FDA review date set for phakic IOL (intraocular lens):
This article was originally published in Clinica
Executive Summary
The US FDA has said it will review Ophtec USA and Advance Medical Optics' PMA submission for their phakic intraocular lens (IOL) on February 5, 2004. Already available in Europe, the Verisyse lens was granted expedited review status last August. It is aimed at the correction of nearsightedness in the range of -5 to -20 dioptres. The lens attaches to the periphery of the iris, without inhibiting the muscle's function. Santa Clara, California-based AMO is the distributor of the product in America and Japan, whilst Boca Raton, Florida firm Ophtec markets it in the rest of the world under the brand name Artisan.
You may also be interested in...
Incyte Hopes To Augment Immune/Inflammation Pipeline With Escient Deal
Incyte will pay $750m to acquire privately held Escient and its first-in-class oral antagonists of Mas-related G protein-coupled receptors X2 and X4.
Sanofi Clinches Key Phase III Immunology Win With Rilzabrutinib
Sanofi’s BTK inhibitor – one of two from its 2021 Principia buy – passed a Phase III test in immune thrombocytopenia as the company focuses on Dupixent-like blockbusters going forward.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.