New technology leads successful clinical trial to treat dry eye

A team led by Hironmoy Das, Ph.D., of the TTUHSC Jerry H. Hodge School of Pharmacy recently completed a clinical trial using corneal epithelial stem cells to improve outcomes for patients with DED. Credit: TTUHSC

Several studies conducted over the past decade have concluded that dry eye (SED) affects up to 50% of the U.S. population, creating a liability for the nation’s health care system that is estimated to be over $ 50 billion per year. year. And although women and patients living with autoimmune disorders exhibit a propensity to develop DED, the disease appears in all ethnicities and demographics of the population as people age.

There are many treatments for DED currently available, including eye lubricants, topical antibiotics, topical corticosteroids, scleral contact lenses designed to sharpen vision and provide comfort to dry eyes, and many more. Despite this menu of DED treatment options, Hironmoy Das, Ph.D., professor of pharmaceutical sciences at the Texas Tech University Health Sciences Center (TTUHSC) Jerry H. Hodge School of Pharmacy, said clinicians and researchers continued to see a need to develop safer and more effective treatment options.

With this in mind, Das has developed a technology derived from corneal epithelial stem cells to improve outcomes for patients with DED. Corneal epithelial stem cells are located and obtained only from the limbus, which is the area of ​​the eye where the cornea and conjunctiva intersect. The results of their clinical trial, “Corneal Epithelial Stem Cell Supernatant in the Treatment of Severe Dry Eye Disease: A Pilot Study”, were published on July 16 in The Journal of Clinical Ophthalmology.

The research team also included Sloan W. Rush, MD, of the Panhandle Eye Group in Amarillo, Texas, who led the clinical trial, and Jennifer Chain, Ph.D., of the Oklahoma Blood Institute in Oklahoma City.

Other than a few treatments that require the use of invasive surgery or that employ biological material that is not specifically intended for the ocular surface, there are currently no studies in which a safe and impactful therapeutic biological agent for the SSO is reported. Das said this makes his team’s clinical study unique as it is for the first time exploring a novel patient-delivered topical application derived from human corneal epithelial stem cells for the treatment of severe DED in humans. Normally, stem cells are injected into a patient, but in this case, rather than injecting the stem cells, the Das team has made a product from the stem cells that is applied like eye drops.

“It’s very exciting because this is the first time that my research has led to a clinical trial,” Das said. “Laboratory researchers cannot do clinical trials, so we depend on clinicians like Dr. Rush.”

Since there were no Good Manufacturing Practices (GMP) facilities available in the Amarillo, Texas area at the time the study began, Das and Rush collaborated with the Oklahoma Blood Institute. GMP facilities adhere to a specific and detailed United States Food and Drug Administration (FDA) regulatory system designed to ensure that products are manufactured consistently and meet rigorous quality control standards.

As a GMP facility, the Oklahoma Blood Institute can isolate and grow human cells, such as stem cells, which can then be transplanted into humans or, in this case, used to derive a drug for topical application. The corneal epithelial stem cells used in the drug were obtained from donor tissue from an eye bank.

For the clinical trial, Rush identified 17 patients with severe DED, as determined by a score ≥14 on the Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire and a score ≥40 on the Surface Disease Index. eyepiece (OSDI). All of the patients in the clinical trial also had documented attempts to treat their DED using at least six and up to 14 different conventional therapies for dry eye.

“Nothing was helping them; they were in very serious condition,” Das said. “Some of them could only go out in the dark because their inflammation was so severe that the sunlight burned their eyes.”

During the clinical trial, each patient self-administered the Das team’s topical corneal epithelial stem cell product four times daily in both eyes for 12 weeks. At that time, patient-reported outcome measures were determined primarily through the SPEED questionnaire, OSDI score, and an analog visual score produced using the University of North Carolina Dry Eye Management Scale. .

Compared to each patient’s baseline scores, the 12-week results showed that the SPEED questionnaire scores improved by an average of 4.7 points, or 23%, and the OSDI scores, by an average of 10.9 points. , or 17.1%. In addition, analogue visual scores improved by an average of 1.1 points (14%).

None of the patients in the clinical trial reported any significant side effects or side effects, and although this is not allowed until the FDA approves the product, all have requested that its use be resumed. at the end of the 12 week trial.

Das said the success of the product in the clinical trial is likely because the product does two things simultaneously: it regenerates damaged eye tissue and reduces inflammation.

“Most patients with dry eye will benefit,” Das said. “Current dry eye drugs do not regenerate any of the damaged eye tissue. Stem cells have the power to regenerate tissue and can also reduce inflammation, which is often the source of eye pain.”

Das said the university has filed for patents in the United States and Europe and that the eye drops are currently undergoing third-party validation in a double-blind study to bring the product closer to the market. .

Corneal endothelial cells derived from stem cells represent a possible alternative to donor tissue in transplant surgeries

More information:
Sloan W Rush et al, Corneal epithelial stem cell supernatant in the treatment of severe dry eye: a pilot study, Clinical Ophthalmology (2021). DOI: 10.2147 / opth.s322079

Provided by Texas Tech University

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