Claimed effect · TB-500

Does TB-500 help with dry eye disease?

B
Grade B — probable, not settled2 phase 3 RCTs · effect size: small
Short answerProbable, not settled. Human data exist (2 phase 3 RCTs) and mostly agree, showing a small effect — but too few, too small, or not yet peer-reviewed for a firm answer. ARISE-1 and ARISE-2 tested a pharmaceutical eye drop. Improvements on some ocular-surface measures; primary endpoints not consistently met, and no approval followed.

What the studies show

ARISE-1 and ARISE-2 tested a pharmaceutical eye drop. Improvements on some ocular-surface measures; primary endpoints not consistently met, and no approval followed.

Human trials exist and mostly agree, but there are too few of them, they are too small, or one big one is still reading out. Expect the grade to move.

  1. 1
    RegeneRx. RGN-259 (thymosin beta-4 ophthalmic) ARISE-1 and ARISE-2 phase 3 trials in dry eye disease.Phase 3 programme; mixed endpoint results, no approvalThe only phase 3 human data for the parent molecule.

In context

TB-500 is a synthetic fragment of thymosin beta-4, a protein involved in cell migration and wound repair. Full-length thymosin beta-4 has been through phase 3 trials — as an eye drop for dry eye disease, with mixed results and no approval. The injected use people buy it for, for tendon and muscle injury, has never been tested in a completed human trial. It is banned in sport and not approved anywhere.

TB-500 is not approved. Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is TB-500 proven to help with dry eye disease?
Not yet settled. 2 phase 3 RCTs — LYO grades it B, meaning probable but liable to change as trials read out.
What studies are behind the grade?
ARISE-1 and ARISE-2 tested a pharmaceutical eye drop. Improvements on some ocular-surface measures; primary endpoints not consistently met, and no approval followed.
Is TB-500 approved for this?
No. TB-500 is not approved; it is not an approved medicine for any indication in the jurisdictions LYO covers.

Other outcomes for TB-500

Reviewed 2 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →