Enrollment begins in phase III blepharitis trial
Alameda, CA—Patient enrollment has begun in a phase III clinical trial of ISV-502 (AzaSite Plus, InSite Vision) and ISV-305 (DexaSite, InSite Vision) to evaluate the efficacy and safety of both product candidates simultaneously for the treatment of blepharitis. The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study will seek to enroll about 900 patients with moderate-to-severe blepharitis in a four-arm trial.
“The DOUBle study has the potential to make a significant contribution to improving patient care and demonstrates our strong commitment to make [ISV-502] and [ISV-305] available for the more than 34 million blepharitis sufferers in the United States who currently have no approved drug therapies available to them,” said Kamran Hosseini, MD, PhD, vice president and chief medical officer of InSite Vision.
ISV-502 combines the corticosteroid dexamethasone 0.1% with the antibiotic azithromycin 1% in the company’s proprietary drug delivery platform (DuraSite), and ISV-305 combines dexamethasone 0.1% with the delivery platform.
The company has created two proprietary tools—an investigator scoring system (BleSSSED, or Blepharitis Signs & Symptoms Scoring for Evaluating Disease) and a patient quality-of-life survey (BleQOLITY, or Blepharitis Quality Of Life In TherapY)—to measure disease severity and aid in monitoring treatment response.
Patients with moderate-to-severe blepharitis will be randomly assigned to one of four study arms to receive treatment with ISV-502, ISV-305, azithromycin 1% ophthalmic solution (AzaSite), or the delivery vehicle twice daily for a period of 14 days. ISV-502 will be evaluated against azithromycin 1% for the primary endpoint of resolution of the clinical signs and symptoms of blepharitis, and against ISV-305 to compare the length of time to recurrence or exacerbation of symptoms following the treatment period. The efficacy and safety of ISV-305 will be measured against the delivery vehicle for the primary endpoint of resolution of clinical signs and symptoms of blepharitis at the end of the dosing period.
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