InSite Vision Initiates Confirmatory Phase 3 Clinical Study of BromSite ™ for the Reduction of Inflammation and Pain after Cataract Surgery
ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has begun in the confirmatory Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of inflammation and pain after cataract surgery. This study will seek to enroll approximately 240 patients undergoing cataract surgery in a two-arm trial designed to evaluate the efficacy and safety of BromSite against the DuraSite vehicle alone. BromSite combines a low dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision's DuraSite drug delivery technology.
"Our BromSite clinical program has been advancing rapidly and we expect that to continue with this Phase 3 trial, which is identical in design to our prior successful Phase 3 study. In our first Phase 3 study, all patients completed the trial in less than six months and we were able to release top-line results in less than eight months, start to finish," said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical Officer of InSite Vision. "We anticipate top-line results from this Phase 3 study will be available in late 2013 or early 2014. Assuming positive results, we plan to file a New Drug Application with the FDA in 2014."
The first BromSite Phase 3 clinical trial enrolled 268 patients undergoing cataract surgery. On March 18, 2013, InSite announced that the primary endpoint of reduction of inflammation after surgery had achieved statistically significant superiority compared to vehicle (p<0.001). A secondary endpoint, reduction of pain, had also achieved statistically significant superiority to vehicle (p<0.001).
About the BromSite Phase 3 Studies
The BromSite Phase 3 clinical studies are two-arm, double-blind, placebo-controlled clinical trials where the placebo arm is the DuraSite vehicle. In the second, confirmatory Phase 3 BromSite study, patients undergoing cataract surgery at 15 separate sites will be 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 is the reduction of inflammation after surgery with a secondary endpoint of reduction of pain. Pharm-Olam International will again serve as the contract research organization managing the BromSite study on behalf of InSite Vision.
The design of the two Phase 3 clinical trials has been discussed with both the U.S. Food and Drug Administration (FDA) and two European country regulators. The design of the confirmatory Phase 3 study for BromSite reflects the full input from both the European regulators and the FDA.
About Cataract Surgery
Cataract surgery is the most frequently performed ocular surgery in the United States with more than three million procedures annually. Both before and after surgery, anti-inflammatory eye drops are prescribed to reduce pain and inflammation. 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 in ocular surgery that can lead to blindness. Most physicians believe that the higher penetration of bromfenac into the ocular tissues may reduce the risk of CME. InSite intends to do additional clinical studies post-approval in pursuit of adding prevention of CME to the BromSite label.
About BromSite ™
BromSite™ (ISV-303) is a low-dose (0.075%) bromfenac ophthalmic solution formulated in DuraSite and is being evaluated for the treatment of inflammation and ocular pain in the post-cataract surgery setting. In a Phase 1/2 study of 169 patients undergoing cataract surgery, once-daily and twice-daily doses of BromSite were compared against the DuraSite vehicle alone. Once-daily and twice-daily BromSite demonstrated superiority to vehicle (53.3% versus 19.0%, p=0.0016 and 52.5% versus 19.0%, p=0.0024, respectively) in reducing pain and inflammation. InSite reported results from the Phase 1/2 clinical study in March 2011. In a Phase 2 clinical study evaluating pharmacokinetics, BromSite achieved more than twice the eye tissue penetration than Bromday™ (bromfenac ophthalmic solution) 0.09% marketed by Bausch + Lomb. Results from the Phase 2 clinical trial comparing BromSite to Bromday were released in October 2011.
About InSite Vision
InSite Vision is advancing new ophthalmologic 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 inflammation, and BromSite™ for pain and inflammation associated with ocular surgery. For further information on InSite Vision, please visit www.insitevision.com.
This news release contains certain statements of a forward-looking nature relating to future events, including the expected timing of reporting the results of the BromSite Phase 3 trials, intentions to file a New Drug Application with the FDA, timing and possible results for InSite Vision's planned second Phase 3 trial for BromSite, the expected benefits of BromSite, future potential indications for and uses of BromSite, InSite Vision's plans with respect to DuraSite 2 and InSite Vision's intent to perform studies in pursuit of adding CME prevention to the BromSite label. Such statements entail a number of risks and uncertainties, including but not limited to: that InSite Vision's Phase 3 clinical trials may not meet their respective clinical endpoints or otherwise may not meet the objectives and requirements of the trials; that it may take longer than expected to announce the results of such trials, InSite Vision's ability to obtain FDA approval of BromSite and the timing thereof; InSite's reliance on third parties for the commercialization of its products; the ability of InSite Vision to enter into and maintain future corporate collaborations for its product candidates; InSite Vision's ability to expand its product platform, including BromSite, to include additional indications; InSite Vision's ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; InSite Vision'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 of the U.S. Patent and Trademark Office regarding same; InSite's ability to expand its product candidates and advance them; InSite's ability to effectively and on a timely basis enroll patients into its clinical trials, efficiently acquire materials necessary for its clinical trials and complete such clinical trials in a timely manner; 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 and other filings with the Securities and Exchange Commission. Any forward-looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change and readers should not place undue reliance on any such forward-looking statements. 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® and DuraSite® 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, 510-747-1220
Chief Financial Officer
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