An anti inflammatory product developed by InSite Vision Inc. to reduce pain and inflammation associated with ocular surgery, will undergo a phase 1/2 clinical trial.
An anti-inflammatory product developed by InSite Vision Inc. to reduce pain and inflammation associated with ocular surgery, will undergo a phase 1/2 clinical trial.
The product, ISV-303, combines a low dose of bromfenac, a non-steroidal anti-inflammatory drug, with InSite Vision’s DuraSite technology.
The clinical trial will be randomized and placebo-controlled and is designed to evaluate the safety, efficacy, and pharmacokinetics of ISV-303 administered once-daily. The study will enroll approximately 160 patients and will be divided into four arms: one receiving ISV-303 once daily, one receiving ISV-303 twice-daily, vehicle, and one receiving an approved topical anti-inflammatory agent twice daily.
The two-week drug therapy will begin after an ocular surgery procedure. The patients will be assessed for pain and overall satisfaction. Along with patient responses, the treating physicians will be asked for an objective assessment from utilizing ophthalmic tests and diagnostics. Results from the study will provide guidance on the design of a phase 3 clinical program.
“Bromfenac and similar topical NSAIDs are regularly used to manage ocular inflammation and pain following cataract surgeries and other procedures; however, we believe there is a significant opportunity to improve on existing products,” said Kamran Hosseini, MD, PhD, vice president, Clinical Affairs and Chief Medical Officer of InSite Vision, in a press release. “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. We expect to report initial data from this Phase 1/2 clinical study in early 2011 and these results will guide the design of Phase 3 studies, which could begin as early as the second half of 2011.”