Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Miravant Plans Photrex Confirmatory Macular Degeneration Trial

This article was originally published in The Pink Sheet Daily

Executive Summary

The trial, to be conducted under a special protocol assessment with FDA, will be one year with another year for confirmatory results. Agency's September 2004 "approvable" letter for the photodynamic therapy requested an additional study. Miravant is also planning combination studies with other age-related macular degeneration agents.

You may also be interested in...



Pfizer/Eyetech Macugen To Launch In First Quarter With "Unambiguous" Label

The ophthalmic agent clears FDA under priority review procedures; "It is for all neovascular" age-related macular degeneration, Eyetech COO says. Company expects Macugen will receive broad coverage under Medicare Part B.

Miravant's SnET2 Requires Additional Clinical Trial For Macular Degeneration

FDA needs further confirmation before granting full approval to the photosensitive drug/photodynamic therapy combination, Miravant says. The firm is seeking approval for both predominantly and minimally classic AMD.

Predicting Success: The Easiest, And Hardest Routes To Market

A new analysis from BIO, Informa Pharma Intelligence and QLS looks at clinical drug development activity from the past decade, looking at the most (and least) successful areas. Infographic depicts key trends and details.

Topics

UsernamePublicRestriction

Register

OM016808

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel