By Dr. Joshua Mali
I am very excited to announce the recent FDA approval of Genentech’s Susvimo, previously called the Port Delivery System (PDS) with ranibizumab (Lucentis, Genentech), the first wet, or neovascular, AMD treatment in 15 years to provide an alternative to standard-of-care eye injections needed as often as once a month. The drug is billed as a first-of-its-kind therapeutic approach for wet age-related macular degeneration (AMD) and may help people with the disease maintain their vision with as few as 2 treatments annually.
According to Genentech, the treatment is for intravitreal use via ocular implant to treat people with wet AMD who have previously responded to at least 2 anti-vascular endothelial growth factor (VEGF) injections. The company stated that Susvimo is the first and only FDA-approved treatment for wet AMD that offers as few as 2 treatments per year.
Genentech noted that Susvimo delivers ranibizumab continuously, offering patients living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every 6 months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place. According to the company, the FDA approval comes after positive results from the randomly assigned multicenter Phase III Archway study primary analysis, which showed wet AMD patients treated with Susvimo achieved and maintained visual gains equivalent to monthly ranibizumab injections – +0.2 and +0.5 eye chart letters from baseline, respectively – at weeks 36 and 40 of treatment.
Susvimo, which contains 100 mg/ml of ranibizumab, was non-inferior and equivalent to monthly 0.5-mg ranibizumab injections for changes in the best-corrected visual acuity compared with baseline at the average of weeks 36 and 40 and remained non-inferior through 2 refill-exchange intervals at the average of weeks 44 and 48. The visual and anatomic results with the PDS were comparable to those with monthly ranibizumab through week 72 regardless of the presence or absence of subretinal or intraretinal fluid. Moreover, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill. In the Archway study, Susvimo was generally well-tolerated, with a favorable benefit-risk profile.
Genentech has a robust phase III clinical development program for Susvimo, including the Portal, Pagoda, Pavilion, and Velodrome studies. Portal is an extension study evaluating the long-term safety and efficacy of Susvimo in wet AMD. Pagoda is evaluating Susvimo for the treatment of people with diabetic macular edema (DME), while Pavilion is a study of Susvimo in diabetic retinopathy without DME. Velodrome is evaluating Susvimo refilled every 9 months in wet AMD. Susvimo is also currently under review for the treatment of wet AMD by the European Medicines Agency.
According to Genentech, Susvimo will be available in the United States in the coming months, and the company is committed to helping patients access the medicines they are prescribed and will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement.
Susvimo represents a big victory for patients with wet AMD and it is an honor for me as a retinal specialist to provide my patients with the most cutting-edge technology to give them the best vision possible.
New program: Susvimo Port Delivery System (PDS Everything You Need to Know! December 10th @ noon Please check our website @ https://macularhope.org/webinar-programs/ for more information
Joshua Mali, MD, is a board-certified ophthalmologist and award-winning vitreoretinal surgeon at The Eye Associates, a private multi-specialty ophthalmology practice in Sarasota, Florida. He is the Retina Medical Director of the Macular Degeneration Association (MDA). He is also the Founder & CEO of Mali Enterprises (www.malienterprises.org).