Bayer continues to pursue therapies and support programs to reduce the burden of treatment and improve outcomes for ophthalmology patients around the world.
Global clinical trials are just part of a comprehensive effort by the German multinational pharmaceutical and life sciences company. Other initiatives include partnerships to address barriers to treatment compliance, awards programs acknowledging innovative research, and approximately 20 studies evaluating the use of Eylea (aflibercept) in the real world.
Dr Patrick Bussfeld who has been VP, Head of Medical Affairs Therapeutic Area Ophthalmology, at Bayer since 2016, says Bayer’s commitment to ophthalmology is driven by the one billion people worldwide who suffer from vision impairment that could have been prevented.
“It’s clear that this is an area of significant unmet need… It’s this reality that motivates Bayer’s continued investment in ophthalmology research and commitment to improving outcomes for ophthalmology patients around the world.”
Having spent 10 years in clinical practice prior to joining Bayer, Dr Bussfeld has a deep understanding of patient needs. Following his medical studies in Germany and the UK, he commenced his medical career at the University of Bonn before taking up positions in research and within clinics at the Universities Munich and Dusseldorf. He obtained his board certification in neurology and restorative neurology in 2007 and joined Bayer in 2008 as the Medical Advisor in Neurology. Since then he has held several positions in medical affairs with the company.
Dr Bussfeld believes that along with providing vital ophthalmology therapies, Bayer’s most significant achievement in the eye health field to date has been to support the wider community in its effort to prevent avoidable vision loss.
“Our approach has seen us engage key stakeholders in the ophthalmology community, who help us identify and understand the main barriers to providing optimal ophthalmic care around the world. We’ve then collaborated with these stakeholders to establish initiatives to address local barriers.
“For example, Bayer sponsors the Vision Academy, an active community of more than 80 experts worldwide, who provide guidance for best clinical practice in the management of retinal disease.”
Members of the Vision Academy include Australia’s Dr Jennifer Arnold (Marsden Eye Specialists), Dr Andrew Chang (Sydney Retina Clinic and Day Surgery), A/Prof Alex Hunyor (University of Sydney), Dr Anthony Kwan (Queensland Eye Institute), Dr Lyndell L. Lim (University of Melbourne, Royal Victorian Eye and Ear Hospital), and Prof Paul Mitchell (University of Sydney/ Westmead Millennium Institute, Sydney West Local Health Network).
Since 2016, Bayer has also supported the Diabetic Retinopathy (DR) Barometer, an action network of individuals and organisations working to improve the vision health outcomes of adults with diabetes.
Led by the International Federation on Ageing (IFA), the International Agency for the Prevention of Blindness (IAPB), the International Diabetes Federation (IDF), the Vision Academy, and supported by Bayer, this program seeks to gain insights into vision loss caused by diabetes and identify barriers to the effective management of DR. Information on diabetes has been gathered from across the globe, including in Australia.
Another example of Bayer’s commitment to ophthalmology outcomes is its Global Ophthalmology Awards Program (GOAP), which supports innovative research in retinal disease globally. The program has awarded over AU$6 million in research and training grants worldwide since its establishment in 2012. Among the winners are multiple Australian researchers, including Associate Professor Matthew Patrick Simunovic (Save Sight Institute, University of Sydney) and Dr Mali Okada (University of Melbourne) in 2019 and Associate Professor Gerald Liew (South West Retina, Sydney) in 2018. An Australian is among the 2020 winners who were yet to be announced at the time of going to print.
AFLIBERCEPT RESEARCH CONTINUES
Clinicians in Australia recently welcomed the listing of a new pre-filled syringe to administer Bayer’s aflibercept, on the Pharmaceutical Benefits Scheme (PBS) for treatment of four retinal conditions at a subsidised rate.
The new pre-filled syringe provides clinicians with a more convenient option to treat neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME), retinal vein occlusion (RVO) and subfoveal choroidal neovascularisation (CNV).
Extending the treatment intervals to reduce the burden of treatment is the next focus of effort. PHOTON and PULSAR trials of a new aflibercept formulation for intravitreal injection in adults with visual impairment due to DME and nAMD, are due for completion in 2023.
“Our preclinical evaluation prior to study initiation indicated that a four-fold increase of the dose may be sufficient to extend the durability of aflibercept,” explained Dr Bussfeld. “Should the trial prove successful, this may allow eligible patients to benefit from an injection frequency as low as three to four times per year. It should be noted that such intervals are already achievable for some patients with aflibercept 2mg, with this trial aiming to extend that eligibility to further patients.
“We are also assessing safety risks compared to the 2mg dose, and will be assessing the benefit-risk ratio of the new aflibercept formulation in studies.”
Bayer is currently targeting 12- and 16-week intervals in the first year of treatment, the results of which will inform intervals moving into the second treatment year. A final assessment of the durability advantage will be possible once the data and benefit-risk ratios from the studies are fully evaluated.
This potential to further reduce the treatment burden of anti-VEGF therapy, as well as Bayer’s research into supporting vision outcomes in other patient populations, is something that is particularly exciting for Dr Bussfeld. So too are the insights coming from a real-world evidence study program involving around 24,000 patients in more than 20 countries, including Australia. Patients enrolled and enrolling live with nAMD, DME or RVO.
“Our ongoing real word evidence study program is helping us to understand the impact of visual impairment and treatment beyond the controlled trial setting, aiding the optimisation and customisation of treatment plans for patients.
“These important insights will help improve clinical practice, guide treatment protocols and facilitate a better understanding of the patient population,” Dr Bussfeld said.
Bayer is also researching the use of aflibercept for the treatment of patients with Retinopathy of Prematurity (ROP) – one of the most common preventable causes of blindness in children, causing irreversible visual impairment in over 32,000 infants worldwide each year.
Finally, in addition to studying established therapies, the company is embracing new areas of research, such as finding a treatment for onchocerciasis, also known as River Blindness, a vector borne infectious disease. Onchocerciasis threatens more than 205 million people living in sub-equatorial areas around the globe, leaving more than 1.15 million people with severe visual complications.