TearSolutions has developed LacripepTM, a proprietary first-in-class peptide therapy
The quality of human tear film is critical for corneal epithelial and neuronal cells’ survival. Several tear proteins are deficient in different forms of Dry Eye, the most common eye disease. One, called Lacritin, is deficient in ALL forms of Dry Eye 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.
Dry Eye 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.
TearSolutions’ founder and Chief Scientific Officer, Dr. Gordon Laurie, discovered ‘Lacritin’, a naturally occurring tear protein that is selectively deficient in ALL forms of Dry Eye. 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 to eyes of dry eye animals, 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 Dry Eye 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.
people have signs and/or
symptoms
of Dry Eye Disease in the United States1
people are diagnosed
with
Dry Eye Disease in the United States1
people have signs and/or
symptoms
of Dry Eye Disease worldwide1
people are diagnosed
with
Dry Eye Disease worldwide1
Produced by corneal epithelial cells and goblet cells on the conjunctiva.
Provides nutrients, enzymes, growth factors, etc. to help nourish the cells of the ocular surface.
Produced by the lacrimal glands.
Stabilizes the tear film by complexing with tear proteins to prevent tear film collapse.
Produced by meibomian glands in the eyelids.
Goal: Test whether Lacripep restores health to eyes of patients with Primary Sjögren’s Syndrome dry eye (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.
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.
TearSolutions, Inc.
315 Old Ivy Way, Suite 301
Charlottesville, Virginia 22903
TearSolutions CFO Colin Rolph:
crolph@tearsolutions.com
1. Market Scope 2020 Dry Eye Products
Market Report
Mr. Logan and Dr. Gordon Laurie co-founded TearSolutions in 2013, and he served as the President and CEO of TearSolutions from 2013 to 2016. Prior to TearSolutions, 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.
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.
