Development
What differentiates TODDD™ from other sustained delivery technologies in development?
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Fast, easy, painless replacement
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Less than a minute, no applicators, tools, or instruments needed
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No anesthetization
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Replaceable by support staff, caregiver or even patient
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No professional equipment or facility required
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Much lower delivered treatment cost
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Non-invasive – strong patient preference
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Greater drug payload capacity – longer delivery duration
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Can deliver multiple drugs simultaneously
Current State of Development
Substantial progress has been made in the areas of polymer formulation development, drug release studies and prototype device development. The development can be summarized as follows:
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Successful incorporation of a wide variety of drugs into TODDD™ polymer matrices: including prostaglandin, timolol, prednisolone, atropine, dexamethasone, brimonidine and ibuprofen. These drugs were chosen to demonstrate the feasibility of incorporating drugs with varying chemical structures.
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In vitro drug release studies demonstrating its ability to create consistent drug release profiles over many months.
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Ocular insert prototypes that have gone through physicochemical and preliminary preclinical testing.
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Completed a single human subject 6-month timolol study – One TODDD™ provided uninterrupted non-invasive, continuous drug delivery with therapeutic response for over 180 days
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Completed a single human subject atropine study - One TODDD™ provided uninterrupted non-invasive, continuous drug delivery while preserving normal pupil function and focal accommodation for over 60 days.
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Development of a cast-molding process for successful prototype production.
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Animal feasibility studies in rabbit and dog showing sustained drug release and efficacy over extended periods.
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Human clinicals without drug demonstrating one month continuous wear (24/7) at New England College of Optometry.
TODDD™ with drug depots
Drug throughout TODDD™