* A Demonstration of TODDD™:
Research & development facilities: Amorphex currently has research facilities in Andover and Lowell, MA. The facilities in Lowell are at a high tech incubator at the University of Massachusetts-Lowell, the Massachusetts Medical Device Development Center, also known as M2D2 . The facilities there include the company’s new chemical laboratory which is capable of polymerization, analytical evaluations and glove box casting. Amorphex also has access to the University’s Plastics Engineering Department which is capable of prototype tool production, lathing & injection molding. The access to these facilities is through a contract that provides further access to chemical and engineering facilities at the University.
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:
– Successful incorporation of a wide variety of drugs into polymer metrics: including prostaglandin, timolol, prednisolone, dexamethasone, brimonidine and ibuprofen. These drugs were chosen to demonstrate the feasibility of incorporating drugs with varying chemical structures.
– In vitro drug release studies demonstrating its ability to create consistent drug release profiles over many months.
– Ocular insert prototypes that have gone thru physico-chemical and preliminary preclinical testing.
– 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
– Development of a cast-molding process for successful prototype production.
– Animal feasibility studies in rabbit and dog showing sustained drug release and efficacy over extended periods.
– Human clinicals without drug demonstrating one month continuous wear (24/7) at New England College of Optometry.