Sjogren’s Syndrome patients are experiencing a growing number of options for treating dry eyes. Restasis (Ciclosporin) was the first, and a treatment with which I’ve found some success. Xiidra (Lifitegrast) was approved just last year, and while it is an eye drop like Restasis, it uses a different mechanism of action. As a result, I’m actually looking into getting a prescription to try it out to see if I can get additional benefits. Autologuous serum eye drops, made from a patient’s own blood, are one more option with which patents have seen success, though I have not personally tried them. Still, I prefer to have as many options as possible, as different patients react differently to medications.
A new clinical trial recently appeared in my feed, this time for an eye drop called Lamelleye. Because it is so new (the trial isn’t even recruiting yet), there is little information available on Lamelleye. Still, their corporate website does have some pages describing the treatment. Though there is not a lot of detail, it appears that Lamelleye contains a number of lips that naturally occur in our tear film. The trial is small (24 SS patients) and short (~7 months) and doesn’t not yet have a phase label, so I cannot be sure if it is a phase 1 or phase 2 trial. While it seems a bit small for a phase 2 trial, it is possible that eye drops don’t undergo the same scrutiny as something like a biologic drug. We will have to wait until they update the trial listing with more information.
Lacripep, produced by TearSolutions, is a product that I noticed earlier this year. Rather than listing on clinicaltrials.gov, the trial information is listed on their own fairly simple website. That being said, there are 27 different sites in the United states, so they are clearly taking the trial seriously. As a Phase 1/2 trial, they may not be listing on clinicaltrials.gov because it is still early (many phase 1 trials are never listed). As for the product itself:
The cofounder discovered ‘lacritin’, a tear protein deficient in dry eye and yet vital for normal eye tearing. Preclinical studies reveal that a single topical dose of lacritin naturally promotes basal tearing without irritation that lasts for hours. After multiple daily doses, elevated natural basal tearing is sustained one week later. Lacritin is also protective against inflammatory cytokines. Corneal staining is reduced to background and lacrimal gland inflammation is diminished. No other tear protein, nor dry eye drug, displays these properties.
Like Lamelleye, the product is so new that little information is available outside of the TearSolutions webpage, but it definitely appears that the product is moving forward.
Unfortunately, with both products in early phase trials, it could be many years before these products reach patients. Still, it is always good to have a healthy pipeline of treatments for the growing number of Sjogren’s Syndrome patients in the world.