Theranostics
(therapy guided by imaging diagnostics) is a combination of therapy and diagnostics; it is a revolutionary paradigm of personalized, predictive and precision medicine, which makes use of light activated image-guided drug therapy to achieve the best outcome in the treatment of visual disorders.
Regensight has developed a theranostic platform to treat demanding visual disorders in young people, such as myopia and keratoconus, and in the elderly, such as presbyopia.
Out platform enables surgeons in precisely tailoring the therapeutic UV-A light energy dose based on patterned riboflavin concentration in the cornea. We set a new, incision-free, standard in vision care.
THERANOSTICS is a precise, predictive therapy guided by real time assessment of treatment response.
The platform is the world’s first eye-care device using the IoMT (Internet of Medical Things) technology providing remote control for predictive maintenance, improving clinical research data collection and product improvement.
The Platform holds “fleet’s learning” ability, thus making Regensight as the world’s first biomedical manufacturer of an adaptive surgical platform.
Our Short-Term Plan is focused on introducing theranostics for developing new treatment options for improving vision in keratoconus patients.
Our Mid-Term Plan is focused on developing revolutionary treatment options for people with low-grade myopia and presbyopia.
Our approved products
Currently, Regensight manufactures three CE marked medical devices for the indication of use of treating keratoconus and corneal disorders with theranostic-guided corneal cross-linking procedures. Learn More
Current surgical treatments of myopia, such as laser correction, although effective, have known problems like pain and the risk of infection and corneal scarring. In addition, laser correction is contraindicated in at least one third of myopes, because the cornea is thin or has keratoconus.
Until today there is no effective and safe surgical solution for the most frequent visual disorder in the elderly, such as presbyopia.
Corneal cross-linking with riboflavin and UV-A light could be effective in halting keratoconus progression only if the corneal epithelium is removed; however, the epithelium removal has 15% rate of complications and the procedure does not improve visual acuity, which remains low due to the corneal distortion.
Current limits of riboflavin/UV-A corneal cross-linking
Efficacy of corneal cross-linking, intended as stabilization of disease progression, is highly variable (from 10% to 90%) using the standard protocol (i.e., the cornea is de-epithelialized). This variability forces eye surgeons to prefer the standard protocol, which, however, has high complication rates (incidence: 15%).
UV-A medical devices without theranostics have several technical limits:
- Do not provide information on the concentration and UV-A photo-activation of riboflavin into the cornea, which is the main parameter determining treatment efficacy;
- Do not assess treatment efficacy, causing a delay in the assessment of disease progression and inadequate patient care;
- Do not provide a full range of treatment operations to the surgeon;
- Do not maintain maximum device realiability during operation.
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Roszkowska AM et al. A randomized clinical trial assessing theranostic-guided corneal cross-linking for treating keratoconus: the ARGO Protocol.
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Lombardo G, Bernava GM, Serrao S, Lombardo M. Theranostic-guided corneal cross linking: pre-clinical evidence on a new treatment paradigm for keratoconus.
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Lombardo G et al. Non-invasive optical method for real-time assessment of intracorneal riboflavin concentration and efficacy of corneal cross-linking.
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Lombardo M, Lombardo G. Non-invasive and real time assessment of riboflavin consumption in standard and accelerated corneal cross-linking.
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Lombardo G et al. Comparison between standard and transepithelial corneal cross-linking using a theranostic UV-A device.
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Lombardo M, Lombardo G.
Grand Round Stanford
Lombardo M, Lombardo G.
Grand Round UCL
