Biological Activity Assay and Bioanalytical Test Method Development for a Silk-Derived Protein (SDP) Eye Drop Product

The company has developed a silk-derived protein (SDP) for use as a novel ophthalmic formulation excipient that will help to treat the ocular injuries and dry eye pathology that affects over 40 million Americans annually and hundreds of millions of people worldwide. The SDP excipient is designed to enhance tear formulation comfort, longevity, and overall ocular health. This proposal builds on the research and development efforts that have developed the SDP excipient for use on the ocular surface, and the funded work will include efforts to optimize GMP manufacturing of the excipient into a powder form for ease of formulation production, development of a SDP-containing artificial tear formulation, and manufacturing and packaging of single-use units of the tear formulation. Safety and stability testing will also be completed under this proposal for both the excipient and final formulation. The SDP product will become a first-in-class protein excipient that will help meet the critical yet unmet shortcomings of a worldwide health concern with regards to ocular injury and dry eye syndrome.