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Minimize RSR Award Detail

Research Spending & Results

Award Detail

Awardee:SILK TECHNOLOGIES, LTD.
Doing Business As Name:SilkTears, Inc.
PD/PI:
  • Brian D Lawrence
  • (617) 272-0691
  • brianlawrence@silktears.com
Award Date:04/06/2012
Estimated Total Award Amount: $ 449,696
Funds Obligated to Date: $ 1,111,614
  • FY 2012=$449,696
  • FY 2013=$39,981
  • FY 2014=$89,938
  • FY 2015=$515,999
  • FY 2016=$16,000
Start Date:04/15/2012
End Date:03/31/2017
Transaction Type:Grant
Agency:NSF
Awarding Agency Code:4900
Funding Agency Code:4900
CFDA Number:47.041
Primary Program Source:040100 NSF RESEARCH & RELATED ACTIVIT
Award Title or Description:SBIR Phase II: Regenerating Ocular Surface Wounds with Novel Biomaterial
Federal Award ID Number:1152561
DUNS ID:079337666
Program:SBIR Phase II
Program Officer:
  • Ruth Shuman
  • (703) 292-2160
  • rshuman@nsf.gov

Awardee Location

Street:1886 Berkshire Lane North
City:Plymouth
State:MN
ZIP:55441-3723
County:Minneapolis
Country:US
Awardee Cong. District:03

Primary Place of Performance

Organization Name:Joan & Sanford I. Weill Medical College of Cornell University
Street:1300 York Avenue
City:New York
State:NY
ZIP:10065-4805
County:New York
Country:US
Cong. District:12

Abstract at Time of Award

This Small Business Innovation Research (SBIR) Phase II project will result in a bandage that accelerates wound healing to the surface of the eye. Eye wounds are extremely painful, can cause vision loss, and may fail to heal on their own. Trauma may occur due to household cleaning agents, traumatic impact from a falling object, or removal of a contact lens. Ocular surgeries, such as cataract and refractive surgeries, are also sources for corneal injury. Delays in healing may lead to scarring and permanent visual loss. This project will lead to the first biodegradable "green" corneal bandage that accelerates corneal healing. The bandage resembles a contact lens. When this bandage is placed on a wounded eye it reduces inflammation and stimulates the healing process. It is made of a novel biomaterial, which can be programmed to "dissolve" within hours to days providing patients with a tailored product. Completed work from Phase I demonstrated the corneal bandage significantly accelerated corneal healing rate. During Phase II further development will ready the product for human clinical trials. Results from Phase II will produce the final product design, quality system implementation, and initial development of a GMP manufacturing process. The broader impact/commercial potential of this project will help the 2 million Americans that sustain traumatic injuries to the cornea each year, and the 4 million Americans that undergo surgery annually leaving the cornea wounded. Such corneal wounds cause intense pain and may lead to blindness depending on the severity. This new eye bandage accelerates corneal healing and adheres to the surface of the eye to aid in alleviating pain. The bandage is inexpensive and will result in a less expensive procedure for treating cornea trauma resulting in millions in savings to the American health care system, while allowing for the expansion of the point of care environments (i.e. clinic, home use, hostile environments). Production is fully scalable to large quantities, and can be easily packaged and distributed in a similar fashion as a contact lens. Furthermore, the eye bandage is an innovative technology, patented, and new to the medical device industry.

Publications Produced as a Result of this Research

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Abdel-Naby W, Cole B, Liu A, Liu J, Wan P, Guaiquil VH, Schreiner R, Infanger D, Lawrence BD, Rosenblatt MI. "Silk-Derived Protein Enhances Corneal Epithelial Migration, Adhesion, and Proliferation" Investigative Ophthalmology and Visual Science, v.58, 2017, p.1425. doi:10.1167/iovs.16-19957 


Project Outcomes Report

Disclaimer

This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.

There is a significant clinical need to improve current therapeutic approaches to treat ocular wounds and dry eye related ailments.  Silk Technologies, Ltd. (SilkTech) has developed the novel silk-derived protein (SDP) product from the naturally occuring silkworm cocoon.  SDP is the first commercially available protein ingredient for use in enhancing the wetting profile of eye drop formulation on the ocular surface.  Enhanced wetting leads to better formulation spreading on the cornea to provide a more comfortable and longer lasting eye drop (see image).  The enhanced wetting properties are accomplished through SDP’s amphiphilic chemistry, in which the protein acts as an interface (i.e., mucin protein-like) between the hydrophobic corneal surface and the aqueous tear film. This in turn increases the formulation’s ability to enhance the eye drop patient experience through increased comfort and promote regenerative healing of the damaged ocular surface. Most importantly, SDP is very unitque in that it is highly soluble in water and has a demonstrated long-term shelf-life stability of multiple years when added to aqueous formulations.  These properties are not possible with native silk protein, and thus these material improvements represent a significantly novel achievement in regards to silk-based material development.  In addition to finding utility in eye drops, such properties are useful when producing products requiring protein ingredients that must not form aggregates, gel, or promote microbial growh (e.g., biopharmaceuticals, cosmetics, foods, beverages).

When SilkTech began work on the SDP technology the company was a fledgling startup of 2 people with the idea that silk proteins could be utilized to benefit patient ocular health in ways that had not been previously addressed.  Through the course of the NSF SBIR program the company grew into a fully operational commercial entity with a product that offers significant benefits to the ophthalmic community worldwide.  The company developed and proved the foundational SDP technology, successfully scaled the process, and found a commercial market to supply.  Most significantly, this program allowed for the development of a scalable commercial producion process of the SDP material. During the course of this program the company was able to take a traditional bench-top process that could produce approximately a few grams of material per week, to a process that capable of producing metric tons in the same time period.

The SDP technology will provide a significantly benefiicial impact to vision health, but more importantly the work here, in part, has produced a commercially capable production process of a raw protein material source that did not exist previously.  The SDP technology represents a significant step forward in taking a material used by humans for millenia, silk, to a new set of commercial appications through both an environmentally sustainable and green process approach.  It is the SilkTech's vision to one day provide silk-derived protein as an ingredient offering that is as ubiquitous to whey or soy today.


Last Modified: 04/17/2017
Modified by: Brian D Lawrence

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