On October 22, the FDA approved Genentech’s Susvimo refillable intravitreal ocular implant that dispenses 100 mg/mL of ranibizumab for patients with wet AMD. Patients will be approved for Susvimo provided that they have responded to at least 2 previous anti-VEGF injections. With the implant, treatment is only necessary at 6-month intervals.

The approval comes on the heels of the Archway study results, the phase 3 trial of Susvimo in which the implant proved noninferior to monthly ranibizumab injections at 24 months in terms of BCVA and retinal thickness outcomes. Ninety-eight percent of the 248 patients randomly allocated to receive Susvimo did not require supplemental treatment.

Although most adverse events in the Archway trial were not serious, there was a 3-fold higher rate of endophthlamitis reported with Susvimo than with monthly ranibizumab injections. This 2% rate of endophthalmitis appeared to be related to injury the conjunctiva. Consequently, Susvimo is being packaged with a box warning. Doctors are urged to emphasize early detection of conjunctival erosions or retractions.

“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,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development, in a press release. “Susvimo’s approval builds on Genentech's long-standing commitment to people living with vision-threatening conditions.”