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Amino acid peptide improves signs, symptoms in severe dry eye
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Patients with chronic graft-vs.-host disease who were treated with thymosin β4 eye drops (RGN-259, 0.1%) experienced statistically significant improvements in signs and symptoms, according to a study published in Cornea.
Sosne and colleagues conducted a randomized, double-masked, placebo-controlled phase 2 clinical trial at two U.S. sites. Researchers treated nine men and women older than 18 years with severe dry eye with either Tβ4, a naturally occurring 43 amino acid peptide found in high concentrations in most tissues and cells, or placebo six times a day. The 56-day trial included a 28-day follow-up.
The primary outcome measure was safety, which was evaluated by taking intraocular pressure and completing an ophthalmologic evaluation, including funduscopy, on days 1, 14, 28 and 56, they reported. The secondary outcome measures included vision, ocular discomfort, ocular surface irregularity, corneal and conjunctival staining, tear film break-up time, Ocular Protection Index, Schirmer’s test, Ocular Surface Disease Index and use of artificial tears.
“Statistically significant differences in both symptom and sign assessments were seen at various time points throughout the study,” the researchers reported. “Of particular note at day 56, the RGN-259–treated group (12 eyes) had a 35.1% reduction of ocular discomfort compared with vehicle control (six eyes) (P = 0.0141) and 59.1% reduction of total corneal fluorescein staining compared with vehicle control (P = 0.0108). Other improvements seen in the RGN-259–treated patients included tear film breakup time and increased tear volume production.”
The researchers concluded that the drops were “safe and well tolerated and met key efficacy objectives with statistically significant symptom and sign improvements, compared with vehicle control, at various time intervals, including 28-days posttreatment.
“In summary, Tβ4 is an effective treatment for dry eye in humans,” they added. “It improves the signs and symptoms in patients with severe dry eyes. It is relatively fast and long acting compared with other treatments in current use. Future trials will need to include a larger cohort of patients and test additional doses for efficacy.” – by Nancy Hemphill, ELS, FAAO
Disclosures: Sosne is on the medical advisory board of RegeneRx Biopharmaceuticals Inc. and occasionally provides intellectual advice. This company is developing RGN-259 for clinical treatment of wounds, including dry eye. The remaining authors have no relevant financial disclosures.
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