Novartis has announced the launch of the Lucentis (ranibizumab) pre-filled syringe (PFS) in Germany, with other markets to follow throughout 2014. The Lucentis PFS, which received European approval in October 2013, is a new way of administering Lucentis that is specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.
"We are pleased to be able to offer a better way to accurately and safely administer Lucentis in the eye," said David Epstein, Division Head, Novartis Pharmaceuticals. "Lucentis PFS brings convenience, safety, and the potential for improved efficiency and dose accuracy to both retinal specialists and patients."
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.
These features combined may equate to reduced waiting times and thereby improve the patient treatment experience.
Lucentis is the first choice to save sight owing to its unsurpassed efficacy and uncompromised safety profile. As an antibody fragment with a short systemic half-life, Lucentis was specifically designed, developed, formulated and licensed for ocular conditions, and is manufactured to the highest standards for intra-ocular use.
Lucentis is licensed in more than 100 countries, for the treatment of wet age-related macular degeneration (wet AMD), visual impairment due to diabetic macular edema (DME) and for visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including both branch- and central-RVO. Also, Lucentis is licensed in 50 countries for the treatment of patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). In most countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.
Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 2.4 million patient-treatment years of exposure since its launch in the United States in 2006.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.