BOSTON, Sept. 20, 2016 /PRNewswire-USNewswire/ -- Lubris BioPharma today announced positive results of a clinical trial that showed recombinant human lubricin demonstrated significant improvement in both signs and symptoms of dry eye disease compared to sodium hyaluronate (HA). Results are published in the September issue of The Ocular Surface.
In the manuscript entitled, "A Two-Week, Randomized, Double-masked Study to Evaluate Safety and Efficacy of Lubricin (150 μg/mL) Eye Drops Versus HA 0.18% Eye Drops (Vismed®) in Patients with Moderate Dry Eye Disease," researchers evaluated the use of recombinant human lubricin, an endogenous glycoprotein with anti-inflammatory, lubricating and anti-adhesive activity as a treatment for patients with dry eye disease.
Key highlights from the study include:
- Subjects receiving lubricin experienced greater than a 70% reduction in their symptoms from baseline;
- Lubricin demonstrated statistically significant improvements against HA in the following symptoms: foreign body sensation (p<.013), sticky feeling (p<.0432), blurred vision (p<.0013), and photophobia (p<.011) in at least one eye;
- Lubricin demonstrated statistically significant improvements against HA in the following objective signs of dry eye: corneal fluorescein staining (OD/OS: 43.8%, 50.0%, vs. 26.5%, 23.3%, p<.0398, p<.0232), TFBUT (p<.010), eyelid erythema (p<0.004), conjunctival erythema (p<.0013), and daily mean instillations (p<0.04), and;
- No treatment-related, adverse events occurred during the investigation.
"Patients with dry eye suffer from a wide variety of symptoms impairing both their vision and quality of life and current treatments provide only limited symptomatic relief. These clinical results are encouraging as lubricin reduced every measured symptom, and also improved multiple objective signs of the disease. I am unaware of any other treatment that has shown such a consistent and sizable therapeutic effect, particularly when compared against another active compound," said Edward Truitt, a co-author of the study and CEO of Lubris BioPharma. "We are looking forward to the next stage of clinical development."
rh-Lubricin is the recombinant form of Lubricin (PRG4), a large endogenous complex glycoprotein that binds to, and protects tissue surfaces from friction induced wear & damage. Lubricin is the most lubricating and anti-adhesive molecule in the human body and has natural anti-inflammatory properties as well. Originally identified in joints, lubricin is also found on the ocular surface and in numerous additional tissues throughout the human body.
About the Clinical Trial
The objective of this clinical trial (NCT02507934) was to assess the efficacy and safety of recombinant human lubricin as compared to a 0.18% sodium hyaluronate (HA) eye drop in subjects with moderate dry eye disease (DED). Methods: DEWS Grade 2-3 subjects were randomized to use lubricin (N=19, 51.9±11.8 years) or HA (N=20, 61.8±13.3 years). After a saline washout period, subjects administered BID therapy for 7 days, followed by instillation as needed for 7 days. Visual analog scale (VAS) including foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia were primary outcomes, with secondary endpoints of corneal fluorescein staining, Schirmer test, tear film breakup time (TFBUT), eyelid and conjunctival erythema and number of instillations compared at day 14.
ABSTRACT LINK: http://www.ncbi.nlm.nih.gov/pubmed/27614318
ARTICLE REFERENCE: The Ocular Surface. August 2016, ahead of print. DOI: http://dx.doi.org/10.1016/j.jtos.2016.08.004.
About Lubris BioPharma
Lµbris BioPharma is a biopharmaceutical company developing recombinant human lubricin for the treatment of dry eye, osteoarthritis and other age & inflammation-related conditions. Lubricin functions like biologic Teflon® – it is naturally produced throughout the human body protecting tissues and other surfaces from friction-related damage and wear. Supplementation with recombinant human lubricin is an innovative and exciting new approach to disease management. For more information please visit www.lubris.net.
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SOURCE Lubris BioPharma