PK-EYE OVERVIEW
PK-EYE OVERVIEW
ABOUT US
Optceutics Ltd. uses the PK-Eye™ model, a dynamic ophthalmic pharmacokinetic model, to speed and enhance the development of ocular formulations.
The PK-Eye™ can be used to:
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Identify the right formulation technology
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Optimise the selection of dose and dose frequency
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Compare activity and duration to known products
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Reduce program risk BEFORE moving into costly animal and human studies
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Speed the development of biosimilar products
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Generate unique data to support additional patent coverage
Optceutics Ltd’s business model allows:
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Fee-for-service research and strategic collaborations
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Preclinical ophthalmic formulation optimisation
need for
BetteR
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retinal therapy
Blinding diseases are an increasing burden to our ageing population. The recent introduction of intraocular biological based medicines, such as antibodies, has revolutionised the treatment of posterior segment diseases e.g. wet age-related macular degeneration (AMD), which is the main cause of blindness in the elderly. Biological therapies will continue to revolutionise retinal therapy.
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Development of new therapies can be accelerated using the PK-Eye™ model to augment traditional preclinical studies to minimise the risks of clinical studies. Optceutics Ltd provides rapid and cost-effective optimisation of retinal drugs and formulations. The PK-Eye™ platform addresses many of the issues facing intraocular drug development by overcoming limitations of established preclinical models.
of ophthalmic therapies fail early stage clinical studies.
60%
FAILURE
Biological
mismatch
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Developing long-acting biological-based drugs designed for human use is not possible in animals because the animals quickly clear the drug by the formation of anti-drug antibodies (ADAs). Also, animal models do not mimic the ageing human vitreous, anatomy and aqueous flow rate, further limiting clinical translation.
lack of standard intraocular model
The pharmaceutical development of medicines (e.g. orally administered tablets and inhaled dry powder drugs) all rely on the extensive use of in vitro models to optimise performance. Until the development of the PK-Eye™, no model existed for the development of intraocular drugs.
We have developed a compartmentalised in vitro model of the human eye called the PK-Eye™ to accelerate the development of longer acting intraocular medicines. The PK-Eye™ makes it more feasible to determine intraocular clearance times, dose escalation profiles, pharmacokinetic effects and stability profiles that are all needed for intraocular drug development.
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It significantly reduces and replaces animal use during preclinical development of ocular medicines fulfilling the 3Rs (reduction, refinement and replacement) framework. The PK-Eye™ enables more confident decision-making to increase the chances for the successful clinical translation of intraocular therapies.
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The new generation PK-Eye™ has automation features to allow real-time 24x7 monitoring to faciliate the development of products/IP for intraocular formulations that would by other means be expensive and time-consuming.
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