Background
Dry eye is an oftentimes debilitating condition characterized by severe irritation and damage to the eyes. Depending on the diagnostic criteria used, it is estimated that up to 1 in 3 people will suffer from dry eye, which precipitates a market that is projected to hit over $7 billion dollars by 2025. Currently, there are only two FDA approved prescription eye drop treatments for dry eye in the United States (Restasis® and Xiidra®). These treatments have limited efficacy and necessitate the use of eye drops numerous times a day, which results in issues with patient compliance. As with any eye drop formulation, product loss is a huge issue (product falls out of eye and/or drains away from eye through tear ducts), and the therapeutic agent is only in contact with the ocular surface for a very short amount of time, leading to lack of effectiveness. Our product, the CyteSolutions Lens, is a contact lens based platform that makes use of a special coating that allows for a slower, sustained delivery of a novel drug only when in contact with the ocular surface.Technology Description
Developed at the McGowan Institute for Regenerative Medicine in conjunction with clinical experts from the University of Pittsburgh Medical Center’s Eye & Ear Institute, the CyteSolutions Lens is a soft lens-based therapy and features use of a low-dose, sustained, locally releasing drug, providing convenient application with a familiar modality and long-term relief of symptoms. Unlike Restasis®, Xiidra®, and over the counter tear substitute eye drops, our therapy can conveniently be applied infrequently overnight, potentially providing days-long relief. Laboratory in-vitro tests have also shown ability of the CyteSolutions Lens to release active ingredient for days, and this should reduce frequency of treatment and create longer lasting symptom relief, as the CyteSolutions Lens releases a drug that targets a novel underlying pathway of dry eye inflammation not previously targeted in currently available therapies. Advantages
* Sustained release over days
* Effective local drug release using least amount of drug
* Use of natural and safe biomaterials
* Targets inflammation at earlier stages than current therapies
* Less product loss
* Familiar modality
* Potential for overnight use
* Lower frequency of use (relative to the frequent dosing regimen of eye drops)
* Potential to change underlying course of the disease, providing for long-term relief of symptomsApplications
* Treatment and management of the symptoms of dry eye
* Drug release platform can be extended to include other drugs for additional applications such as release of therapeutics for the prevention of infection after surgery and release of therapeutics for the treatment of glaucomaStage of Development
We have made significant progress on proof-of-concept in vitro aims. Preclinical animal testing is projected to begin May 2019.IP Status
Multilayer Coating for Drug Delivery from Contact Lenses
U.S. Patent Application No.: 62/815,888
Filed March 8th, 2019
Potential opportunity for separate patents and FDA approval pathways for the lens as a device and the medication as a drug.Notable Mentions
* Recipient of a University of Pittsburgh Center for Medical Innovation Early-Stage Medical Technology Research and Development 2018 Pilot Funding Program Grant (20k)
* McGowan Institute 2019 Scientific Retreat Scientific Poster Contest – 1st place Medical Devices Category
* McGowan Institute 2019 Scientific Retreat Scientific Poster Contest – 1st place Cellular Approaches to Tissue Engineering and Regeneration CategoryInnovators
Alexis Nolfi
PhD candidate, Department of Bioengineering, University of Pittsburgh
Cellular Approaches to Tissue Engineering and Regeneration (CATER) Trainee, National Science Foundation GRFP Fellow, McGowan Institute for Regenerative Medicine
Ms. Nolfi is involved in numerous research projects centered on the immune system’s role in the pathogenesis of disease and how to modify an immune response to biomaterials, with a distinct focus in ocular and women’s health applications. Her undergraduate work is from the University of Pittsburgh with degrees in bioengineering, psychology, and chemistry. Aside from her many research endeavors, she has a passion for STEM-centered outreach and teaching, with instructional experience ranging from middle school through college-level students.Mangesh Kulkarni, MD, PhD
Assistant Professor, Department of Bioengineering, University of Pittsburgh
Dr. Kulkarni’s research focuses on the development of biomaterials-based tissue engineering systems for delivering therapeutic biomolecules and cells for tissue repair and regeneration, and he is pursuing work on molecular diagnostics and therapeutics, especially non-coding RNA, and cell-free therapeutic strategies.Bryan Brown, PhD
Associate Professor, Department of Bioengineering; Department of Obstetrics, Gynecology, and Reproductive Service; Clinical and Translational Science Institute, University of Pittsburgh
Chief Technology Officer, Renerva LLC
Adjunct Assistant Professor of Clinical Sciences, Cornell University College of Veterinary Medicine
Director of Educational Outreach, McGowan Institute for Regenerative Medicine
The focus of Dr. Brown’s laboratory is upon clinical applications where few effective solutions currently exist, with increasing emphasis upon unmet clinical needs in women’s health, and seeks to develop context-dependent biomaterials for regenerative medicine therapy while developing a deeper understanding of the host inflammatory response in injury and disease.Vishal Jhanji, MD
Professor of Ophthalmology, Cornea, Cataract, and External Disease Services, Refractive Surgery Service, University of Pittsburgh School of Medicine
Dr. Jhanji’s research interests include the pathogenesis, etiology, and treatment of dry eye; genetics, management, and outcomes of keratoconus; diagnosis and management of external eye disease in corneal infections; corneal transplantation, and imaging of the cornea.