Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), are expected to submit an Investigational New Drug (IND) application for clinical testing of a new refillable drug port delivery system, designed to release Lucentis over a period of months. At present, Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of wet AMD and for macular edema following RVO. A supplemental Biologics License Application (sBLA) for Lucentis for the treatment of patients with diabetic macular edema (DME) is currently under review by the FDA. The recommended administration of Lucentis is by monthly injection to the eye, which significantly increases costs and clinical visits for patients while additionally increases the risks of negative side effects associated with ocular injection, including pain, retinal detachment, haemorrhaging and infection. The prospect of avoiding direct ocular injection through the use of a refillable device for the sustained delivery of Lucentis could radically alter clinical management of several retinal disorders.
Genentech and device maker ForSight VISION 4 Inc. progress on sustained delivery device for Lucentis
- by swdadmin