FDA releases Macugen data

Friday's meeting of FDA's Dermatologic and Ophthalmic Drugs advisory committee is likely to discuss how Eyetech (EYET) measured visual acuity in its trials of Macugen pegaptanib in support of an NDA to treat exudative (wet) age-related macular degeneration (AMD). According to FDA, EYET used the ETDRS scale to measure visual acuity at two meters. However, FDA said the validity of the test was established at four meters, and the committee asked if EYET's visual acuity results are "sufficiently robust to overcome the potential bias introduced by visual acuity measurements at two meters." 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.

The FDA also asked if the concomitant use of photodynamic therapy (PDT) with Macugen has been sufficiently explored. In the Macugen trials, both Macugen and control patients with predominantly classic choroidal neovascularization (CNV) were eligible to receive PDT plus Visudyne at the discretion of the physician. ...