Novartis launches FocalView app, providing opportunity for patients to participate in ophthalmology clinical trials from home

• - FocalView is a first-of-its-kind app designed to modernize ophthalmic clinical trials, making them more accessible and flexible
• - Using patients' self-recorded measurements, FocalView aims to enable more sensitive trial endpoints and more accurate patient-reported outcomes
• - Using the Apple ResearchKit platform, Novartis is making FocalView vision tests freely available to the scientific community

EAST HANOVER, N.J., April 25, 2018 /PRNewswire/ -- Novartis announced the launch of its FocalView app, an ophthalmic digital research platform created with ResearchKit. FocalView aims to allow researchers to track disease progression by collecting real-time, self-reported data directly from consenting patients. By adapting the design of clinical trials to suit the daily routine of patients, the app may reduce barriers to participation, leading to a more nuanced understanding of ophthalmic diseases and potentially accelerating the development of novel treatments.

Data capture in traditional ophthalmic clinical trials can be inflexible and infrequent, making it difficult for researchers to monitor patients' disease activity and capture real-world patient experiences. FocalView aims to help patients complete various assessments, gaining feedback on their visual function, including any changes over time. At the same time, the app could provide researchers with a greater volume of real-world, patient-reported data, creating more flexible and accessible clinical trial designs.

"Because patients with eye diseases are often not as mobile, FocalView has the potential to offer tremendous benefit for the ophthalmic community and for researchers looking to develop better treatments for these patients," said Dr. Mark Bullimore, Medical Advisor for the creation of FocalView and Dean of the Southern California College of Optometry, Marshall B. Ketchum University. "Collating validated patient-reported outcomes in clinical trial research is no longer a nice-to-have. This kind of data is fast becoming a critical element of research and development, because it offers a better reflection of real-world patient experiences, fosters better patient compliance and provides researchers with richer and more accurate data points."

FocalView will be tested in a prospective, non-interventional study to evaluate the app's efficacy and usability in assessing visual function. These measurements include visual acuity and contrast sensitivity. Researchers will in turn assess ease of use, level of enrollment and the ability to obtain important documentation for future clinical trial research, such as informed consent. In the next phase, the app will be validated against traditional visual testing that takes place within conventional clinical settings.

"Optimizing digital technology in research and development, particularly in ophthalmic disease, could have a marked impact on the quality of the data we capture," said Bertrand Bodson, Novartis Chief Digital Officer. "We believe apps like FocalView, which we've made freely available to the research community on an open-source platform, can help accelerate the development of treatments and bring them to the patients who need them most."

FocalView is now available for download from the App Store in the U.S. Consent to contribute to research data will be required before a user can interact with the tool. Novartis is planning to launch in additional markets in the future.

About Novartis in ophthalmology
Novartis is a leading ophthalmology company, with therapies that treat both front and back of the eye disorders, including retina diseases, glaucoma, dry eye and other external eye diseases. In 2016, approximately 200 million patients worldwide were treated with Novartis ophthalmic products.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding the potential efficacy and usability of the FocalView app, or regarding the potential of the FocalView app to allow Novartis to gain a more nuanced understanding of ophthalmic diseases and to potentially accelerate the development of investigational treatments, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the FocalView app will be determined to be effective and useable for assessing visual function in the planned prospective, non-interventional study, or in any other study, or at any particular time. Neither can there be any guarantee that the FocalView app will enable more sensitive trial endpoints and more accurate patient-reported outcomes. Nor can there be any guarantee that the FocalView app will accelerate the development of investigational treatments or that the FocalView app and such products will be commercially successful in the future. In particular, our expectations regarding the FocalView app and such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; potential or actual data security and data privacy breaches, or disruptions of our information technology systems; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com (link is external).

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