Roche on Friday obtained FDA approval for its Susvimo ocular implant to treat patients with wet age-related macular degeneration (AMD) who have previously responded to at least two anti-VEGF injections. Susvimo is designed to continuously administer a customised formulation of the company's VEGF antagonist ranibizumab, which is currently sold as the intravitreal injection Lucentis, over several months.
Roche noted that the implant, previously referred to as a port delivery system, is the first FDA-approved treatment for wet AMD that offers "as few as two treatments per year," and also the first to come along in 15 years that provides an alternative to standard-of-care eye injections which sometimes have to be given as often as once a month. "We believe that Susvimo can help people with wet AMD preserve their vision while potentially alleviating the treatment burden associated with current standards of care," remarked chief medical officer Levi Garraway. Roche says Susvimo will be available in the US in the coming months.
The filing is supported by results from the Phase III Archway study primary analysis, which showed that Susvimo allowed patients to achieve and maintain vision improvements equivalent to monthly Lucentis injections – with gains of +0.2 and +0.5 eye chart letters from baseline, respectively – averaged over weeks 36 and 40. In addition, more than 98% of Susvimo patients could go six months before their first ranibizumab refill.
However, the Archway results also showed that 2% of patients receiving the implant experienced at least one episode of endophthalmitis – a three-fold higher rate than what was seen with monthly Lucentis injections. "Many of these events were associated with conjunctival retractions or erosions," Roche explained, adding that "appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk." The most common adverse events were conjunctival haemorrhage, conjunctival hyperaemia, iritis and eye pain. Roche said Susvimo's "safety profile…in the clinical trial setting is well understood and will continue to be monitored closely."
The FDA first approved Lucentis for wet AMD in 2006, with its label subsequently cleared for other retinal diseases as well. Susvimo is also currently under review for the treatment of wet AMD by the European Medicines Agency.
The Phase III development programme for Susvimo includes several other studies. Portal is an extension study evaluating the long-term safety and efficacy of Susvimo in wet AMD. In addition, the Pagoda trial is testing the implant as a treatment for diabetic macular oedema (DME), while Pavilion is investigating it in diabetic retinopathy without DME. Meanwhile, Velodrome is evaluating Susvimo refilled every nine months in wet AMD.
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