Inspire

• 
• 
• 
• 
• 
• 

• • History
  • Leadership
  • Business Development
  • Community
  • Careers
  • Contact
  • Overview
  • AZASITE^®
  • ELESTAT^®
  • Pipeline
  • Research
  • Publications
  • Analyst Coverage
  • Contact
  • Corporate Governance
  • Events & Presentations
  • News
  • SEC Filings

PROLACRIA^TM (diquafosol tetrasodium ophthalmic solution 2%) for dry eye - Phase 3; Approvable

Phase 1 Trials

Diquafosol was shown to be well tolerated in Phase 1 clinical trials.
Phase 1 data presentations and peer-reviewed publications

Phase 2 Trials

Trial 03-103
The Phase 2 trial, trial 103, was a 4-week environmental trial conducted in 158 patients. In this trial, diquafosol demonstrated statistically significant differences from placebo for mean corneal staining and mean conjunctival staining. The safety profile was comparable to placebo.
Press Release on Trial 103 results
Phase 2 data presentations and peer-reviewed publications

Phase 3 Trials

Trial 03-104
Trial 104 was a 3-month environmental trial with a 9-month safety extension conducted in 558 patients. In this trial, diquafosol did not demonstrate statistically significant differences from placebo for mean corneal staining at the primary timepoint. However, the trial did demonstrate statistically significant differences from placebo for mean corneal staining at 6 weeks using the secondary statistical analysis. The safety profile was comparable to placebo.
Press Release on Trial 104 results

Trial 03-105
Trial 105 was a 6-month environmental trial conducted in 527 patients. In this trial, diquafosol demonstrated highly statistically significant differences from placebo for mean corneal staining and mean conjunctival staining at multiple timepoints throughout the trial, and also showed strong trends in dry eye symptoms. The safety profile was comparable to placebo.
Press Release on Trial 105 results

Trial 03-108
Trial 108 was a 4-week trial conducted in 222 patients. The trial had an environmental component similar to the other Phase 2 and 3 trials, and a "chamber" component during which patients were exposed to a warm, dry environment to exacerbate their dry eye condition. In the environmental analysis, diquafosol demonstrated statistically significant differences from placebo for ocular staining (the incidence of complete reduction of staining on the cornea and some of the conjunctiva) at multiple timepoints throughout the trial. In the "chamber" portion of the trial, diquafosol did not demonstrate statistically significant improvement in ocular staining or discomfort. The safety profile was comparable to placebo.
Press Release on Trial 108 results

Trial 03-109
Trial 109 was a 6-week environmental trial conducted in 640 patients. In this trial, diquafosol failed to demonstrate statistically significant differences from placebo for the primary endpoint of the incidence of corneal clearing (complete reduction of corneal staining). Improvement compared to placebo was achieved for a number of secondary endpoints, including mean corneal staining, mean conjunctival staining and conjunctival clearing (complete reduction of conjunctival staining). The most common ocular adverse event, burning/stinging on instillation, occurred more frequently on diquafosol than on placebo, but the incidence was less than 5%.
Press Release on Trial 109 results
Phase 3 data presentations and peer-reviewed publications

Pipeline Links