Novartis announced it is launching Lucentis (ranibizumab) in pre-filled syringe (PFS) formulation designed for intraocular injection in Germany. The product will be launched in other markets throughout this year.
Lucentis PFS is a novel way of drug administration for intraocular injection to improve patient safety and convenience of the treating clinician, in particular retinal specialists. The treatment received approval in Europe last October 2013.
David Epstein, Division Head o Novartis Pharmaceuticals, said “We are pleased to be able to offer a better way to accurately and safely administer Lucentis in the eye. Lucentis PFS brings convenience, safety, and the potential for improved efficiency and dose accuracy to both retinal specialists and patients.”
Ranibizumab, marketed under the brand name Lucentis, is an antibody fragment with a short systemic half-life designed specifically for ocular conditions. The drug is licensed in over 100 countries as treatment for wet age-related macular degeneration (wet AMD), diabetic macular edema-caused visual impairment, (DME) and for visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including both branch- and central-RVO.
“The Lucentis PFS has been specifically designed to reduce the risk of adverse events to patients and to enhance the treatment process in the clinic. This new injection technology offers the potential for improved safety for patients through a reduction in non-sterile preparatory steps and the inclusion of more safety features, such as a non-retractable plunger. Moreover, greater dose accuracy is possible through design features such as a smaller syringe barrel,” Novartis stated in its press release.
More than 43 extensive sponsored clinical studies established the safety profile of Lucentis. A clinical development program involving over 12,500 patients was conducted to establish Lucentis’ safety profile across indications.
The drug was co-developed by Novartis and Genentech. Novartis own exclusive rights outside U.S. while Genentech holds commercial rights in the U.S.