FDA approves expansion of NeoVista's Phase III CABERNET trial

April 23, 2008

The FDA has approved an expansion of the Phase III CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial, which is evaluating the safety and efficacy of NeoVista's epiretinal brachytherapy in wet age-related macular degeneration (AMD).

The FDA has approved an expansion of the Phase III CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial, which is evaluating the safety and efficacy of NeoVista's epiretinal brachytherapy in wet age-related macular degeneration (AMD). There will now be 30 sites worldwide participating in the study, as opposed to the previously authorized 10, enrolling 450 subjects.

CABERNET, a multicentre, randomized, controlled study, will evaluate the safety and efficacy of NeoVista's epiretinal brachytherapy with Lucentis (ranibizumab; Novartis) versus Lucentis alone. Subjects in the brachytherapy study arm will receive an intravitreal injection of Lucentis and a single dose (24 Gy) of the epiretinal brachytherapy; these subjects will receive a second intravitreal Lucentis injection approximately one month later.

The trial aims to prove either the non-inferiority or the superiority of epiretinal brachytherapy plus Lucentis versus Lucentis alone at 12 months from baseline. Visual acuity (VA) of study subjects will be measured on the ETDRS scale.

NeoVista's Phase II trial, evaluating brachytherapy in combination with Avastin (bevacizumab), demonstrated an improvement in mean VA in subjects using brachytherapy plus Avastin; adverse events in the Phase II trial were limited to vitrectomy-related problems and not to radiation toxicity. The approved expansion of CABERNET was dependent on the FDA's review of 90-day safety data.