PK-EYE OVERVIEW
PK-EYE OVERVIEW
ABOUT US
Optceutics has developed the PK-Eye™, an automated high throughput ophthalmic pharmacokinetic model, designed to speed and enhance development of intra-ocular drugs and formulations.
The PK-Eye™ can be used to:
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Identify and develop optimal intra-ocular formulation technology
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Facilitate selection of dose and dose frequency
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Compare activity and duration to existing marketed products
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Reduce program risk BEFORE moving into costly animal and human studies
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Streamline development and regulatory process for biosimilar and biobetter products
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Generate unique data to support additional patent coverage
With a laboratory located in the former Pfizer UK research hub in Discovery Park, Optceutics works with ophthalmic drug developers worldwide through fee-for-service and risk shared strategic collaboration. Please contact us to discuss how Optceutics could support your ophthalmic drug programme.
need for
BetteR
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retinal therapy
Blinding diseases are an increasing burden to our ageing population. The 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.
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​Optceutics' PK-Eye™ can be used to augment preclinical studies to reduce the risk of clinical failure. Rapid and cost-effective, the PK-Eye™ facilitates optimisation of intraocular drugs and formulations; avoiding 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). Animal models are also limited by their significant differences from human anatomy and intra-ocular fluid flow, as well as an inability to mimic the human ageing eye.
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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