Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye, the greatest unmet medical need and largest potential market opportunity in ophthalmology. Macugen™ is being developed for the treatment of the wet form of age-related macular degeneration, known as AMD, and diabetic macular edema, known as DME.
Image Solutions, Inc. is a leading global provider of Electronic Submission services and software for the Life Sciences and other regulated industries. Eyetech initially enlisted ISI because of the firm’s proven and unique ability to provide high-quality, rapid turnaround outsourcing services for electronic document publishing, management, reporting and tracking while preparing for electronic submissions to regulatory agencies worldwide.
ISI’s service arm, ISI OneSource was uniquely qualified to accommodate Eyetech’s initial requirements for this submission and provided the regulatory operations expertise and services required to compile the first few sequences of their first eCTD submission. In addition to compiling the cumulative marketing application, ISI OneSource also provided some special arrangements like on-site scanning at Eyetech facilities and setup of a Quality Control facility at ISI headquarters, with overnight delivery of the eSubmission sequences to the FDA. The 2.4GB eSubmission consisted of almost a thousand (989) files, 117,047 pages, 68,884 hyperlinks, and 54,321 bookmarks.
After Eyetech and ISI completed the first few sequences of the submission, they decided to purchase ISI’s web-based solution, eCTDXPress to enable them to manage ongoing Safety Reports, Amendments and general responses to FDA questions normally required during the drug development lifecycle.
eCTDXPress facilitated secure document sharing across Eyetech’s enterprise and with regulatory agencies and provided minimal installation and validation challenges, allowing Eyetech to manage the balance of the eSubmission process themselves, and concentrate on their core business of drug development and regulatory strategy.
Eyetech Pharmaceutical, Inc.’s submission of their first eCTD was done in an effort to support their current FDA “Fast Track” status for their drug Macugen™, a process intended for products that address unmet medical needs. The eCTD was also entered into the "Pilot 1" program, which allows the FDA to complete reviews of individual reviewable units within six months of submission and provide early feedback on the pre-submissions. In addition, the FDA recently announced that it’s Dermatologic and Ophthalmic Drugs Advisory Committee reviewed Macugen™ on August 27, 2004.