Roche's intravitreal implant as effective as Lucentis eye injections in AMD: study

Roche announced Wednesday that in a Phase III study, patients with neovascular age-related macular degeneration (AMD) who received ranibizumab via the port-delivery system (PDS), with refills every six months, achieved visual acuity outcomes equivalent to those given monthly injections with Lucentis (ranibizumab), meeting the study's primary endpoint. The company noted that results from the Archway trial will be used for regulatory filings, including in the US and Europe.

"For people around the world receiving frequent eye injections for neovascular AMD, this continuous delivery system could greatly reduce their treatment burden," remarked Levi Garraway, Roche's head of global product development. The PDS is a permanent refillable eye implant, approximately the size of a grain of rice, designed to continuously release a customised formulation of ranibizumab into the eye over time. The intravitreal injection formulation of the drug, marketed as Lucentis by Roche and Novartis, is approved to treat neovascular AMD and other retinal diseases

'Underestimated' potential

The Archway study randomised 418 people living with neovascular AMD to receive the PDS with ranibizumab, refilled every six months at fixed intervals, or monthly intravitreal injections of Lucentis. The trial's primary endpoint was the change in best-corrected visual acuity (BCVA) score from baseline at the average of week 36 and week 40, while secondary goals include overall change in BCVA from baseline, as well as change from baseline in centre point thickness over time. The PDS "was generally well-tolerated with a favourable benefit-risk profile," Roche said. Full results from the study will be presented at an upcoming medical meeting.

Commenting on the news, Zuercher Kantonalbank analyst Michael Nawrath said that the potential of the PDS has been "underestimated," and that he is projecting $4 billion in peak sales for the port.

Roche gained the PDS via the purchase of ForSight VISION4 in 2017. Meanwhile, the Portal study is investigating the long-term safety and tolerability of the PDS for the treatment of neovascular AMD, while the Pagoda trial is assessing the technology for the treatment of diabetic macular oedema.