Ora’s Ethos

Sally Tucker and David Bingaman speak about Ora’s involvement in ophthalmic therapeutic development, which spans from preclinical research to clinical trials. The discussion covers exciting new steps for the company, AI’s influence, and the importance of patient advocacy.

What is exciting about Ora and ESCR?
 

David Bingaman: There is a lot going on in topical delivery at the moment, including topical applications of drugs to the front of the eye. Many of our medical device companies are on their way to a CE mark so, as that goal approaches, we are contemplating how to bring those devices to the US and how to navigate that transition with approval from the FDA.

What kind of drug delivery systems are you looking to create?
 

DB: There are many different types of devices; some are implanted into the anterior chamber, some right behind the iris, and some materials used for glaucoma filtration are placed in the superciliary space. The posterior space also has a variety of device technologies. Now that anti-VEGF therapies have proven successful, the next step is to establish long-term delivery – the less invasive, the better.

What challenges do you expect to encounter?
 

Sally Tucker: It’s important that we have regular interactions with the FDA to understand the regulatory approvals required for the products. We also need to maintain strong relationships with investigators across the US and Europe and ensure that they have the capabilities to support any clinical trials that need to be done. We are aware that time is money, so we are conscious of bringing products to market in the most time-efficient manner possible.

What are the next steps?
 

ST: We have offices in the US, Ireland, China, Japan, Australia, and mainland Europe. We have to ask how we can support companies from a global perspective. It’s important to have globalized regulatory support that we can provide according to the commercial strategy the company wants to follow. Because we work with clinicians, researchers, and scientists who are experts in ophthalmology, we believe that it is important to meet the needs of individual sites and patients. The final thing to touch upon is our patient advocacy activities. It is critical that we continually interact with patients so that we understand their conditions and experiences from their perspectives. We need to make sure patients don’t feel like cogs in the machine; without them, we don’t have a trial.

DB: Our R&D group has been working on visual function tests that are specifically targeted toward intermediate AMD, early AMD, nonproliferative diabetic retinopathy, and diabetic macular ischemia. These indications don’t have a proven regulatory pathway, so need new endpoints and tools to advance assets through the developmental journey. In addition, we are combining AI-based image assessment with visual function tests to create a structure-function relationship – helping to define the pathophysiology of these diseases.

What can ophthalmologists do to help with patient advocacy?
 

ST: I think it’s about working with ophthalmologists across the globe to make sure we address their individual needs. We are very keen to get patient feedback after clinical trials and use that feedback to support and improve sites. The investigators are great at questioning eligibility criteria so that trials don’t become too arduous for patients.

DB: Our chief medical officer, Gustavo Dimauro, directly engages with patients and is therefore conscious of the tension between obtaining data and maintaining empathy for the patient.

Will AI help with patient advocacy?
 

DB: We have a new technology called the EyeCup™ which came out of our R&D company. It couples a smartphone with a data software package in a plastic cone that can be fitted onto the orbit to take images of the interior. These images are then assessed by AI. For either posterior or anterior segment, AI can help determine which patients are best for a given trial.

ST: We can also improve patient advocacy by allowing patients to complete some of the assessments from their homes.

Can you comment on the importance of raising awareness on global research?
 

ST: I had a patient with diabetes reach out to me. She was a very active patient advocate who worked in a number of universities and healthcare settings. She commented on the lack of research in diabetic eye disease, which shocked me, because there is a huge amount of research in this area. This interaction highlighted the fact that even experienced patients aren’t necessarily aware of ongoing research. It is important to make this research accessible – and it’s important that we do it in an empathetic way.

DB: Our own website, Ora connects, provides information on ongoing clinical research. If a patient expresses interest on the website, they are contacted about ongoing trials and asked whether they are interested in participating or have opinions they want to share.

What is the best way to raise awareness in patients?
 

ST: We need to work with not only ophthalmologists, but also other health care professionals. There are ways of leveraging primary care to support the identification and prescreening of patients, meaning that those practitioners can help support ophthalmologists and enhance patient recruitment without a significant additional burden.

DB: In the US, optometrists can participate directly in clinical trials. Therefore, we work with both ophthalmologists and optometrists to bring patients in for appointments. We also have a recruitment office that partners with our marketing team to get the word out and engage the community for specific trials.

ST: We are passionate and committed to the field of ophthalmology, to the sites, and to our patients. I think that we’re in a really exciting time with the development of so many new technologies – and AI’s clinical support capabilities are testament to that.