By Business Wirevia The Motley Fool
Filed under: Investing
InSite Vision Announces Positive Phase 3 Results for BromSite ™ (ISV-303) for the Reduction of Inflammation and Pain after Cataract Surgery
BromSite Demonstrates Statistical Significance Over Vehicle
ALAMEDA, Calif.–(BUSINESS WIRE)– InSite Vision Incorporated (OTCBB:INSV) today announced top-line results from its recently completed Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of inflammation and pain after cataract surgery. BromSite achieved statistically significant superiority compared to vehicle in alleviating ocular pain and inflammation among patients following cataract surgery. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite® drug delivery technology.
“The results of our Phase 3 clinical study verify the efficacy of BromSite in providing relief of pain and inflammation after cataract surgery at a lower drug concentration than the current market leader and reinforce our earlier clinical findings,” said Kamran Hosseini, M.D., Ph.D., Chief Medical Officer of InSite Vision. “We plan to rapidly initiate the second Phase 3 trial of BromSite in order to be prepared to file for regulatory approvals in both the United States and Europe as soon as possible after the completion of that trial.”
The BromSite Phase 3 clinical trial enrolled 268 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. Patients were randomized and then dosed twice-a-day beginning the day before surgery and continuing the day of surgery and for 14 days post-surgery. The primary study endpoint was the reduction of inflammation after surgery and BromSite achieved statistically significant superiority compared to vehicle (p<0.001). A secondary endpoint was reduction in pain and BromSite achieved statistically significant superiority compared to vehicle (p<0.001). BromSite was well tolerated, with no safety concerns or drug-related serious adverse events reported. Pharm-Olam International served as the contract research organization managing the BromSite study on behalf of InSite Vision.
Cataract surgery is the most frequently performed ocular surgery in the United States, with more than three million procedures annually. Typically, anti-inflammatory eye drops are prescribed to reduce pain and inflammation both before and after surgery. Anti-inflammatory eye drops are also administered as prophylaxis against cystoid macular edema, or CME. CME is a relatively rare, but extremely serious, adverse event that can result from ocular surgery and lead to blindness. Many physicians believe that a higher penetration of bromfenac into the ocular tissues may reduce the risk of CME. In a Phase 2 clinical study evaluating pharmacokinetics, BromSite achieved more than twice the eye tissue penetration of Bromday™ (bromfenac …read more
Source: FULL ARTICLE at DailyFinance
