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Phase 3 trial finds comparable efficacy with 5% diquafosol dosed 3 times daily

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According to a Phase 3 noninferiority trial, 5% diquafosol eye drops demonstrate comparable efficacy and tolerability to 3% diquafosol for dry eye disease with a reduced dosing schedule.

The double-blind, multicenter trial randomized 271 participants to 5% diquafosol (TJO-083) 3 times daily or 3% sodium diquafosol (Diquas-S) 6 times daily for 12 weeks.

Of the 268 participants included in the full analysis set, corneal fluorescein staining (CFS), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, and Schirmer test values improved significantly from baseline by week 4 and remained improved through week 12 in both groups.

No significant between-group differences were observed for CFS (P = 0.6548), TBUT, OSDI scores, or Schirmer test values. Blurred vision was reported more frequently with 5% diquafosol (P = 0.0022), while photophobia occurred more frequently with 3% diquafosol (P = 0.0323).

Reference

Lee HK, Kim TI, Song JS, et al. Three-Times-Daily 5% Diquafosol Versus Six-Times-Daily 3% Diquafosol for Dry Eye Disease: A Randomized, Double-Masked, Multicenter Phase 3 Noninferiority Trial. J Ocul Pharmacol Ther. 2026;10807683261496778. doi: 10.1177/10807683261496778. Epub ahead of print. PMID: 42968636.

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