Dedicated app measures outcomes of presbyopia eye drops

The app, currently used within the UNR844 clinical trials, may become a useful companion for patients at home.

An app that is closely related to the development of UNR844 presbyopia-correcting ophthalmic solution from Novartis effectively measures vision changes at home, monitoring the effects and potentially warning the patient when it is time to repeat the treatment.

“Within our clinical studies, vision is measured in the clinic with the traditional tests, then with the app, and then the app is used at home. One of our goals is to verify if results are the same. This is a validation test, which is key to our study design for UNR844,” Mark Wuttke, global program head of the UNR844 program in the ophthalmology development unit at Novartis, told Ocular Surgery News.

According to his colleague Stephane Wolf, head of digital solutions, ophthalmology, it is a good way to monitor vision over time and find out when patients may need to be re-treated.

“What we decided to do is take the vision test which is performed in the clinic and make it portable. People can do it directly from the comfort of their home. All they need to have is a smartphone,” he said.

 

David Writa

Measuring progress

The app has been used so far within the UNR844 clinical trials, which are currently ongoing and still recruiting at 15 sites across the United States. A dose-finding trial is planned for next year in a global territory.

David Wirta, MD, one of the U.S. trial investigators, said that the treatment is showing potential efficacy and is well tolerated.

“The drops work by reversing some of the age-related changes in the lens. They are delivered to the ocular surface, penetrate into the eye and convert to the supplement that reverses the aging processes. The lens becomes more flexible, and this has shown to help presbyopia,” he said.

The app is a way for measuring progress at home, thus reducing the number of visits to the clinic. It allows for closer, more consistent monitoring. Within the study, patients consent to have the data collected and processed by Novartis for the purposes of validation. Once available for more general use, Novartis will not collect patient data except when agreed to by the patients for specific studies or purposes.

“Currently the app is used for study purposes, but in the future it could drive new prescriptions and refills. It could help the patient understand when it is time to see the physician again to reassess vision and restart treatment. It can also help physicians to see how consistent patients have been with the drops. It can encourage compliance, relying on a means like the smartphone, which patients use a lot and carry with them all the time,” Wirta said.

 

Fast and precise

The test provided by the app is a Landolt C test, asking the patient to touch the spot on the screen where the opening of the C is oriented. The C patterns become progressively smaller until the threshold between seeing and not seeing the opening of the C is detected, and there the patient is challenged and vision is measured.

“We improved the test and made it faster. It takes now less than 1 minute to figure out what’s the limit of your vision,” Wuttke said.

Unlike other vision tests available on smartphones, it will be assessed and validated by regulators to ensure that it provides the highest level of accuracy.

“Whenever the distance between the phone and your face varies, if you cheat by bringing it closer, it stops immediately and asks you to reposition the screen back to the right distance,” Wolf said.

 

A lifestyle drug

Presbyopia affects well more than a billion people globally. UNR844 has the potential to modify age-related changes by using drops that contain a combination of lipoic acid and choline, which are two naturally occurring substances. These drops reverse some of the aging processes that cause the lens to become less flexible and less able to focus on near vision.

“I think there will be a large subset of presbyopic people using this drug. The main thing is that it is a lifestyle drug. There are many people now who actively look after their health, who take supplements, exercise, eat well, and there are others who let things happen, don’t work out, don’t go to see a doctor, don’t take medications regularly; they just want a quick fix,” Wirta said. “This drug is not for the quick-fix people. It is for the people who care for themselves, who are health conscious, who want to be proactive. For those people, it will be great.” – by Michela Cimberle

 

For more information:

David Wirta, MD, can be reached at David Wirta, MD & Associates, 520 Superior Ave, Suite 235, Newport Beach, CA 92663; email: david.wirta@drwirta.com.

Stephane Wolf and Mark Wuttke can be reached at email: media.relations@novartis.com.

 

Disclosures: Wirta reports he receives grant support from Novartis and is a paid investigator for the study. Wolf reports he is the head of digital solutions, ophthalmology, at Novartis. Wuttke reports he is the global program head of the UNR844 program in the ophthalmology development unit at Novartis.

 

An app that is closely related to the development of UNR844 presbyopia-correcting ophthalmic solution from Novartis effectively measures vision changes at home, monitoring the effects and potentially warning the patient when it is time to repeat the treatment.

“Within our clinical studies, vision is measured in the clinic with the traditional tests, then with the app, and then the app is used at home. One of our goals is to verify if results are the same. This is a validation test, which is key to our study design for UNR844,” Mark Wuttke, global program head of the UNR844 program in the ophthalmology development unit at Novartis, told Ocular Surgery News.

According to his colleague Stephane Wolf, head of digital solutions, ophthalmology, it is a good way to monitor vision over time and find out when patients may need to be re-treated.

“What we decided to do is take the vision test which is performed in the clinic and make it portable. People can do it directly from the comfort of their home. All they need to have is a smartphone,” he said.

 

David Writa

Measuring progress

The app has been used so far within the UNR844 clinical trials, which are currently ongoing and still recruiting at 15 sites across the United States. A dose-finding trial is planned for next year in a global territory.

David Wirta, MD, one of the U.S. trial investigators, said that the treatment is showing potential efficacy and is well tolerated.

“The drops work by reversing some of the age-related changes in the lens. They are delivered to the ocular surface, penetrate into the eye and convert to the supplement that reverses the aging processes. The lens becomes more flexible, and this has shown to help presbyopia,” he said.

The app is a way for measuring progress at home, thus reducing the number of visits to the clinic. It allows for closer, more consistent monitoring. Within the study, patients consent to have the data collected and processed by Novartis for the purposes of validation. Once available for more general use, Novartis will not collect patient data except when agreed to by the patients for specific studies or purposes.

“Currently the app is used for study purposes, but in the future it could drive new prescriptions and refills. It could help the patient understand when it is time to see the physician again to reassess vision and restart treatment. It can also help physicians to see how consistent patients have been with the drops. It can encourage compliance, relying on a means like the smartphone, which patients use a lot and carry with them all the time,” Wirta said.

 

Fast and precise

The test provided by the app is a Landolt C test, asking the patient to touch the spot on the screen where the opening of the C is oriented. The C patterns become progressively smaller until the threshold between seeing and not seeing the opening of the C is detected, and there the patient is challenged and vision is measured.

“We improved the test and made it faster. It takes now less than 1 minute to figure out what’s the limit of your vision,” Wuttke said.

Unlike other vision tests available on smartphones, it will be assessed and validated by regulators to ensure that it provides the highest level of accuracy.

“Whenever the distance between the phone and your face varies, if you cheat by bringing it closer, it stops immediately and asks you to reposition the screen back to the right distance,” Wolf said.

 

A lifestyle drug

Presbyopia affects well more than a billion people globally. UNR844 has the potential to modify age-related changes by using drops that contain a combination of lipoic acid and choline, which are two naturally occurring substances. These drops reverse some of the aging processes that cause the lens to become less flexible and less able to focus on near vision.

“I think there will be a large subset of presbyopic people using this drug. The main thing is that it is a lifestyle drug. There are many people now who actively look after their health, who take supplements, exercise, eat well, and there are others who let things happen, don’t work out, don’t go to see a doctor, don’t take medications regularly; they just want a quick fix,” Wirta said. “This drug is not for the quick-fix people. It is for the people who care for themselves, who are health conscious, who want to be proactive. For those people, it will be great.” – by Michela Cimberle

 

For more information:

David Wirta, MD, can be reached at David Wirta, MD & Associates, 520 Superior Ave, Suite 235, Newport Beach, CA 92663; email: david.wirta@drwirta.com.

Stephane Wolf and Mark Wuttke can be reached at email: media.relations@novartis.com.

 

Disclosures: Wirta reports he receives grant support from Novartis and is a paid investigator for the study. Wolf reports he is the head of digital solutions, ophthalmology, at Novartis. Wuttke reports he is the global program head of the UNR844 program in the ophthalmology development unit at Novartis.

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