Case Study
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The company's focus on bringing personalized health solutions extends into ophthalmology, where longer-acting therapies are critical to provide a better quality of life for patients, such as those with AMD, diabetic eye disease and other diseases of the retina.
More than 300 million people worldwide have retinal diseases, yet ophthalmology is a major area of unmet healthcare needs, with a significant burden of disease and large untreated populations. Longer-acting therapies will reduce treatment burden but will not reduce the need to monitor disease. Because patients are at risk of irreversible loss of vision, a physician's desire to monitor may lead to persistent clinic visits, even with success of longer-acting therapies. However, frequent clinic visits are not always a feasible option for patients.
The World Health Organization found that around the world, more than 2 billion people have some type of vision impairment. Nearly half of those people could have avoided vision loss with intervention, or have not yet addressed it. And the numbers are poised to rise: The risk of vision loss increases as a person ages and AMD is the most common cause of blindness and vision loss in people over 65. The number of Americans in this age group is estimated to grow from 48 million to 88 million by 2050. Yet as the patient demand continues to grow, existing providers are already at capacity, making it likelier than ever before that many patients won’t be able to receive the regular screening they need.
Even among those who can access care, it’s easy to lose track of an annual retinal screening—especially for people managing complex chronic diseases like diabetes who are tracking many symptoms and risks. Furthermore, annual exams only provide a snapshot of the patient’s eye health at that moment in time. Continuous monitoring of changes in vision with alerts to HCPs can help get patients on treatment sooner, potentially slowing down or reducing vision loss.
These are just a few of the many challenges patients face in their AMD and DR journeys.
The problem
Changes in vision can occur rapidly, and untreated symptoms can lead to permanent vision loss. But frequent clinic visits can be a burden to patients for many reasons.
The solution
With an emphasis on the value of clinical validation, Roche launched myVisionTrack as a Software as a Medical Device (SaMD) to help patients easily track and report their visions changes remotely between visits. Roche selected BrightInsight, with deep experience creating and registering SaMDs, to help bring myVisionTrack to life.
Retinal diseases are treatable, but to do so we need to catch deterioration as it occurs and leverage the narrow window of opportunity [to intervene and] slow down or potentially even reverse vision loss. This is nearly impossible when check-ups [...] are spaced many months apart and are often dropped altogether for various reasons.
Leslie Anne Fendt, PhD
Global Program Lead, Remote Vision Monitoring, Roche
Roche is committed to creating remote vision monitoring experiences for patients to test their own vision at home, between appointments. Roche engaged BrightInsight to build myVisionTrack and successfully register it an SaMD with the FDA. BrightInsight also served as the Legal Manufacturer of Record (LMR).
The app helps clinicians optimize the usage of Roche’s portfolio of therapies that inhibit disease progression, which are usually delivered as monthly or bi-annual injections. The frequency of injections depends on the degree of retinal deterioration, which requires a retinal exam to assess. Missed or infrequent retinal scans thus limit the ability to increase therapy usage for patients who could greatly benefit.
The solution has two key components:
myVisionTrack app features for patients
Web-based clinician dashboard features:
We are proud to offer myVisionTrack as one of few clinically validated vision tracking apps and thank BrightInsight for helping us achieve this milestone. We chose BrightInsight to deploy our app because of the depth of experience of their team, their compliant platform, and their ability to build and submit the myVisionTrack app to the FDA in a matter of months."
Leslie Anne Fendt, PhD
Global Program Lead, Remote Vision Monitoring, Roche
BrightInsight successfully registered the myVisionTrack app with the FDA in late 2023, the app went live in the app store in early 2024 and currently has patients and clinician offices using the solution in the United States. Roche plans to expand their solutions to include the and EU.
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