SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug maker Roche (RHHBY) announced Wednesday positive topline results from the phase III Archway study, evaluating Port Delivery System with ranibizumab in people living with neovascular or 'wet' age-related macular degeneration or nAMD.
Port Delivery System with ranibizumab or PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customised formulation of ranibizumab over a period of months.
The company noted that the Archway trial met its primary endpoint, demonstrating that patients with PDS who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab 0.5 mg injections.
In Archway, PDS was generally well-tolerated with a favorable benefit-risk profile.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said, 'For people around the world receiving frequent eye injections for neovascular AMD, this continuous delivery system could greatly reduce their treatment burden.'
The company expects to present detailed Archway results at an upcoming medical meeting and to submit to regulatory authorities across the world.
The Portal study is also investigating the long-term safety and tolerability of PDS for the treatment of nAMD. PDS is also being studied in the Pagoda trial for the treatment of diabetic macular edema or DME, a vision-threatening complication of diabetes.
Copyright RTT News/dpa-AFX
© 2020 AFX News
