Less frequent treatment for patients with wet AMD?
Quite possibly. Genentech announced detailed results from its phase 3 Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment of wet age-related macular degeneration (AMD).
Tell me about the study.
Patients received either PDS refilled every 6 months with a custom formulation of ranibizumab or monthly ranibizumab 0.5 mg eye injections. Patients had received prior treatment with anti-VEGF therapy and were confirmed anti-VEGF responders. The primary endpoint of the study measured the change from baseline in BCVA averaged over weeks 36 and 40.
What did they find?
Essentially 98% of patients with the PDS were able to go 6 months without requiring additional treatment and they achieved vision outcomes equivalent to patients receiving monthly eye injections of ranibizumab, a current standard of care. In the PDS arm, patients gained an average of 0.2 eye chart letters in visual acuity from baseline, with 98.4% (n = 244/248) of patients maintaining the fixed 6-month refill schedule within the first refill period. Patients treated monthly with ranibizumab gained an average of 0.5 letters in visual acuity from baseline.
The take home:
The PDS was shown to be noninferior and equivalent to monthly ranibizumab injections and was generally well-tolerated, with a favorable benefit-risk profile. Results from the Archway study will be submitted to health authorities around the world for consideration of regulatory approval for the treatment of wet AMD.
IN OTHER NEWS
More on the proposed VSP policy change.
A few weeks ago, I told you that starting September 1st, VSP plans to cut doctor reimbursements in half if doctors don’t prescribe certain brand lenses. According to a recent briefing from the American Optometric Association, these looming reimbursement policy changes may run counter to more than a dozen states’ patient protection laws. Per an AOA assessment, VSP’s new policy “will not only have the effect of restricting choice and undermining doctor-patient decision-making, but also breach patient protection laws on the books in 14 states.” The AOA has directly petitioned for a postponement of the policy in light of the ongoing COVID-19 pandemic.
What’s new in the race to secure a COVID-19 vaccine?
Pfizer and partner BioNTech are advancing the nucleoside-modified mRNA vaccine candidate BNT162b2 into phase 2/3 testing. The trial is expected to enroll up to 30,000 participants between 18 and 85 years of age who will be randomized to receive BNT162b2 or placebo, with study sites across the United States and several other countries. Primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization and prevention of COVID-19 regardless of whether participants have previously been infected by the virus. Secondary goals include preventing severe COVID-19 disease in these groups. (via)
Moderna has begun patient dosing in the phase 3 COVE study of its vaccine candidate mRNA-1273 against the novel coronavirus. The randomized study is expected to include roughly 30,000 participants in the United States testing the vaccine candidate at a dose of 100 mcg against placebo. Study volunteers will receive two intramuscular injections given approximately 28 days apart. The trial’s primary endpoint is prevention of symptomatic COVID-19 disease. Key secondary goals include prevention of severe COVID-19 disease defined by the need for hospitalization and prevention of infection by SARS-CoV-2 regardless of symptomology. (via)
SOCIAL MEDIA ROUNDUP
Looking for an eye-related gift for a colleague?
Check out these cool evil eye serving platters.
Ever hear of an ASMR eye exam?
It’s like telemedicine, but not. Let Dr. Lizi show you how it’s done.
See you next week!