MONZA (ITALPRESS) – Roche announced that the Italian Pharmaco Agency (AIFA) approved the reimbursement to the SSN for the new formulation of pre-filled syringes (PFS) for use in the treatment of macular degeneration linked to the neovascular age or “humid” (nAMD), of the macular edema of diabetic (DMEculation). These are retinal pathologies that have a strong impact on the quality of life of patients and their caregiver and that overall, affect almost 80 million people worldwide, representing some of the main causes of loss of sight. “The availability of pre-filled syringes is a significant step forward because it combines clinical effectiveness with improved practicality. Ensuring the control of the disease with more extensive intervals between injections and reducing the complexity of administration makes the entire therapeutic path more sustainable for patients and their caregiver”, says Francesco Bandello, Director of the Ophthalmology Unit of the IRCS Hospital San Raffaele in Milan and President of the Association Patients Ocular Diseases. The pre-filled phylocymab syringe (PFS) represents the first and only ready-to-use solution containing a two-specific antibody for the treatment of macular degeneration linked to the neovascular age (nAMD), diabetic macular edema (DME) and secondary macular occlusion to retinal venous occlusion (RVO). The availability of PFS allows retinal specialists to reduce preparation times and potentially lighten the caregiver load for patients and caregiver, without compromising effectiveness and safety. “Roche is constantly committed to finding innovative solutions to improve the treatment experience of people living with vision pathologies. A new pre-filled and ready-to-use syringe can help simplify treatment management in the everyday life of healthcare professionals and patients,” says Laura Bianchino, Medical Unit Leader Ophthalmology in Roche. In support of the favorable profile of the therapy, several studies have confirmed the effectiveness and tolerance of faricimab in clinical practice. The FARIT study, the first Italian real-world study on faricimab with a follow-up of at least 12 months, highlighted encouraging results in terms of effectiveness and tolerance in everyday clinical practice. According to the FARIT study, in fact, the therapy allowed an effective control of the disease, with an extension of treatment intervals compared to those previously obtained with other anti-VEGF. Specifically, about 60% of naive patients with nAMD received injections every 4 months (Q16W) already after the loading phase, with only 3 injections in the next 12 months, while 100% of native patients with DME reached the Q16W range at 1 year, requiring only 2 injections in the 10 months after the loading phase. These real-world data are further supported by the AVONELLE-X study, the largest long-term extension study in NAMD. AVONELLE-X showed visual stability and maintenance of anatomical improvements, with almost 80% of patients who could extend treatment intervals to 3 or 4 months, confirming the maintenance of disease control and treatment duration for over 4 years. The RHONE X 24 study confirmed at the end of the 4 years that, even in the DME, almost 80% of the participants treated with faricimab had prolonged treatment intervals up to three or four months. Moreover, in a default exploratory endpoint, more than 90% of the subjects treated with faricimab highlighted the absence of DME after 4 years. For patients with retinal venous occlusion (RVO), the effectiveness and safety data of two phase III, BALATON and COMINO international clinical trials have highlighted premature and lasting improvements in visual acuity and significant reabsorption of retinal fluid, allowing many patients to extend treatment intervals up to four months. Faricimab is the first and only bispecific antibody approved for eye use, designed to affect and inhibit two signaling routes connected to various retinal pathologies that threaten sight; acts by neutralizing both angiopoietin 2 (Ang-2) and the vascular endothelial growth factor A (VEGF-A) to restore vascular stability.
– photo print office Roche –(ITALPRESS).
