Thymosin Beta 4 Eye Drops Significantly Improve Signs and Symptoms of Severe Dry Eye

My patients are very smart and educated. Many have told me of their frustration in finding eye surgeons who take dry eyes symptoms and eye pain seriously and knows about all the treatment option to help them with their symptoms.

The focus for ophthalmologists, at least, has long been eye surgery which takes years to master. In residency, the most I learned about dry eye was related to eyelid/eye anatomy, the term blepharitis which was thought only to be do to Staph aureus (the word Demodex was never mentioned), and the use of artificial tears (Restasis was not mentioned; meibography was not even an idea yet in people’s minds that I knew of).

Fast forward 20 years, many of my patients have done a great deal of research to educate themselves and the doctors who treat them. The area of dry eye research and treatments has sky-rocketed to the point that it is hard for the average surgeon to keep track of all options, even if they read key ophthalmology journals, like I do.

Thymosin Beta 4 is a perfect example. This paper was published in 2013, 2015, & 2018 but phase 4 trials are only beginning on this potential treatment. Will it pass FDA criteria: we are waiting to find out.

SLC

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6043477/

https://iovs.arvojournals.org/article.aspx?articleid=2423767

and

ARVO Annual Meeting Abstract | June 2013

Abstract

Purpose: The purpose of this study was to evaluate the safety and efficacy of thymosin beta 4 (Tβ4) eye drops as a novel therapy for severe dry eye disease (including Graft vs Host Disease) in a double-masked, vehicle-controlled, physician-sponsored Phase 2 clinical trial. The study’s hypothesis is that Tβ4, in its role as a modulator of corneal surface healing and inflammation, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface.

Methods: Nine patients with severe dry eye (18 eyes) were treated with Tβ4 drops (0.1%) or vehicle control six times daily over a period of 28 days. They were evaluated upon entering the study after a two week washout period as follows: Study Day 1 (randomization and first day of treatment), 7, 14, 21, 28 (End of Treatment), and 56 (follow-up). Dry eye sign and symptom assessments, such as ocular discomfort (using the OSDI questionnaire) and corneal fluorescein staining (using the NEI workshop grading system), were evaluated at various time points throughout the study.

Results: Statistically significant differences in sign and symptom assessments, such as ocular discomfort and corneal fluorescein staining, were seen at various time points throughout the study. Of particular note at Day 56, the follow-up period, were the differences between Tβ4 and vehicle control. The Tβ4-treated group (12 eyes) had a 35.1% reduction of ocular discomfort compared to vehicle control (6 eyes) (p=0.0141), and a 59.1% reduction of total corneal fluorescein staining compared to vehicle control (p=0.0108). Other improvements seen in the Tβ4-treated patients included tear film breakup time and increased tear volume production.

Conclusions: Tβ4 eye drops were found to be safe and well-tolerated and met key efficacy objectives with statistically significant sign and symptom improvements, compared to vehicle control, at various time intervals, including 28 days post-treatment. These positive results suggest that further clinical trials are warranted and should aim to assess Tβ4’s efficacy and optimal dosing regimens in the setting of severe dry eye disease.