SCOTTSDALE, Ariz., Sept. 29 NeoVista, Inc. made publicyesterday 18-month data from the company's Phase II feasibility studyexamining its novel epiretinal brachytherapy for treatment of the wet form ofage-related macular degeneration (AMD) at the 41st Scientific Meeting of theRetina Society. The long-term data from the study, which was initiated to testthe safety and efficacy of their therapy when used in conjunction withAvastin(R) (bevacizumab), showed a marked advancement in mean visual acuityresults at month 18, while only a limited number of patients requiredadditional injections of Avastin.
"We're very delighted with the latest data from our Phase II study, as notonly did the visual acuity improve in our patients over the long-term, butvery few patients received additional injections as well," said John N.Hendrick, President and CEO of NeoVista. "The ultimate pledge of this therapycontinues to be demonstrated as the long-term data hold promise in minimizingthe treatment burden both for patients and physicians, not to mention theoverall financial burden for the healthcare system."
NeoVista's revolutionary therapy applies a targeted dose of beta radiationto the leaking blood vessels that affect central vision; concomitantly, twoinjections of an antivascular endothelial growth factor (anti-VEGF) agent aredelivered to maximize the acute therapeutic response. Preliminary data showthat NeoVista's targeted radiation therapy can be safe for both the patientand the physician, and may be able to restore the patient's vision. Thecurrent standard of care for wet AMD requires persistent injections ofanti-VEGF drugs for an indefinite period.
The ongoing multicenter feasibility study enrolled 34 trial participants(with a mean age of 72 years) from June 2006 to April 2007 at two centers inBrazil and one in Mexico. These patients, with predominantly classic,minimally classic, or occult (with no classic) choroidal neovascularization(CNV), received a single 24 Gy treatment of NeoVista's epiretinalbrachytherapy in combination with two intravitreal injections of Avastin, onedose prior to or at the time of radiation delivery and another one monthlater, depending on which arm of the trial the patient was enrolled in.Additional therapy was delivered based upon the investigator's evaluation ofdisease activity.
Analysis of 18-month follow-up on the first 25 trial participants to reachthat milestone shows a mean improvement in visual acuity of 10.7 letters usingthe Early Treatment Diabetic Retinopathy Study (ETDRS) test; 96 percent ofpatients lost 15 letters or fewer, 76 percent gained some letters, 44 percentgained 15 or more letters, and 8 percent gained 30 or more letters. Ofparticular interest, 68 percent of the patients in the study did not requireadditional injections of Avastin throughout the 18-month period and theaverage number of additional injections within this subset was only 2.4injections by month 18.
Most of the limited number of adverse events were related to thevitrectomy procedure (retinal tear, retinal detachment, subretinal hemorrhage,and vitreous hemorrhage), rather than the epiretinal brachytherapy. To date,no instances of radiation toxicity have been reported by the Doheny readingcenter.
The data were presented at the Retina Society Meeting by Nelson R.Sabates, MD, Professor and Chairman, Department of Ophthalmology, Universityof Missouri-Kansas City (UMKC) School of Medicine and the lead investigator inNeoVista's ongoing Phase III study, CABERNET (CNV Secondary to AMD Treatedwith BEta RadiatioN Epiretinal Therapy).
"The data released demonstrate that NeoVista's concomitant approach hasthe potential to offer patients a less frequent treatment option that is justas effective, if not more effective, than the current standard of care," saidDr. Sabates. "It's highly encouraging to continually see patient outcomesimproving as the study progresses."
In contrast to other forms of radiation therapy for wet AMD, NeoVista'sapproach delivers the peak dose of energy directly to the lesion withoutdamaging the normal retinal vasculature. Utilizing strontium 90, the focusedenergy is delivered to a target area up to 3 mm in depth and up to 5.4 mm indiameter. Importantly for patients, the systemic exposure to radiation isminimal, as the effective dose to the entire body from NeoVista's epiretinaldevice is less than that from a typical chest x-ray.
With the continued promise of these Phase II trial results, NeoVistacontinues to enroll patients in the company's pivotal trial, CABERNET.CABERNET is a multicenter, randomized, controlled study that will enroll 450subjects at 45 sites worldwide, evaluating the safety and efficacy ofNeoVista's epiretinal brachytherapy delivered concomitantly with theFDA-approved anti-VEGF therapy Lucentis(R) (ranibizumab) versus Lucentisalone.
"The Royal National Institute of Blind People (RNIB) welcomes the resultsof the Phase II study for NeoVista's therapy, which may increase the treatmentoptions for people with wet AMD," said Barbara McLaughlan, RNIB CampaignsManager for Eye Health and Social Care. "It is our hope that these results areconfirmed in the Phase III trial that is now being conducted as wet AMD is theleading cause of sight loss in the UK and patients need a variety of choicesof proven treatments to be available in the National Health Service so theycan choose the therapy that's best for them."
About NeoVista, Inc.
NeoVista, Inc. is a privately held development-stage medical devicecompany based in Fremont, California. NeoVista's epiretinal beta radiationtherapy is currently being studied in a definitive Phase III clinical study tosupport eventual filing for regulatory approval to market the product in theUnited States. For more information about the company, the clinical trial orthis novel wet AMD therapy, please visit the company's Web site athttp://www.neovistainc.com.Contact: Tony Moses O: 510-933-7600 C: 510-402-3394 [email protected]
SOURCE NeoVista, Inc.