ALAMEDA, Calif., Oct 04, 2011 (BUSINESS WIRE) -- InSite Vision Incorporated (INSV) today announced positive top-line results from a Phase 2 pharmacokinetic (PK) clinical study comparing the tissue penetration profile of InSite Vision's BromSite (ISV-303) with ISTA Pharmaceuticals' Bromday (bromfenac ophthalmic solution) 0.09%. BromSite combines a lower dose (0.075%) of the non-steroidal anti-inflammatory drug (NSAID) bromfenac with InSite Vision's DuraSite drug delivery technology and is intended to reduce the pain and inflammation associated with ocular surgery.
The randomized, double-masked, two-arm study evaluated the aqueous humor concentration of once-daily doses of BromSite versus Bromday in 58 subjects. Subjects were dosed two days before and the morning of the day of cataract surgery. Study results showed that the mean concentration of bromfenac in the aqueous humor of patients in BromSite's group was more than twice greater compared to those patients in Bromday's group with a P-Value of p=0.0032.
The Phase 2 PK clinical study was fully enrolled in six weeks using three sites in the United States under the direct supervision of the InSite Vision clinical department without the use of a contract research organization. BromSite and Bromday were both generally well tolerated and there were no safety concerns or serious adverse events related to either agent. InSite Vision intends to present a final analysis of the BromSite Phase 2 PK clinical trial in conjunction with a future scientific meeting.
In March, InSite Vision reported positive results from a Phase 1/2 clinical trial of BromSite which showed statistically significant superiority compared to vehicle (p=0.0016) for its primary endpoint (the absence of cells in the anterior chamber of the eye at day 15 post surgery). The results of the Phase 2 PK study and the earlier Phase 1/2 clinical trial hold the promise that BromSite may be a commercially superior NSAID for ocular surgical use. The company plans to initiate discussions with the U.S. Food and Drug Administration (FDA) on the design of the pivotal Phase 3 program for BromSite. Patent protection for BromSite is expected to extend into 2029.
"We are delighted that the study confirmed the superior penetration of BromSite against the current market leader, Bromday," said Dr. Kamran Hosseini, Vice President and Chief Medical Officer of InSite Vision. "Most physicians believe that a higher penetration of bromfenac into the ocular tissues of the eye may reduce the risk of cystoid macular edema, or CME, as a result of ocular surgery. CME is a relatively rare but extremely serious adverse event in ocular surgery that can lead to blindness. We are looking forward to working with the FDA to finalize the design of the Phase 3 program for BromSite and currently expect to begin pivotal trials in early 2012."
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 typically prescribed to reduce pain and inflammation and to enhance healing. Anti-inflammatory eye drops are currently used as prophylaxis against CME.
InSite Vision is advancing a second product candidate, known as ISV-101, that utilizes a low-concentration of bromfenac enabled by DuraSite for the treatment of dry eye disease. In January 2011, InSite Vision announced it had filed an Investigational New Drug (IND) application for ISV-101 with the FDA. The company is positioned to initiate a dose-ranging Phase 1/2 clinical trial in late 2011 or early 2012 to evaluate the safety and efficacy of ISV-101 when administered to patients suffering from dry eye disease. Patent protection for this drug candidate is also expected to extend into 2029.
InSite's DuraSite sustained delivery technology is a patented synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables topical delivery of a solution, gel or suspension and can be customized for delivering 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(R) (azithromycin ophthalmic solution) 1% and Besivanc(R) (besifloxacin ophthalmic suspension) 0.6%. InSite Vision is also applying DuraSite to multiple other clinical- and preclinical-stage product candidates to create a portfolio of novel ophthalmic products.
About InSite Vision
InSite Vision is advancing new and superior ophthalmologic products for unmet eye care needs. The company's product portfolio utilizes InSite Vision's proven DuraSite(R) bioadhesive polymer core technology, an innovative platform that extends the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite(R) (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance(R) (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch & Lomb and co-promoted by Pfizer Inc. InSite Vision's clinical-stage ophthalmic product pipeline includes AzaSite Plus(TM) (ISV-502) and DexaSite(TM) (ISV-305) for the treatment of eye infections, BromSite(TM) (ISV-303) for pain and inflammation associated with ocular surgery, and ISV-101 for the treatment of dry eye disease. 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, plans to discuss with the FDA possible future Phase 3 studies for BromSite (ISV-303) and the timing thereof, plans to initiate a Phase 3 study for BromSite (ISV-303) in early 2012, plans to initiate a Phase 1/2 clinical trial for ISV-101 and the timing thereof, expected indications for, and potential advantages of, BromSite (ISV-303) and ISV-101, the potential market size for BromSite (ISV-303) and ISV-101, the expected benefits of BromSite (ISV-303) and ISV-101 and the expected duration of patent protection for BromSite (ISV-303) and ISV-101. Such statements entail a number of risks and uncertainties, including but not limited to: the results of clinical trials for BromSite (ISV-303) and ISV-101; the timing of completion of the ISV-101 Phase 1/2 clinical trials, InSite's ability to obtain FDA approval to commence additional clinical trials for BromSite (ISV-303) or ISV-101 and the timing thereof; InSite's reliance on third parties for the commercialization of its products; the ability of InSite to enter into corporate collaborations for its product candidates; InSite's ability to expand its product platform 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, including those with respect to AzaSite; 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(R) and DuraSite(R) are registered trademarks of InSite Vision Incorporated.
BESIVANCE(R) is a registered trademark of Bausch & Lomb Incorporated.
SOURCE: InSite Vision Incorporated
Louis Drapeau, 510-747-1220
Chief Financial Officer
Michelle Corral, 415-794-8662
Karen Bergman, 650-575-1509