Tag Archives: Kamran Hosseini

Gholam A. Peyman, M.D., Joins InSite Vision's Scientific Advisory Board

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Gholam A. Peyman, M.D., Joins InSite Vision’s Scientific Advisory Board

Dr. Peyman is a Recipient of the National Medal of Technology and Innovation and the Inventor of Lasik Eye Surgery

ALAMEDA, Calif.–(BUSINESS WIRE)– InSite Vision Incorporated (OTCBB: INSV) today announced that Dr. Gholam A. Peyman has joined its Scientific Advisory Board (SAB) which helps to guide and shape the InSite Vision research programs in the development of novel ophthalmic medicines. Members of the SAB are leaders in ophthalmic research, treatment and clinical drug development and include Richard Lindstrom, M.D., Gary Foulks, M.D., Michael Lemp, M.D., and Kelly Nichols, O.D., M.P.H., Ph.D. Kamran Hosseini, M.D., Ph.D., InSite’s Chief Medical Officer, is the leader of the SAB and Brian Levy, O.D., a member of InSite’s Board of Directors participates in all SAB meetings.

“We are elated that Dr. Peyman has joined the InSite Vision Scientific Advisory Board and I look forward to his counsel as we advance our broad product development pipeline,” said Dr. Hosseini. “Our ability to attract world-class innovators to our SAB reflects the significant progress we are achieving in the development of ocular medicines.”

Dr. Peyman is currently a professor of Basic Medical Sciences at the University of Arizona, emeritus professor of Tulane University and a pioneer in vitreoretinal surgery, intraocular drug delivery, refractive surgery and the chorioretinal biopsy and intraocular tumors technique. He is the recipient of the nation’s highest honor for technology achievement, The National Medal of Technology and Innovation, awarded by the President of the United States to America’s leading innovators. He is an active retina surgeon who also is a prolific and successful inventor with 136 issued patents in a wide variety of devices, intraocular drug delivery, surgical techniques as well as new methods of diagnosis and treatment.

Dr. Peyman is most widely known as the inventor of Lasik eye surgery, a vision correction procedure that allows people to see clearly without glasses. His first Lasik U.S. patent was issued in 1989. In 2005, he was selected by more than thirty thousand ophthalmologists to become one of the thirteen living ophthalmologists inducted into the Hall of Fame of Ophthalmology.

Some of his past innovations include: evaluating the injection of antibiotics into the vitreous for the treatment of endophthalmitis (1971); development of eye-wall resection (1970) and endoresection of intraocular tumors (1985); performance of the first retinochoroidal biopsy (1975), endolaser (1980) and transplantation of retinal pigment epithelial cells (1989) for patients with age-related macular …read more
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InSite Vision Announces Positive Phase 3 Results for BromSite™ (ISV-303) for the Reduction of Inflam

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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