NATURAL THERAPY FOR OCULAR SURFACE DISEASE

TearSolutions has developed LacripepTM, a proprietary first-in-class peptide therapy

Developing Potentially Disruptive Therapies for the Treatment of Ocular Surface Related Diseases

Background

The quality of human tear film is critical for corneal epithelial and neuronal cells’ survival. Several tear proteins are deficient in ocular surface related diseases. One, called Lacritin, is deficient in most forms of ocular surface disease and, when reintroduced, health is restored.

Lacripep, which is derived from the Lacritin protein, is a first-in-class topical therapy that preserves all of Lacritin’s bioactivity.

Ocular Surface Disease

OSD is an under-diagnosed and under-treated disease that continues to be exacerbated by the following: 1) increased age, with women being particularly susceptible due to the hormonal changes that occur as they age, 2) environmental factors, such as poor air quality, and 3) staring at computer screens for long periods of time.

Our Solution - Lacripep

TearSolutions’ founder and Chief Scientific Officer, Dr. Gordon Laurie, discovered ‘Lacritin’, a naturally occurring tear protein that is selectively deficient in most forms of ocular surface disease.  From this discovery, he developed Lacripep, which preserves all of the biological activity of Lacritin in a short stable peptide that can be produced at scale.  Preclinical data showed that, when Lacripep was added topically in animal models, it restored basal tearing without irritation and healed the corneal surface of the eye.
TearSolutions has now completed a first-in-human Phase I/II trial in primary Sjögren’s Syndrome, who typically have a severe and often debilitating form of ocular surface disease and are known to be deficient in Lacritin.  The results showed a rapid improvement, as quickly as two weeks, in corneal health and a reduction in symptoms.
~ 0
Million

people have signs and/or symptoms
of Dry Eye Disease in the United States1

~ 0
Million

people are diagnosed with
Dry Eye Disease in the United States1

~ 0
Billion

people have signs and/or symptoms
of Dry Eye Disease worldwide1

~ 0
Million

people are diagnosed with
Dry Eye Disease worldwide1

The Tear Film

Tear Film instability is one of the main causes of Ocular Surface Disease

Mucin Layer
Provides protection of the ocular surface against pathogens, physical damage and stabilizes the tear film, allowing it to spread evenly over the surface of the eye.
 

Produced by corneal epithelial cells and goblet cells on the conjunctiva.

Aqueous Layer

Provides nutrients, enzymes, growth factors, etc. to help nourish the cells of the ocular surface.

Produced by the lacrimal glands.

Lipid Layer

Stabilizes the tear film by complexing with tear proteins to prevent tear film collapse.

Produced by meibomian glands in the eyelids.

Tear Film Instability
Ocular Surface Disease
Corneal Disease

Low or no

Lacritin/Lacripep

Corneal Disease

With

Lacritin/Lacripep

Corneal Health

LEADERSHIP TEAM

Experience and expertise in ophthalmology

Anil C. Asrani

President / CEO

Gordon W. Laurie, PhD FARVO

Chief Scientific Officer / Co-founder

James N. Cook

Chief Development Officer

Colin M. Rolph

Chief Financial Officer

Marc G. Odrich, MD

Chief Medical Officer / Medical Director

Michelle A. Carpenter, JD, RAC

Chief Regulatory Officer

Board of Directors

Robert Dempsey

Executive Chair, Independent Director

Gordon W. Laurie, PhD FARVO

Chief Scientific Officer, Co-founder and Director

Robert Dempsey

Executive Chair, Independent Director

Anil C. Asrani

President, Chief Executive Officer, Director

Mark Logan

Co-founder and Director

Dr. Amir Shojaei, PharmD, PhD

Preferred A Director

James Ramey

Preferred B Director

Dr. Louis M. Alpern, MD, MPH, FACS, FICS

Independent Director

Jens Biertumpel

Independent Director

Medical Advisory Board

Dr. Kelly Nichols

Dean, School of Optometry, University of Alabama Birmingham

Dr. Deepinder Dhaliwal

Professor of Ophthalmology University of Pittsburgh School of Medicine

Dr. John Sheppard

Founder Virginia Eye Consultants

Dr. Nancy McNamara

Professor UC Berkeley School of Optometry

Strategic Advisory Board

Amir Shojaei

Strategic Advisory Board

First-in-human Clinical Trial

Goal: Test whether Lacripep restores health to eyes of patients with ocular surface disease associated with primary Sjögren’s Syndrome (NCT03226444).

Trial Sites: ~35 private and academic clinics in 17 different states.

Status: Enrollment complete.  Statistically significant improvement in both sign and symptom at two weeks.

Phase IIb Clinical Trial

Goal: Optimize Lacripep’s efficacy in patients with moderate/severe general dry eye.  

Trial Sites: ~10 – 12 private and academic clinics expected.

Status:  Clinical trial protocol design/development and fundraising.

If you are interested in participating in a clinical trial for Lacripep in Denver, CO, or St. Louis, MO, contact TearSolutions today!

TearSolutions, Inc.
315 Old Ivy Way, Suite 301
Charlottesville, Virginia 22903

TearSolutions CFO Colin Rolph:
crolph@tearsolutions.com

434-951-0444

GET IN TOUCH

anil-asrani-headshot

Anil C. Asrani

Mr. Asrani joined TearSolutions as President and CEO in 2020 after spending more than 9 years with Medtronic PLC, a medical device company where he held positions in marketing, investor relations, business development and strategy. Prior to joining Medtronic, Mr. Asrani lead sales and marketing for Devicix, a medical device design firm, and spent more than a decade performing academic medical research. Early in his career, Mr. Asrani worked in the UVA laboratory of Dr. Gordon Laurie, TearSolutions co-founder and current Chief Scientific Officer, and was an initial investor in TearSolutions.
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Gordon W. Laurie, PhD FARVO

Dr. Laurie co-founded TearSolutions with Mark Logan in 2013 and serves as Chief Scientific Officer. Dr. Laurie is a Professor of Cell Biology, Biomedical Engineering and Ophthalmology and a former Pinn Scholar at the University of Virginia. He is co-author of the Tear Film Subcommittee of the DEWS II Report, member of the founding Governing Council of the Tear Film and Ocular Surface Society, an Executive Editor of Experimental Eye Research, founder of UVA’s NIH sponsored Biotechnology Training Program (now in its 21st year) and past winner of the Virginia Biotechnology Association Educator of the Year award.
Dr. Laurie’s lab discovered and named ‘lacritin’ out of an unbiased biochemical screen begun in 1992 to address the biological basis of dry eye. Lacripep’ was then created by the Laurie lab as a synthetic peptide embodiment of all known lacritin activities.

James N. Cook

Mr. Cook has been working with TearSolutions since 2021 as Chief Development Officer following more than 30 years of experience developing eye care products. He has extensive experience in ophthalmic formulation development, process development, chemistry/analytical laboratory management, and quality control/assurance. Prior to joining TearSolutions, Mr. Cook was Head of R&D for Consumer Eye Health at Abbott Medical Optics (acquired by J&J Vision) responsible for product and process development of eye drops and contact lens care products. He additionally held leadership roles at Allergan Pharmaceuticals and ISTA Pharmaceuticals overseeing the development of contact lens care products and eye care therapeutics.
Mr. Cook is Principal Consultant at J.N.Cook Pharma and Med Dev Consulting, LLC. He has a B.S. in Chemistry and B.S in Biology from University of Calif., Irvine; M.S. in Chemistry from Cal State Fullerton and M.B.A from Pepperdine University.
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Colin M. Rolph

Colin has been working with startup / early stage companies for the past 20+ years.He is a serial, earlystage CFO and has led numerous companies through all aspects of early stage and growth stage development. Mr. Rolph is also an angel investor and manager of a venture investment fund that focuses on medical devices, biotechnology and IT investments. Mr. Rolph has a B.S. from the Rochester Institute of Technology.
marc-odrich-headshot

Marc G. Odrich, MD

Marc has been in both private and academic medical practice and is currently Associate Professor of Ophthalmology at the University of Virginia where he practices and teaches clinical ophthalmology specializing in Refractive Surgery and Ocular Surface Disease. He has had pivotal roles in the development and commercialization of the excimer laser and the femto laser as former Medical Director for Visx, Inc and currently consults for multiple companies in the areas of corneal and refractive surgery, presbyopia correction and dry eye disease. Marc has authored and run over 25 clinical trials from phase 1 through phase 4 (post market) for industry.
Marc is the Chief Medical Officer for TearSolutions, Inc. a Charlottesville, VA based start up that is in clinical trials with a new drug developed for Sjogrens and dry eye disease. In addition he is a consultant to and Board of Directors member for CXLO, Inc. (epi-on corneal crosslinking for keratoconus), a consultant and medical monitor for Johnson & Johnson’s refractive products, and a consultant to Presbyopia Therapies, LLC.
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Michelle A. Carpenter, JD, RAC

Ms. Carpenter is a senior management leader and regulatory advisor with more than 25 years of experience gaining global approvals for drugs and biologics for companies ranging from start-up to Fortune 500. She has extensive experience in ophthalmology, including multiple programs for dry eye disease (Santen, Otuska) in addition to a broad number of indications to treat anterior and posterior eye segment diseases. Ms. Carpenter has held numerous Senior/Vice President roles in Regulatory Affairs, Quality Affairs and Project Management and has worked at True North and Afferent Pharmaceuticals, Sanofi, Santen, and Merck. She also teaches Regulatory Affairs certification courses for the UC Santa Cruz Bioscience Program and has managed a successful consulting firm.

She earned her Juris Doctorate, with emphasis in Health Law and Ethics, from Golden Gate University and her Bachelor’s degree at University of California at Santa Barbara.

Robert Dempsey

Robert brings more than two decades of domestic and global leadership experience in the Ophthalmology space driving successful drug development in public and private sectors through efficient organizational structure and capital investments. His widespread experience in Ophthalmology stems from diverse leadership roles across commercial, business development, medical affairs, and venture-backed startups. Currently, Robert serves as the Chief Executive Officer at AsclepiX Therapeutics focused on advancing an integrin regulating peptide for posterior segment diseases and recently led a successful Series A-3 financing. He joined Asclepix in 2021, after serving as the Chief Executive Officer for TearClear where he accelerated the business and commercial strategies including a successful Series B financing and positive FDA engagements. Prior to that, he served as the Global Head of Ophthalmology at Shire, then Takeda, responsible for one of the top ten largest biopharma M&A deals in 2019, the divestiture of Xiidra® (lifitegrast ophthalmic solution) 5%, to Novartis in June 2019 for up to $5.3B.

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Gordon W. Laurie, PhD FARVO

Dr. Laurie co-founded TearSolutions with Mark Logan in 2013 and serves as Chief Scientific Officer. Dr. Laurie is a Professor of Cell Biology, Biomedical Engineering and Ophthalmology and a former Pinn Scholar at the University of Virginia. He is co-author of the Tear Film Subcommittee of the DEWS II Report, member of the founding Governing Council of the Tear Film and Ocular Surface Society, an Executive Editor of Experimental Eye Research, founder of UVA’s NIH sponsored Biotechnology Training Program (now in its 21st year) and past winner of the Virginia Biotechnology Association Educator of the Year award.
Dr. Laurie’s lab discovered and named ‘lacritin’ out of an unbiased biochemical screen begun in 1992 to address the biological basis of dry eye. Lacripep’ was then created by the Laurie lab as a synthetic peptide embodiment of all known lacritin activities.
anil-asrani-headshot

Anil C. Asrani

Mr. Asrani joined TearSolutions as President and CEO in 2020 after spending more than 9 years with Medtronic PLC, a medical device company where he held positions in marketing, investor relations, business development and strategy. Prior to joining Medtronic, Mr. Asrani lead sales and marketing for Devicix, a medical device design firm, and spent more than a decade performing academic medical research. Early in his career, Mr. Asrani worked in the UVA laboratory of Dr. Gordon Laurie, TearSolutions co-founder and current Chief Scientific Officer, and was an initial investor in TearSolutions.

Mark Logan

Mark B. Logan is the Co-founder and Director of the Company. Mr. Logan and Dr. Gordon Laurie co-founded the Company in 2013, and he served as the President and CEO of the Company from 2013 to 2016. Prior to his work with the Company, Mr. Logan was the President, CEO and Chairman of VISX, Inc. (now a division of Johnson & Johnson). VISX invented, developed, obtained FDA approval and commercialized the procedure known as LASIK. Prior to joining VISX, he was Senior VP, COO and served on the Board of Directors of Bausch & Lomb.

Mr. Logan has a B.A. degree from Hiram College and did graduate studies at New York University (Woodrow Wilson Fellow) and Harvard University (PMD).

Dr. Amir Shojaei

Dr. Shojaei brings over two and a half decades of experience in clinical pharmaceutical development and is currently the Chief Scientific Officer and Executive Vice President of Clinical Development at AsclepiX Therapeutics. Prior to this, he served as the CEO of TherOptix and as the Chief Development Officer for TearClear. Dr. Shojaei has also held the position of Therapeutic Area Head of Ophthalmology for Shire/Takeda, where he oversaw all aspects of the clinical-stage ophthalmic pipeline. Notably, he led the development and approval of Xiidra® in the U.S. and in multiple international markets, including Canada, Mexico, Australia, Switzerland, South Korea, and the Gulf countries.
James Ramey

James Ramey

James Ramey is a Managing Director and Fund Manager at Middleland Capital where he manages VTC Ventures. VTC Ventures invests in high growth Seed, Series A, and Series B-stage healthcare companies across the country, the Commonwealth of Virginia, and within the broader Virginia Tech, Carilion, and Roanoke / Blacksburg ecosystem. Prior to joining Middleland Capital, Mr. Ramey was a Vice President at Tyton Partners, a leading ed-tech investment banking firm located in the greater New York City area. James’ unique background, which includes practicing law, investment banking, and prior venture capital experience, provides a holistic and multi-faceted approach to venture capital investing. In addition to Tear Solutions, VTC Ventures is an investor in multiple clinical and pre-clinical stage pharmaceutical, device, and diagnostic startups.

Dr. Louis M. Alpern

Dr. Alpern has more than four decades of private practice and clinical trialing experience in ophthalmology, having served as a Principal Investigator in over 100 ophthalmology clinical trials. He received his Doctor of Medicine from Harvard Medical School and his Master of Public Health from the Harvard School of Public Health.
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Jens Biertumpel

Jens Biertumpel is Responsible Officer and Head of the Investment Committee of Helios Asset Management, and he was Founder, Managing Director and Portfolio Manager of Lightstream Capital. Prior to 2015 Mr. Biertumpel was Founder, Vice Chairman and Managing Director of Mont Blanc Capital Management AG. He currently sits on the Board of Directors of Pascal Biosciences, Medcert Solutions Ltd., and Bight Petroleum, Inc.
Mr. Biertumpel has a B.A. degree from Simon Fraser University.

Dr. Kelly Nichols

Dr. Kelly Nichols, OD, MPH, PhD, FAAO is the Dean of the University of Alabama at Birmingham School of Optometry. Prior to that appointment, Dr. Nichols was a professor at the University of Houston, College of Optometry, where she co-founded and served as Executive Director for the Ocular Surface Institute, a translational research institute focused on bench-tobedside research on ocular surface conditions. Earlier, Dr. Nichols was faculty at the Ohio State University College of Optometry. She currently serves as a medical adviser to the Sjögren’s Syndrome Foundation and has served on the executive board for the Tear Film and Ocular Surface Society and on the DEWS, DEWS II, Contact Lens Discomfort, MGD and Lifestyle workshops, and is a founding member of Ocular Surface Society of Optometry. As a leading expert in dry eye disease, Dr. Nichols is or has been on the editorial boards of the journals Optometry and Vision Science, and The Ocular Surface, and is extensively published. Dr. Nichols received her Doctor of Optometry degree from the University of California at Berkeley, completed a residency in ocular disease at Omni Eye Specialists of Colorado, and earned her MPH in biostatistics and PhD in vision science at Ohio State University.
Deep Dhaliwal

Dr. Deepinder Dhaliwal

Dr. Deepinder K. Dhaliwal, MD, L.Ac is a professor of ophthalmology at the University of Pittsburgh School of Medicine, co-director of the cornea and external disease service, chief of refractive surgery, director and founder of the Center for Integrative Eye Care, and vice chair for communications and wellness at the UPMC Eye Center. She has been involved with several research trials in dry eye and is clinical co-director of the Corneal Regeneration Task Force in the department of ophthalmology. She serves as Vice President of the Cornea Society for industry relations and is on the executive committee of the International Society of Refractive Surgery (ISRS) of the American Academy of Ophthalmology and the Eye and Contact Lens Association. She has received numerous awards including the senior achievement award from the American Academy of Ophthalmology, and was selected to be on the Powerlist 2022 (which includes the top 100 most influential ophthalmologists in the world). Dr Dhaliwal received her combined bachelor’s and medical degree through the Honors Program in Medical Education at Northwestern University, completed her ophthalmology residency at the University of Pittsburgh Eye and Ear Institute, and her fellowship in cornea, external disease, and refractive surgery at the University of Utah.

Dr. John Sheppard

Dr. John Sheppard, MD is the Mid-Atlantic Medical Director of Eye Care Partners, former Board of Directors member of CVP Physicians, the senior and founding partner of Virginia Eye Consultants, and the COO of the translational pharmaceutical development company EyeRx Research, Inc. At Eastern Virginia Medical School, Dr Sheppard serves as Professor of Ophthalmology, Microbiology, and Molecular Biology; the research director for the Ophthalmology residency program; and the clinical director of the Thomas R. Lee Center for Ocular Pharmacology and has been a recipient of the Honor and Senior Honor Awards from the American Academy of Ophthalmology. Dr Sheppard received his bachelors, master’s and Doctor of Medicine degree in the 7 year Brown University Program in Medicine on a full US Navy Armed Forces Health Professions Scholarship. He completed a pediatrics internship at the University of Virginia and a residency at the Pittsburgh Eye & Ear Institute and a cornea, uveitis, immunology and international ophthalmology fellowship at the UCSF Proctor Research Foundation.

Dr. Nancy McNamara

Dr. Nancy McNamara, OD, PhD, MS is currently the Associate Dean for Academic Affairs at the University of California Berkeley (UCB), Herbert Wertheim School of Optometry and Vision Science. She received her Doctor of Optometry degree from the Michigan College of Optometry and completed a Cornea & Contact lens residency at UC Berkeley. Following
residency, Dr. McNamara earned her Ph.D. in Vision Science at UCB and embarked on a research career at the University of California, San Francisco (UCSF) where she studied the cellular and molecular mechanisms of ocular inflammation, infection, and dry eye disease. She returned to UCB to establish and co-direct the University Eye Center, Dry Eye Clinic. Dr. McNamara continues an active translational research program that includes both basic science studies to define the mechanisms underlying dry eye disease development at UCSF and clinical studies to test innovative new therapies for clinical care at UCB. She established and currently directs UCB’s Sjogren’s Clinic, a multidisciplinary care center for Sjogren’s patients, and recently joined UCSF and several top research institutions in the United States to form the Sjogren’s Team for Accelerating Medicines partnerships.

Amir Shojaei

Dr. Amir Shojaei

The establishment of TearSolutions’ Strategic Advisory board was accomplished with the appointment of Dr. Amir Shojaei, PharmD, PhD. Amir has built a career in life sciences as a leader with over two and a half decades of drug development experience, and spent just under 20 years at Shire until it was acquired by Takeda in Jan 2019. At Shire, he helped create the ophthalmology franchise as the Global Therapeutic Area Head in Ophthalmology and was later able to successfully divest the key asset in that franchise, Xiidra®, to Novartis for $5.3 Billion. While at Shire, Amir oversaw all aspects of clinical stage ophthalmic pipeline assets. His team brought Xiidra® (lifitegrast) from development through to U.S. FDA filing and approval. Amir is currently the Chief Scientific Officer and EVP-Clinical Development at AsclepiX Therapeutics focused on developing novel and durable treatment for retinal diseases.