USA – The FDA has approved ranibizumab 100 mg/mL injection for wet age-related macular degeneration in patients who have previously responded to at least two anti-VEGF injections, according to Genentech.
The new therapy (Susvimo), formerly known as the Port Delivery System (PDS) with ranibizumab, is designed for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, Age-Related Macular Degeneration (AMD).
This is the only FDA-approved wet AMD therapy that allows for as few as two treatments per year.
The availability of Susvimo will decrease the frequency of anti-VEGF injections, according to Carl Regillo MD, chief of retina service at Wills Eye Hospital in Philadelphia and an Archway study investigator.
“With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule,” Ocular Surgery News Editorial Board Member Carl D. Regillo, MD, chief of retina service at Wills Eye Hospital, said in the release.
According to the press release, Genentech’s newly approved treatment for wet AMD is a viable alternative to anti-VEGF eye injections, which are required as frequently as
The Susvimo ocular implant continuously delivers 100 mg/mL of ranibizumab directly to the retina over a 6-month period.
The initial implantation and refill can be done during an ophthalmologist’s office visit. Conventional intravitreal anti-VEGF therapy, on the other hand, necessitates injections as frequently as once a month.
Patients who have previously responded to at least two intravitreal injections of anti-VEGF therapy are eligible for approval.
If a patient requires additional anti-VEGF therapy, injections can be given while the implant is still in place.
The approval is based on the ARCHWAY phase 3 study’s positive results. The study was recently reported at the American Society of Retina Specialists meeting.
The trial demonstrated that continuous-release ranibizumab was equivalent to monthly injections of ranibizumab (Lucentis) in terms of best-corrected visual acuity and central point thickness.
More than 98 percent of patients randomized to the continuous-release system did not require supplemental anti-VEGF therapy prior to refill at 6 months.
Xipere, a triamcinolone acetonide injectable suspension, is another therapy that ophthalmologists in the United States can look forward to using to treat macular edema caused by uveitis.
The therapy has also been approved by the FDA, and is expected to be available in early 2022.
PEACHTREE, a randomized, multicenter, double-masked, sham-controlled Phase 3 clinical trial of 160 patients with macular edema associated with uveitis, was used to support Xipere’s approval.
Xipere therapy is novel in that it uses a proprietary technology, the SCS Microinjector developed by Clearside Biomedical Inc, to inject the therapy into the suprachoroidal space.
Targeted drug delivery via the suprachoroidal space may have the advantage of limiting corticosteroid exposure to the anterior segment, thus, lowering the risk of adverse events such as cataracts, intraocular pressure elevation, and glaucoma exacerbation that are commonly associated with local drug delivery.