Genaera Evizon macular degeneration SPA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genaera plans to begin two identical pivotal trials of Evizon (squalamine) "in the very near future" following a special protocol assessment agreement with FDA, the firm says June 27. The trials will enroll patients with predominantly classic, minimally classic and occult forms of wet age-related macular degeneration. The primary endpoint will be visual acuity at one year; maintenance dosing will continue through two years. Genaera has three Phase II trials of Evizon ongoing. FDA selected the anti-angiogenic agent for its continuous marketing application Pilot 2 program earlier this year; the program provides frequent feedback and interaction with the agency during the IND phase of development (1Pharmaceutical Approvals Monthly January 2005, In Brief)...
You may also be interested in...
Squalamine selected for Pilot 2
FDA taps Genaera's anti-angiogenic squalamine for its Continuous Marketing Application Pilot 2 program, the firm announces Jan. 4. Squalamine was selected by CDER's Division of Anti-Inflammatory, Analgesic and Ophthalmic Drug Products; the program provides frequent scientific feedback and interaction during the IND phase, with each review division choosing one participant. Squalamine is being developed for "wet" age-related macular degeneration. Phase II trials are underway, with data expected in the first quarter. Genaera plans to begin Phase III in the first half of 2005, to run concurrently with its largest Phase II study...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.