BioCentury
ARTICLE | Clinical News

Fovista: Phase III started

September 2, 2013 7:00 AM UTC

Ophthotech began the first of 3 sham-controlled, international Phase III trials evaluating intravitreal injections of 1.5 mg Fovista in about 1,866 newly diagnosed wet AMD patients. According to in an S-1 filed by Ophthotech, the first 2 trials will enroll about 622 patients each to compare Fovista following intravitreal injections of 0.5 mg Lucentis ranibizumab vs. Lucentis alone. A third trial will compare Fovista following intravitreal injections of 2 mg Eylea aflibercept or 1.25 mg Avastin bevacizumab vs. Eylea and Avastin alone in about 622 patients. Ophthotech filed to raise up to $85 million in an IPO in August.

Ophthotech licensed rights to Fovista from Eyetech Inc., then a unit of OSI Pharmaceuticals Inc. OSI is now part of Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan). Archemix Corp. (Cambridge, Mass.) is eligible for milestones and royalties from Fovista based on a 2004 deal in which it granted Eyetech a license to aptamers for use in ophthalmic applications (see BioCentury, April 19, 2004 & July 30, 2007). In May, Ophthotech granted Novo A/S undisclosed royalties on Fovista sales in exchange for a financing of up to $125 million (see BioCentury, June 3). ...