differently or are administered through long-acting mechanisms. This places us in an ideal position to offer highly personalized and effective solutions to improve the quality of vision and quality of life for these people.
Q. Your research is very focused on personalized medicine and artificial intelligence, what benefits does it bring?
R. We work in a comprehensive and personalized approach to patients, based on the most advanced technology that helps us collect and analyze clinical data to further refine the diagnosis. The use of Artificial Intelligence (AI) and genetic information helps us to improve detection and prevention, in order to identify earlier the people with the highest risk of suffering vision loss and to offer useful information on the most appropriate treatment for each case.
Q. How important is Ophthalmology in Roche’s research?
R. Under the principles of integrity and excellence, from Roche we have contributed to change the course of diseases as complex as cancer. We are pioneers both in the development of personalized treatments and diagnostic tools and tests, essential to select the patients who will respond to these drugs. And in this same line we are working in the area of Ophthalmology, being aware that we have to seek answers to unmet needs, such as reducing the burden associated with treatment, developing new routes of administration with prolonged action, identifying new mechanisms action, and offer more effective and safer therapies.
We are leaders in Innovation and Investment in R&D, investing about 20% of our annual income in R&D. Specifically, in the area of Ophthalmology, last year we dedicated 9.8 billion dollars to the search for new and innovative tools that help reduce the devastating impact of these diseases.