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.
For more articles in this issue of Ophthalmology Times eReport, click here.
MORE ARTICLES IN THIS ISSUE
Retinal research will benefit from a multiyear financial pledge to the University of Illinois at Chicago (UIC) department of ophthalmology and visual sciences from Parent Petroleum Co., a partner with the nonprofit organization Hope for Vision.
The FDA has granted orphan drug designation to sirolimus (DE-109, Santen) for the treatment of chronic/refractory anterior non-infectious uveitis, non-infectious intermediate uveitis, non-infectious panuveitis, and non-infectious uveitis affecting the posterior segment of the eye.
The FDA has approved the recombinant fusion protein aflibercept (Eylea, also known as VEGF Trap-Eye, Regeneron Pharmaceuticals) for the treatment of patients with neovascular age-related macular degeneration (AMD).
Researchers in Israel have completed a clinical trial that successfully tested the use of gene therapy to restore sight to patients suffering from Leber's congenital amaurosis (LCA).
STAAR Surgical Co. has received CE mark approval for a single-piece toric IOL (nanoFLEX Toric Collamer Single Piece IOL). The IOL, which is designed for patients who have cataracts and astigmatism, was approved for correction of 1.0 D to 4.0 D of cylinder in 0.5-D steps.