Miravant is initiating a 600-patient confirmatory trial of its macular degeneration therapy Photrex (rostaporfin, SnET2), the firm says March 10. The FDA-requested trial's design, reviewed under a special protocol assessment, will evaluate a range of patients with wet age-related macular degeneration, including both classic and occult lesions" (1Pharmaceutical Approvals Monthly February 2005, p. 16)...

The final decision on Pfizer/Eyetech’s Macugen awaits review of the chemistry and manufacturing sections of the NDA, FDA said during the Dermatologic & Ophthalmic Drug Products Advisory Committee’s Aug. 27 review of the clinical data.

Eyetech plans to submit its VEGF inhibitor Macugen in the third quarter for use in the three subtypes of wet age-related macular degeneration, the company noted in a prospectus for an initial public offering.