麻豆传媒

The FDA has approved a first-of-its kind continuous delivery system for anti-VEGF therapy for neovascular (wet) age-related macular degeneration (AMD).

The Susvimo ocular implant continuously releases 100 mg/mL of ranibizumab directly to the retina over 6 months. Initial implantation and refill can be performed during an office visit with an ophthalmologist. In contrast, conventional intravitreal anti-VEGF therapy requires injections as often as once a month. The approval is for patients who previously responded to at least two intravitreal injections of anti-VEGF therapy.

"Susvimo represents a major advancement in the treatment of retinal disease and is an important new option for patients with wet AMD," said Carl Regillo, MD, of Wills Eye Hospital in Philadelphia, in a from developer Genentech. "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."

If a patient requires supplemental anti-VEGF therapy, injections can be performed with the implant in place.

Support for the approval came from the phase III Archway study, recently reported at the American Society of Retina Specialists meeting. The trial demonstrated the equivalence of continuous-release ranibizumab to monthly injections of ranibizumab (Lucentis) with respect to best-corrected visual acuity and central point thickness. Among patients randomized to the continuous-release system, more than 98% did not require supplemental anti-VEGF therapy prior to refill at 6 months.

The ocular implant system was associated with a higher rate of endophthalmitis as compared with monthly injections (about 2% in multiple clinical trials). Most cases were associated with conjunctival retraction or erosion. Appropriate conjunctival management and early detection and repair of retractions/erosions may reduce the risk of endophthalmitis, according to the company statement.

The company said the continuous delivery system will be available "in the coming months" but did not specify a release date.

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