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Clinical Trials

At Stuart Therapeutics, we are committed to developing differentiated and effective therapies for people living with chronic diseases of the eye. We are strong believers in the informed consent process, whereby patients gain a full understanding of the risks and benefits of participating in a clinical study for one of our drug candidates.

Please go to clinicaltrials.gov to learn more about participating in clinical trial studies, including the informed consent process, eligibility, risks and benefits of participation, and questions to ask.

Learn more about Stuart Therapeutics – sponsored clinical trials below.

Dry Eye Disease

COMPLETED

A Phase 2 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Safety and Efficacy of ST-100 Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease

RECRUITING

A Phase 3 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease

PARTNERING

Join Our Team

Stuart Therapeutics controls the exclusive worldwide rights to the PolyCol technology and associated patents for human therapeutic use in ophthalmology through license. At Stuart Therapeutics, we are committed to the development of important new innovations in therapeutics for chronic ophthalmic indications. We are interested in strategic partner relationships that will extend and accelerate our impact.

Executive Chairman
Robert O. Baratta, MD

Robert O. Baratta was a highly respected senior executive, leader, and innovator, and was a practicing ophthalmologist in South Florida for over 40 years. He has held leadership and advisory positions with the Florida Society of Ophthalmology, the American Academy of Ophthalmology, and the Vanderbilt University Eye Institute. He is also an accomplished entrepreneur, having served as Chief Executive Officer of Ascent Surgical Partners, an ambulatory surgery center management company, and Chairman of MedAmerica HealthCare Suppliers, a medical supplies company exporting to Central America. Dr. Baratta received his MD from Columbia University College of Physicians and Surgeons. He was elected to the Board of Directors of FPIC Insurance Group in 1996 and was elected its Chairman in 1999. FPIC Insurance Group was listed on the NASDAQ exchange (NASDAQ: FPIC) until its sale in 2010. Dr. Baratta was responsible for the turnaround of that business, its subsequent sale and successful return of value to shareholders.

Chief Medical Officer
Jodi Luchs, MD, FACS

Dr. Luchs graduated from the University of Pennsylvania in 1987 and received his M.D. in 1991 from the Albert Einstein College of Medicine in New York. He completed an internship at the Mount Sinai Medical Center, and his Ophthalmology residency at Long Island Jewish Medical Center. He was a fellow in Cornea/External Disease at Wills Eye Hospital.

Dr. Luchs is Board Certified by the American Board of Ophthalmology, and a Fellow of the American Academy of Ophthalmology, and the American College of Surgeons. He is also a member of the Castroviejo Corneal Society, and a founding member of both the American-European Congress of Ophthalmic Surgery (AECOS) and the Society of Cornea, External Disease and Refractive Surgeons (CEDARS).

He has numerous publications on cornea, external diseases, and refractive surgery to his credit, including 2 books, and has lectured nationally, and internationally. In 2015, he received the American Academy of Ophthalmology’s Achievement award.

President and CEO
Eric Schlumpf

Eric Schlumpf has extensive startup, early stage and large public company leadership experience. His background includes leadership roles in a variety of industries, including health care, telecommunications and high tech. Eric was recently CEO of PathMD, an early-stage pathology laboratory company based in Los Angeles, which grew to become the premier pathology provider in the market during his tenure. Prior to PathMD, Eric was a VP and General Manager for T-Mobile USA; responsible for its largest and most important US market. He was a founder of Archstone Consulting, an international consulting firm, and he was a partner with Deloitte and Touche, where he advised several multinational pharmaceutical, health care and technology companies. Eric holds a Bachelor of Science in Electrical Engineering from Texas A&M University, and an MBA from TCU. He has completed additional post-graduate studies at Southern Methodist University and the University of California, San Diego.

Executive VP, Research & Development
Brian J. Del Buono, Ph.D.

Brian Del Buono has nearly 35 years of multinational R&D and business development experience in FDA-regulated pharmaceuticals and biologics, with an emphasis in biotech/pharma R&D innovation and management on both branded and generic FDA-regulated products. His academic and corporate research focused on cell structure and function, particularly interactions between the cell surface and the extracellular matrix (ECM). His experience includes research on the interactions between ECM components and their effects upon cellular function, particularly interactions between various collagen types and non-collagen ECM components. Brian holds a B.S. in Microbiology (Chemistry minor) from Juniata College and an M.S. and a Ph.D. in Microbiology/Biochemistry from Pennsylvania State University and was a postdoctoral fellow and on the faculty of Boston University School of Medicine.

Don Stires

Don Stires has over 40 years of experience in general management and finance with medical device, pharmaceutical, and consumer products companies as well as small company start-ups. His background includes acquisitions and strategic partnering situations, management of supply chain and first to market product development organizations.

He spent over 20 years with the Johnson and Johnson Family of Companies, including Ethicon, J&J Interventional Systems, and Cordis, in both CFO and Product Development roles. Don also held CEO, COO and CFO roles in several startup organizations in life sciences, and he has a broad, multi-disciplinary perspective.
Don has a B.S. in Civil Engineering from Lehigh University, and an MBA from Columbia University.

Charles Wykoff, MD PHD

Charles C. Wykoff MD PhD is Director of Research, Retina Consultants of Texas; Chairman of Research and Clinical Trials Subcommittee, Retina Consultants of America; Deputy Chair for Ophthalmology, Blanton Eye Institute and Associate Clinical Professor of Ophthalmology, Weill Cornell Medical College, Houston Methodist Hospital, Houston Texas.
He received his baccalaureate from MIT, PhD from Oxford University while on a Marshall Scholarship, and MD from Harvard Medical School. He completed ophthalmology residency and vitreoretinal fellowship at Bascom Palmer Eye Institute where he served as Chief Resident & Co-Director of Ocular Trauma and received a Heed Fellowship and the Ronald G. Michels Award.

Dr. Wykoff is passionate about translational research and clinical trial design, and serves as principal investigator for numerous national clinical trials. He has published over 250 peer reviewed manuscripts and frequently speaks at national and international academic meetings. His research interests pertain to angiogenesis, retinal vascular diseases, atrophic retinal diseases, cell and gene therapy applications, and vitreoretinal surgical topics. He has been awarded the AAO Secretariat and Achievement Awards as well as the ASRS Young Investigator Award, Honor and Senior Honor Awards.
He is active on the ASRS Board of Directors where he serves as Chair of the Practice Management Committee. He is President (2021-2023) of the Vit-Buckle Society. He is also an elected member of the Retina Society and Macula Society, was a founding member of the Ophthalmology Retina Editorial Board and is the Chief Medical Editor for Retina Specialist.

Dr. Wykoff serves on multiple scientific and medical advisory boards, safety monitoring committees, and global steering committees for retina endeavors spanning the innovative process from early to late-stage developments. He is foundationally involved with entrepreneurial activities focused on bringing the value of clinical trials to new centers across the globe, on improving the efficiency of clinical trial design, and on optimizing the quality of data collected from prospective studies. His guiding philosophy is to build and strengthen innovative, ethical teams focused on developing new approaches to improving outcomes for patients with blinding diseases.

Dr. Sheri Rowen, MD

Dr. Sheri Rowen is widely recognized key opinion leader, expert in ocular surface and refractive indications, and is a practicing ophthalmic surgeon in Newport Beach, California. Dr. Rowen has worked as a researcher, pioneering new treatments and techniques for ocular surgery, and is a Principal Investigator for numerous FDA therapeutics and device trials. Dr. Rowen is a Diplomat and Fellow of the American Board of Ophthalmology, a Member of the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, the American College of Surgeons, and is a Vice-President of the International Association of Women Eye Surgeons. She earned her medical degree from the University of Maryland and completed her surgical internship and fellowship at Johns Hopkins Hospital and a two-year vitreoretinal research fellowship at the Wilmer Eye Institute. Dr. Rowen acts as President Emeritus of Cedars Aspens Society and serves on the Medical Editorial Board of CRST and Presbyopia Physician. Dr. Rowen has appeared in numerous television interviews discussing her insights on refractive and ocular surface disease indications. She has published a numerous research papers on ophthalmic surgery and regularly speaks at ophthalmology conferences both in the US and abroad.

Peter K. Kaiser, M.D.

Peter K. Kaiser, M.D. graduated magna cum laude with Highest Honors from Harvard College and magna cum laude from Harvard Medical School. He completed an internal medicine internship at Massachusetts General Hospital, an ophthalmology residency at the Massachusetts Eye and Ear Infirmary, and a vitreoretinal fellowship at Bascom Palmer Eye Institute where he was awarded a Heed Ophthalmic Fellowship , before joining the vitreoretinal department of the Cole Eye Institute at the Cleveland Clinic Foundation, Cleveland, Ohio where he is the Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine.

As a National Eye Institute and National Institute of Health RO1-funded principal investigator, Dr. Kaiser leads a team involved in the evaluation of vascular biology in age-related macular degeneration (AMD) and diabetic retinopathy (DR). In addition, Dr Kaiser is actively involved in clinical research having served as Study Chairman for numerous major, multi-center, international clinical trials, and principal investigator in over 60 trials evaluating new treatments for AMD, DR, and other retinal disorders. He is the director of Center for Ocular Research and Evaluation (CORE). Dr. Kaiser has been honored to receive the Lew R. Wasserman Award from the Research to Prevent Blindness and the Macula Society’s Young Investigator Award. Complementing his research endeavors, Dr. Kaiser serves on numerous scientific advisory boards and addresses his research interests as an invited speaker at national and international conferences. He is a major contributor to the medical literature having authored 7 textbooks, 30 book chapters, and more than 400 peer-reviewed manuscripts. He is Editor-in-Chief of Retinal Physician, Associate Editor of International Ophthalmology Clinics, and serves on the editorial boards of American Journal of Ophthalmology, Retina, Retina Today, and Ocular Surgery News. Dr. Kaiser has been recognized by American Society of Retina Specialists Honor and Senior Honor Awards, along with the American Academy of Ophthalmology Achievement, Senior Achievement, and Lifetime Achievement Awards. He has been listed as one of the “Best Doctors in America” every year since 2002 and named one of the “150 Top Innovators in Retina” by Ocular Surgery News, selected as a charter inductee of the Retina Hall of Fame in 2017, and appeared on the biannual Ophthalmologist’s “Power List” in 2016, 2018, and 2020 as one of the top 100 most influential people in the world of ophthalmology. He is the team ophthalmologist for the Cleveland Cavaliers (National Basketball Association).

Chief Science Officer
David Calkins, PhD.

David Calkins, Ph.D., serves as Stuart Therapeutics’ Chief Science Officer, and is the Vice-Chairman and Director for Research for the Vanderbilt Eye Institute and the Denis M. O’Day Professor of Ophthalmology and Visual Sciences for the Vanderbilt University School of Medicine, where he has been a member of the faculty since 2004. He also is Director of the Vanderbilt Vision Research Center, home to over 50 vision scientists. Professor Calkins completed his Bachelor of Science in Pure Mathematics from the University of Michigan Honors College, and his Doctorate in Neuroscience from the University of Pennsylvania School of Medicine. Professor Calkins is a leading authority on the neurobiological basis of vision loss in blinding eye disease, neuroprotection and regenerative medicine for conditions that affect the retina and early visual pathways. He is also a recognized authority in the synaptic organization of the retina and early visual pathways as it relates to structure-function relationships and visual perception.

Ronald T. Raines, PhD.

Ronald T. Raines, Ph.D., is the Firmenich Professor of Chemistry at the Massachusetts Institute of Technology, an Associate Member of the Broad Institute of MIT and Harvard, and an Affiliate of the Koch Institute for Integrative Cancer Research at MIT. From 1989-2017, he was on the faculty at the University of Wisconsin-Madison. Dr. Raines is a leading expert on the chemistry of collagen, which is the most abundant protein in the human body. Using collagen mimetic peptides, he revealed the underlying basis for the structure and stability of collagen. By applying these insights, he created synthetic collagens that are stronger and longer than any found in Nature. His work on collagen has been supported by the NIH and Arthritis Foundation, and has led to numerous awards, including the Ralph F. Hirschmann Award in Peptide Chemistry and Arthur C. Cope Scholar Award from the American Chemical Society, the Vincent du Vigneaud Award and Rao Makineni Lectureship from the American Peptide Society, and the Emil Thomas Kaiser Award from the Protein Society. Dr. Raines is an inventor on over 50 US patents, and provides Stuart Therapeutics with cutting-edge knowledge on the design, synthesis, and utility of collagen mimetic peptides.

Jay Pepose , MD.

Dr. Jay Pepose is the Founder and active Medical Director of the Pepose Vision Institute. He also serves as Professor of Clinical Ophthalmology at Washington University School of Medicine and Barnes-Jewish Hospital. He is a noted specialist in cataract, corneal and vision correction surgery.

A pioneer in laser eye surgery to correct nearsightedness, farsightedness and astigmatism, Dr. Pepose was one of an elite group of eye surgeons that conducted the nationwide clinical trial of the LASIK procedure for the correction of farsightedness and astigmatism. Dr. Pepose is involved in numerous clinical trials related to emerging implants, procedures and therapies for cataracts, glaucoma and other vision related conditions.

Dr. Pepose is the recipient of numerous honors and awards, including the prestigious Cogan award from the Association for Research in Vision and Ophthalmology.

Dr. Pepose has contributed extensively to the scientific literature, holds two patents, and has been the recipient of competitive National Eye Institute research support. He serves on the editorial board of several prestigious ophthalmology journals and is associate editor of The American Journal of Ophthalmology.

Dr. Pepose earned his medical degree and Ph.D. from UCLA and completed his residency in ophthalmology at the Wilmer Institute, Johns Hopkins Medical Institutions, the premier ophthalmology program in the country. He completed his subspecialty training in cornea and external diseases at Georgetown University Medical Center.

Ed Holland, MD.

Dr. Holland is the Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. He attended the Loyola-Stritch School of Medicine in Chicago and trained in Ophthalmology at the University of Minnesota. He completed a fellowship in cornea and external disease at the University of Iowa, and then completed a second fellowship in ocular immunology at the National Eye Institute, National Institutes of Health in Bethesda, Maryland. He returned to serve as Director of Cornea and Refractive Surgery Service at the University of Minnesota. He was promoted to the position of Professor and was granted the Elias Potter Lyon Chair in Ophthalmology. He also served as President of the Minnesota Academy of Ophthalmology.

Dr. Holland formerly served as the President for the American Society of Cataract and Refractive Surgery from 2011-2012. He was also a member of the Executive Committee and now serves as the Program Chair. Dr. Holland was a former member of the Board of Trustees for the American Academy of Ophthalmology. He has also been the Secretariat of the Annual Meeting for the American Academy of Ophthalmology. He was awarded the Life Achievement Honor Award at the 2012 American Academy of Ophthalmology Annual Meeting. Dr. Holland has served as the Chair of the Eye Bank Association and was the former Chair of the Medical Advisory Board for the Eye Bank Association of America. He is the past President of the Cornea Society and previously served on its Board of Directors.

Dr. Holland has been awarded the Castroviejo Award from the Cornea Society in 2013. He has also received both the Senior Achievement Award and The Honor Award from the American Academy of Ophthalmology. He was awarded the Binkhorst Medal by the American Society of Cataract and Refractive Surgery in 2008. He was a recipient of the 2002 Paton Society Award given by the Eye Bank Association of America. Among other honors, Dr. Holland has been listed in the “Best Doctors in America.” He has a national and international reputation for his knowledge and expertise in the field of cornea and external disease. He is frequently invited to attend lectures both nationally and internationally. Dr. Holland is the author of over 200 articles in peer review journals and has edited Cornea, the most widely read textbook on corneal disease and surgery.

As the Director of Cornea Services at the Cincinnati Eye Institute, Dr. Holland has attracted worldwide referrals for medical and surgical corneal problems and for stem cell transplantation. His clinical interests include Corneal Transplantation, Cataract Surgery, Ocular Surface Transplantation, and Refractive Surgery.

Vance Thompson, MD.

Vance Thompson, MD, graduated from Gregory High School in Gregory, South Dakota, and subsequently went on to complete his education at the University of South Dakota (BS-Chemistry), University of South Dakota School of Medicine (MD), Avera McKennan Hospital in Sioux Falls, South Dakota (Internship), University of Missouri – Columbia (Ophthalmology Residency), and Hunkeler Eye Clinic (Refractive Surgery Fellowship with Daniel S. Durrie, MD). Dr. Thompson has been practicing refractive, corneal and cataract surgery in Sioux Falls, South Dakota since 1991 and is a Professor of Ophthalmology at the University of South Dakota Sanford School of Medicine. Dr. Thompson has been primary investigator in over 50 FDA-monitored clinical trials studying laser (excimer, holmium, and femtosecond) and implant (pseudophakic, phakic, and corneal inlay) vision correction since 1990. He was the Medical Monitor of the first FDA approved ophthalmic use of an excimer laser in the United States. He has also been the Medical Monitor of other studies and most recently was the co-monitor of Avedro’s corneal collagen crosslinking trial which was recently FDA approved. Dr. Thompson has numerous publications, including being a co-editor of the textbook Refractive Surgery and lectures and teaches throughout the world on refractive surgery. Dr. Thompson has numerous community interests which include serving on the Boards of the University of Sioux Falls, Sanford Health Foundation, the South Dakota Symphony, DakotaCare, US Bank, University of South Dakota, US Bank, a presidential appointment to the President’s Advisory Council for the Performing Arts in Washington, DC for 8 years during the Bush administration, and more.

Executive Vice President, Program Management
Shawn DeLorey

Shawn DeLorey oversees Stuart Therapeutics operations and corporate development activities. He has extensive experience managing enterprises in heavily regulated industries, including the life sciences and pharmaceutical sectors; and a functional background in: business strategy and corporate development; supply chain and operations management; product development and growth; regulatory compliance and quality management; and sales and marketing. He has worked in companies ranging from venture-funded startups to private and publicly held major corporations in the US and abroad, and has a track record for delivering results. Shawn is an inventor of PolyCol, and has held senior executive and operating management roles such as: SVP at US Foods; VP, Business Development at GEN3 Partners; Principal at A.T.Kearney and Arthur Andersen; and Vice President at Foxcode Operations Advisors.

Chairman of Compensation Committee
Walter Flamenbaum, MD

Walter Flamenbaum, M.D., is a Managing Director of The Channel Group since 2014. Prior to that he was one of the Founding Partner of Paul Capital Healthcare Funds, which has invested over $1 billion in forty investments, and is currently a Partner Emeritus at Paul Capital. He led the development and refinement of its investment strategy, processes and techniques, as well as actively participating in the majority of the Fund’s investments, including roles in sourcing, negotiating and other activities. He was primarily responsible for the development of the diverse team of healthcare and financial investment professionals, allowing for the Fund’s development and successes to date. Dr. Flamenbaum has 40 years of healthcare experience, including the development and evaluation of pharmaceutical and biotechnology-based drugs, medical devices and diagnostics. He is board certified in internal medicine, nephrology and clinical pharmacology and was a professor of medicine at the Mt. Sinai School of Medicine and Tufts University School of Medicine.

Felipe A. Medeiros, M.D., Ph.D

Felipe A. Medeiros, M.D., Ph.D. is Distinguished Professor of Ophthalmology and the Joseph AC Wadsworth Endowed Chair at Duke University. He is also Vice-Chair for Technology and the Director of the Clinical Research Unit, where he leads clinical research efforts in the Department of Ophthalmology. He is also Professor of Electrical and Computer Engineering at the Pratt School of Engineering at Duke.
Dr. Medeiros’ research has been focused on the development of innovative methods and technologies for early diagnosis and detection of glaucoma progression, the main cause of irreversible blindness in the world. His laboratory has pioneered the use of technologies such as virtual reality to investigate functional outcomes in ophthalmology. More recently, his work has focused on how artificial intelligence can improve screening, diagnosis and monitoring of eye diseases. He has published over 400 peer-reviewed scientific articles and 6 books in ophthalmology. His publications have received over 22,000 citations, for an h-index of 81. His research has been funded by the National Institutes of Health (NIH) and through many other public and private institutions.
Dr. Medeiros has been the recipient of several international awards, including the Cogan Award from the Association for Research in Vision and Ophthalmology (ARVO), the World Glaucoma Association Research Award, the American Academy of Ophthalmology (AAO) Senior Achievement Award, American Glaucoma Society Clinician-Scientist and Mid-Career Awards, among many others. Most recently, he received the Moacyr Alvaro Gold Medal, the most prestigious award in Ophthalmology in Latin America. He has trained numerous students, fellows and postdocs from many parts of the world.

Chairman of Audit Committee
Diane Black

Congressman Black’s faith in America’s promise was shaped from an early age. The middle daughter of Great Depression-era parents, Diane spent the earliest years of her life in public housing and would go on to become the first person in her family to earn a college education. As a registered nurse, small businesswoman, and former educator, Diane Black brought a unique and dynamic perspective to her work as a legislative leader in both Tennessee and Washington. In Congress, Diane served as Chairman of the House Budget Committee, where she worked to draft the 2018 fiscal year budget that cut millions of dollars in wasteful spending and confronted the crippling debt burden in Washington. Diane also served on the House Ways and Means Committee and led efforts to reform the U.S. tax code for the first time in over three decades. Through her over 40 years of experience working in the healthcare field, Diane learned first-hand about the importance of high-quality care and the obstacles faced by patients, health care providers, and employers. Her real-world experiences as a nurse have uniquely positioned her as a credible and effective leader on healthcare policy and the life issue. A former Tennessee Right to Life legislator of the year, she is a steadfast champion for the rights of the unborn.