Phase 2 Study Highlights Efficacy and Safety Data of Complement Inhibitor for Geographic Atrophy
Patients treated with the complement inhibitor pegcetacoplan (APL-2, Apellis Pharmaceuticals) showed significant reduction in growth of geographic atrophy (GA) lesions compared with sham-treated eyes, according to 1-year data from the phase 2 FILLY study.1 The trial was a multicenter, randomized, single-masked study that investigated intravitreal pegcetacoplan for the treatment of GA secondary to age-related macular degeneration.
Patients received an intravitreal injection monthly or every other month for 12 months, followed by 6 months of monitoring after the end of treatment. The primary efficacy endpoint was the change in GA lesion area from baseline to month 12 compared with sham.
At 12 months, patients treated with pegcetacoplan showed a 29% reduction in the growth of GA lesion area in the monthly treatment group (P = 0.008) and a 20% reduction in the every-other-month treatment group (P = 0.067) in comparison with the pooled sham group. Statistical significance was defined as P < 0.1 for this study.
Administration of the drug was generally well tolerated.
1. Liao DS, Grossi FV, El Mehdi D, et al. Complement C3 inhibitor pegcetacoplan for geographic atrophy secondary to age-related macular degeneration: a randomized phase 2 trial [published online ahead of print July 16, 2019]. Ophthalmology.
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Graybug Vision Initiates Clinical Trial in Macular Edema Secondary to DME or RVO
A phase 2a, open-label, 6-month study will evaluate the long-acting pan-VEGF inhibitor GB-102 (Graybug Vision) in patients with macular edema secondary to diabetic macular edema (DME) or retinal vein occlusion (RVO), the drug’s developer announced in September. Researchers will enroll 20 patients and will treat them with a single intravitreal injection of 1 mg or 2 mg of GB-102.
GB-102 is a microparticle depot formulation of sunitinib malate, a pan-VEGF inhibitor. The company believes the formulation has the potential to be used as a semiannual treatment for wet age-related macular degeneration, DME, or RVO.
Proposed Legislation Would Permit Price Negotiation for Some Drugs
A bill introduced in the US House of Representatives in September would permit the federal government to negotiate prices of some drugs under Medicare and other health insurance programs. The proposal would empower the Department of Health and Human Services to annually negotiate the prices of at least 25 of the most expensive drugs lacking generic alternatives and as many as 250 other medicines, including insulin. It would also create an international pricing index linking US drug prices to those in other countries.
AAO and Verana Health Launch Tool to Improve Patient Care
The AAO and Verana Health in September introduced Verana Practice Insights, a tool that uses data insights and trends procured from the AAO’s Intelligent Research In Sight (IRIS) Registry to enable physicians to improve patient outcomes and provide better care, according to a joint news release from the AAO and Verana Health.
Verana Practice Insights gathers key data from the IRIS Registry to provide ophthalmologists with deidentified aggregate views of practice trends, patient diagnoses, and interventions across the United States.