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
ALAMEDA, Calif. – March 18, 2013 – 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 ophthalmic solution) 0.09% marketed by Bausch + Lomb. The results from this Phase 2 clinical trial comparing BromSite to Bromday were released in October 2011. InSite intends to do additional clinical studies post-approval, with the goal of adding prevention of CME to the BromSite label.
This is the first of two Phase 3 clinical studies in support of BromSite’s regulatory submissions. The Statistical Analysis Plan for the second Phase 3 study for BromSite will be finalized after receipt of full input from both the U.S. Food and Drug Administration and European regulatory authorities. InSite plans to present results from the BromSite Phase 3 clinical study at an upcoming scientific meeting.
About DuraSite ® and DuraSite 2 ® While eye drops are a proven delivery mechanism for numerous ocular drugs, efficacy of these agents is impeded by tears and blinking, which rinse the drug from the surface of the eye and limit retention and absorption. InSite's DuraSite and DuraSite 2 platforms are sustained delivery technologies using a synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. DuraSite and DuraSite 2 enable topical delivery of a solution, gel or suspension and can be customized to deliver a wide variety of potential drug candidates. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite ® and Besivance ® . InSite Vision is currently advancing a portfolio of novel preclinical- to clinical-stage ophthalmic product candidates based on the DuraSite platform and anticipates advancing future ophthalmic product candidates using the DuraSite 2 platform.
About InSite Vision InSite Vision is advancing new ophthalmic products for unmet eye care needs based on its innovative DuraSite ® platform technologies. The DuraSite and DuraSite 2 ® drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing the frequency of treatment and improving the efficacy of topical drugs. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections: AzaSite ® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck; and Besivance ® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus ™ and DexaSite ™ for the treatment of eye infections, and BromSite ™ for pain and inflammation associated with ocular surgery. For further information on InSite Vision, please visit www.insitevision.com.
Forward-looking Statements This news release contains certain statements of a forward-looking nature relating to future events, including the expected timing of the initiation of a second BromSite Phase 3 trial, the timing of filing for regulatory approvals for BromSite in the U.S. and Europe, the expected benefits of BromSite relative to competitive products, future potential indications for BromSite, including cystoid macular edema and plans for studies related thereto, InSite’s plans to present the results of the first BromSite Phase 3 study at a future scientific meeting, and InSite’s plans to advance future ophthalmic product candidates using DuraSite 2. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control and could materially affect actual results. Risks and uncertainties that could materially affect our actual results include but are not limited to: the results of future clinical trials and the timing thereof, InSite’s ability to obtain regulatory approval of BromSite from U.S. and European authorities and the timing thereof; InSite's reliance on third parties for the conduct of clinical trials and the commercialization of its products; the ability of InSite to enter into corporate collaborations for its product candidates, including BromSite; InSite's ability to expand its product platform, including BromSite, to include additional indications; InSite's ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; InSite's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. Reference is made to the discussion of these and other risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors" and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.
# # # AzaSite ® , DuraSite ® and DuraSite 2 ® are registered trademarks of InSite Vision Incorporated. AzaSite Plus ™ , BromSite ™ and DexaSite ™ are trademarks of InSite Vision Incorporated. BESIVANCE ® and Bromday™ are registered trademarks of Bausch + Lomb Incorporated.
Louis Drapeau, Chief Financial Officer
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Karen L. Bergman
Posted: March 2013