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Wednesday, May 27, 2020

Roche eye implant successful in late-stage wet AMD study

Roche (OTCQX:RHHBY) announces positive results from a Phase 3 clinical trial, ARCHWAY, evaluating its Port Delivery System (PDS) with ranibizumab in patients with neovascular age-related macular degeneration (wet AMD).
The study met the primary endpoint demonstrating that patients with PDS who received refills every six months achieved equivalent improvements in visual acuity compared to patients receiving monthly ranibizumab 0.5 mg injections.
On the safety front, PDS was generally well-tolerated with a favorable benefit-risk profile.
PDS is a permanent refillable eye implant about the size of a grain of rice that continuously delivers a customized formulation of ranibizumab over a period of months.
The company markets the injectable formulation of ranibizumab as Lucentis.
Complete results will be presented at an upcoming medical conference and submitted to global health authorities for potential approval.

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