A new dry eye drug that aims to stimulate tear production will advance to phase 1/2 clinical testing this month.
The new therapy is based on a molecule discovered by Dr. Gordon W. Laurie, a glycoprotein he named lacritin. Preclinical studies show that lacritin, naturally secreted by lacrimal gland acinar cells, stimulates basal tear secretion, restores homeostatic function to ocular surface cells and reduces inflammatory cell activity when applied topically.
Its advancement to clinical trials caps a 16-year research journey. Although the initial trial is focusing only on Sjögren’s, Dr. Laurie believes the agent has potential to benefit patients across the disease spectrum because lacritin deficiency is apparent in all forms of dry eye.
“I was struck by the fact that no one seemed to be addressing the biological basis of dry eye disease other than downstream inflammation,” Dr. Laurie said of his early motivations in an interview with Ophthalmology Times. “Trying to identify this natural tear stimulatory activity was like looking for a needle in a haystack,” he said. “The needle was the novel protein that we named lacritin.”
The essential role of lacritin in healthy tear production was confirmed when Laurie’s team found that tears from dry eye patients consistently lack the protein and that no other proteins could induce the same restorative properties.
The current treatment candidate is a synthetic lacritin fragment which is easier to manufacture than the full peptide, yet maintains the same mechanism as the parent molecule, Dr. Laurie said.
For the upcoming trial, researchers aim to enroll 201 patients with Sjögren’s syndrome, randomized into 3 groups to receive 1 of 2 doses of the lacritin agent or placebo, 3 times a day for 4 weeks.
Results from animal studies have demonstrated high safety with no dose-limiting toxicity, as well as prolonged stability in the tear film.
“Analogous to insulin treatment for diabetes, (lacritin) essentially represents a replacement therapy to correct an existing deficiency” said Dr. Laurie. “For that reason, we believe it holds exciting promise as a very safe and effective therapy.”