InSite Vision launches phase 1/2 trial of ocular anti-inflammatory candidate

ALAMEDA, Calif. — InSite Vision has launched a phase 1/2 clinical trial of a topical anti-inflammatory product for reducing the pain and inflammation linked with ocular surgery, the company announced.

The randomized, placebo-controlled trial will assess the safety, efficacy and pharmacokinetics of ISV-303, a formulation of a low concentration of bromfenac and the company's DuraSite drug delivery vehicle, in approximately 160 patients who will be split into four study groups. Specifically, patients will either receive ISV-303 administered once daily, ISV-303 administered twice daily, vehicle or an approved topical anti-inflammatory agent administered twice daily, according to a press release from the company.

All patients will receive drug therapy for 2 weeks following an ocular surgery procedure and will be followed for an additional 2 weeks. Patient-reported pain and overall satisfaction assessments will be pooled with objective ophthalmic assessments to provide the investigators with guidance on the design of a phase 3 clinical program for the compound, the release said.

"Leveraging our proven DuraSite technology to extend the duration of drug delivery to the eye, ISV-303 has the potential to offer important advantages in relieving pain and discomfort, as well as improving dosing convenience," Kamran Hosseini, MD, PhD, vice president of clinical affairs and chief medical officer for InSite Vision, said in the release.

The company plans to report preliminary data from the phase 1/2 trial early next year.