Eyetech completes Macugen NDA

(EYET) and partner Pfizer (PFE) completed the submission of a rolling NDA with the FDA for Macugen pegaptanib sodium injection to treat exudative (wet) age-related macular degeneration (AMD). The companies are seeking approval for the 0.3 mg dose of Macugen, which was the lowest dose tested in Phase II/III trials supporting the NDA. The NDA has Fast Track designation and also is part of the Pilot 1 program, which allows FDA to complete reviews of the individual NDA units within six months of submission and provide early feedback on the pre-submissions. The FDA's Dermatologic & Ophthalmic drugs advisory committee also will review the NDA on Aug. 27. ...