Product Development


DEVELOPMENT ACTIVITIES

Through Phase I and Phase II SBIR Grant Awards, Vista Scientific has developed and combined two unique drug delivery technologies that can resolve several ophthalmic pharmaceutical therapy issues. The first is a controlled release platform technology that is based on novel polymeric materials. This non-erodible solid matrix material delivers a variety of active agents over extended periods of time (90+ days).

Vista has incorporated these materials in its second technology, a proprietary device called TODDD™ (Topical Ophthalmic Drug Delivery Device) that is designed for sustained topical drug delivery to the eye. TODDD’s innovative design allows for its comfortable retention in the eye for months at a time. It is worn completely concealed under the eyelid.

The application that Vista’s team has focused on through the grant awards has been the sustained delivery of timolol for the treatment of glaucoma. Competing Renewal Grant applications are now accepted by the NEI to continue the process of developing technologies into products that ultimately require federal regulatory approval. Vista was awarded a Phase II Competitive Renewal Award to carry the product forward to human feasibility clinical trials, by establishing manufacturing processes, testing and controls, and building product in a manner compliant with requirements of the FDA for Phase I studies.

Vista has also been active in developing TODDD to deliver prostaglandins for the potential treatment of glaucoma. Early development of additional applications includes work on steroidal and non-steroidal anti-inflammatories, antibiotics, and the incorporation of nanosphere delivery systems.

A separate LLC, Amorphex Therapeutics LLC, has been set up, involving substantially the same ownership as Vista Scientific LLC, to focus exclusively on developing and licensing the TODDD™ technology for specific drugs and applications.

Another notable technology developed by Vista under SBIR phase I & II grants is a glycoprotein-based compound, Milcin, which underwent preclinical and FDA Phase I/II IND clinical evaluations for the treatment of dry eye with favorable initial results. Subsequent clinical studies have indicated the need to secure a supplier capable of cGMP commercial production of the active ingredient for this product.

 


Ophthalmic Drug Delivery (TODDD) Demonstration:




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