Company Plans to File a New Drug Application (NDA) for Approval of BromSite in 2014 with the U.S. Food and Drug Administration (FDA)
December 18, 2013 08:30 AM Eastern Standard Time
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: INSV) today announced top-line results from its recently completed confirmatory Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of inflammation and pain after 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 confirmatory BromSite Phase 3 clinical trial enrolled 248 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. In this second pivotal trial, BromSite achieved statistically significant superiority compared to vehicle (p=0.01) in alleviating ocular inflammation (measured by the absence of cells in the anterior chamber of the eye) at Day 15 among patients following cataract surgery compared to the vehicle arm. BromSite also achieved statistically significant superiority compared to vehicle (p<0.001) for the secondary endpoint of post-surgical reduction in pain. BromSite also achieved a third endpoint of reduction in inflammatory flare (p<0.01) that was incorporated into the protocol based on feedback from European regulatory authorities. Results reported today from InSite's Phase 3 study of BromSite reflect a modified "intent-to-treat" population agreed upon with the U.S. Food and Drug Administration (FDA) after the trial was completed. Under the modified intent-to-treat protocol, fourteen patients enrolled in the study who did not undergo surgery and complete dosing past Day 1 have been excluded from the efficacy results and analysis. BromSite was well tolerated, with no safety concerns or drug-related serious adverse events reported. InSite management will review results from its Phase 3 clinical trials of BromSite in its planned January 9, 2014 Research and Development conference call and webcast.
"Our Phase 3 clinical study verifies the efficacy of BromSite in providing relief of inflammation and pain following cataract surgery. In consultation with the FDA on our BromSite Phase 3 program, we have modified the intent-to-treat population to include just data from those patients who underwent surgery, thereby more accurately gathering data that pertain to the post-surgical indication," said Kamran Hosseini, M.D., Ph.D., Chief Medical Officer of InSite Vision. "We believe we have an excellent working relationship with the FDA and have collaborated closely with the Agency to establish clear endpoints and study protocols for all of our clinical trials. We anticipate that the positive results from our two Phase 3 studies will provide a solid basis for our planned New Drug Application regulatory filing for BromSite in the second half of 2014. We look forward to a pre-NDA meeting with the FDA on January 13, 2014, to discuss the full results of our Phase 3 clinical trials of BromSite."
The results from the second, confirmatory study of BromSite are similar to those achieved in InSite Vision's first Phase 3 clinical evaluation of BromSite for the reduction of inflammation and pain following cataract surgery. BromSite achieved statistically significant improvements versus vehicle across the primary and secondary endpoints in InSite's first Phase 3 clinical trial enrolling 268 patients. As agreed upon in discussions with the FDA, the final efficacy analysis from the first Phase 3 clinical study will also utilize the modified intent-to-treat population to reflect only those patients who actually underwent cataract surgery, excluding a total of twelve patients who were enrolled in the trial but did not undergo surgery. Using the modified intent-to-treat population did not change the positive results of the first Phase 3 study. Based on the positive results from two Phase 3 clinical trials, InSite has scheduled a pre-NDA meeting with the FDA in January and plans to file the NDA for BromSite's regulatory approval during the second half of 2014. Similarly, InSite plans to seek regulatory approval for BromSite in Europe. Pharm-Olam International served as the contract research organization managing the BromSite Phase 3 clinical studies on behalf of InSite Vision. The company intends to present complete results from the BromSite Phase 3 clinical program at an upcoming scientific meeting.
InSite also intends to utilize the modified intent-to-treat protocol for any future clinical studies of its DuraSite-based compounds, such as DexaSite™ (dexamethasone 0.1% with DuraSite) in the post ocular surgical setting.
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, a subsidiary of Valeant Pharmaceuticals. 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.
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 Akorn Pharmaceuticals; and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb, a subsidiary of Valeant Pharmaceuticals. InSite Vision is also advancing AzaSite Plus™ and DexaSite™ for the treatment of eye infections through Phase 3 clinical studies. BromSite™ for inflammation and pain associated with ocular surgery has completed its Phase 3 study program, consisting of two Phase 3 trials, and the Company plans to file for regulatory approval in the U.S. in 2014. 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 timing of filing for regulatory approvals for BromSite in the U.S. and Europe, timing of a pre-NDA meeting with the FDA for BromSite 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; The FDA's continued acceptance of the modified intent-to-treat protocol with respect to the results of the second BromSite Phase 3 clinical trial; that InSite's pre-NDA meeting with the FDA on BromSite may be delayed or cancelled and the results 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, 510-747-1220
Chief Financial Officer
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