The Challenges:

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The standard of care for nAMD is repeated intravitreal injection with anti-VEGFs injections.
Evidence shows that optimal outcomes are achieved with treatment frequency of approximately 8 injections/ year.
However, evidence also show that the average number of injections and treatment visits observed in real- world clinical situations are significantly lower than expected. Contributing factor to this undertreatment is an overwhelmed healthcare system which cause physicians to miss disease activity in 16.6%¹ to 29.6%² of OCT readings compared to Reading Centers.

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Clinical studies are complex, expensive and time consuming.‍

Today the average time to bring a new drug to the market is ten to twelve years³.
The initial phase of R&D, drug discovery, can take five to six years, followed by an additional five to seven years for clinical trials.
To bring a new drug to the market takes an estimated average cost of $2.6 billion.
Key inefficiencies are:‍

- decentralized data in multiple locations
- long time (e.g. 9-10 months) to submit to regulatory approval, which then can take up.

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1. Gunnemann Fet al. (2017)  Influence of OCT-examination during ranibizumab treatment of AMD patients in a real-life setting (Ocean study). Invest. Ophthalmol. Vis. Sci;58:412.

1. Martin DF, Maguire MG, et al. (2012). Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 2012;1388–98.
2. Deloitte. Intelligent Clinical Trials. (2020). https://www2.deloitte.com/content/dam/insights/us/articles/22934_intelligent-clinical-trials/DI_Intelligent-clinical-trials.pdf