FDA Approves Drugs for Wet AMD, Macular Edema Due to Uveitis

Ophthalmologists in the US will soon have more options in their toolkit to manage neovascular age-related macular degeneration (AMD) and macular edema associated with uveitis.

Susvimo, a 100 mg/mL ranibizumab injection for intravitreal use via ocular implant, has received FDA approval for wet AMD, and Xipere, a triamcinolone acetonide injectable suspension, has received FDA approval for the management of macular edema associated with uveitis.

The approval of Susvimo, which is expected to be available in the coming months, is based on positive results from the Phase III Archway study, which compared the efficacy of ranibizumab administered at fixed intervals every 6 months via refills of an eye implant with monthly intravitreal injections of 0.5 mg in 415 subjects with wet AMD who were not naïve to antivascular endothelial growth factor (anti-VEGF) injection. Patients on average had received five ranibizumab injections prior to their first study treatment visit.

Ranibizumab delivered via an ocular implant every 6 months was shown to be noninferior to monthly injections, as measured by the change in best-corrected visual acuity (BCVA) score from baseline at the average of Week 36 and Week 40. Patients receiving every 6-month treatment gained 0.2 eye chart letters from baseline compared with 0.5 eye chart letters for patients who received monthly injections.

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 maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule,” said Regillo in a news release issued by Genentech.

Four of 246 subjects (1.6%) in the implant therapy arm of the study received supplemental ranibizumab before the first scheduled refill.

The implant therapy was associated with a threefold increased rate of endophthalmitis compared with monthly injections of ranibizumab. According to the Genentech news release, “many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis.”

Other common adverse events were conjunctival hemorrhage, conjunctival hyperemia, iritis, and eye pain.

Another therapy that ophthalmologists in the US can look forward to using is Xipere, s triamcinolone acetonide injectable suspension, to manage macular edema associated with uveitis. The therapy received FDA approval today and is expected to be available in early 2022.

The approval of Xipere was based on results from PEACHTREE, a randomized, multicenter, double-masked, sham-controlled Phase 3 clinical trial of 160 patients with macular edema associated with uveitis.

The primary efficacy endpoint in that trial was the proportion of patients in whom BCVA had improved by at least 15 eye-chart letters from baseline after 24 weeks of follow-up. In the trial, a statistically significantly greater proportion of patients treated with Xipere (47%) achieved at least a 15-letter improvement in BCVA compared with patients in the control arm (16%; P <.01 at week>

The novel aspect of the therapy is that it uses a proprietary technology, the SCS Microinjector developed by Clearside Biomedical Inc, so that the therapy can be injected into the suprachoroidal space, according to Steven Yeh, MD, professor of ophthalmology and director of retinal disease and uveitis, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, and principal investigator for the PEACHTREE pivotal trial.

“The safety and efficacy data of Xipere was demonstrated in multiple clinical studies and its unique suprachoroidal administration approach provides exceptional access and high bioavailability to the posterior segment of the eye,” said Yeh in a news release issued by Bausch and Lomb and Clearside Biomedical Inc. “With the approval of Xipere, eye care professionals now have a new and innovative treatment option for their patients with macular edema associated with uveitis.”

According to the news release, targeted drug delivery via the suprachoroidal space may offer the advantage of limiting corticosteroid exposure to the anterior segment, thereby reducing the risk of adverse events such as cataracts, elevation in intraocular pressure, and exacerbation of glaucoma commonly linked to local drug delivery.

The most common adverse events reported by at least 10% of patients at a rate greater than control subjects included elevated intraocular pressure and eye pain.

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