Macugen gets favorable review

FDA's Dermatologic and Ophthalmic Drugs advisory committee gave a favorable review to an NDA from Eyetech (EYET) and partner Pfizer (PFE) for Macugen pegaptanib to treat wet, age-related macular degeneration (AMD). Although the panel was not specifically asked to recommend approval of the compound, the committee determined that sufficient data had been submitted to evaluate the compound's safety and efficacy.

In particular, the panel found that visual acuity data based on the ETDRS scale were "sufficiently robust" to overcome any potential bias introduced by visual acuity measurements at two meters instead of four meters, the distance at which FDA said the scale had been validated. The pivotal studies for approval of Visudyne verteporfin from partners QLT (QLTI) and Novartis (NVS; SWX:NOVN) to treat AMD also measured visual acuity at two meters. ...