Apellis Pharmaceuticals has announced long term results from their Phase 3 DERBY and OAKS clinical studies, testing the efficacy and safety of APL-2 (now called intravitreal pegcetacoplan), as a treatment for geographic atrophy (GA). GA is also known as advanced dry age-related macular degeneration.
In an analysis conducted at month 18 of the clinical studies, treatment with both monthly and every-other-month pegcetacoplan reduced GA lesion growth compared to sham injections (no treatment). Pegcetacoplan continued to demonstrate a favorable safety profile in both studies.
Overall, these longer-term results provide further evidence that pegcetacoplan meaningfully slows disease progression and has the potential to preserve vision longer.
Apellis remains on track to submit a New Drug Application to the U.S. Food and Drug Administration in 2022. This is one of the first steps towards potentially achieving approval for use. They also look forward to working with global regulatory groups to bring forward the first potential treatment for people living with GA.
Pegcetacoplan is the only targeted C3 therapy in Phase 3 clinical trials for GA, a complement-driven eye disease that causes loss of central vision, affects approximately five million people globally and has no approved treatment.
According to SriniVas Sadda, M.D., President & Chief Scientific Officer of the Doheny Eye Institute and lead investigator, “This study provides exciting evidence to support further exploration of the potential of pegcetacoplan for earlier intervention in the course of GA.”
For current information about all major research for treatment of geographic atrophy, see “A Guide to Research in Dry AMD” on this site.
Related earlier articles:
Apellis Entering Phase 3 Trials for Dry Macular Degeneration (2017)
SOURCE: Press Release
The FDA has approved Genentech’s Vabysmo (first announced here as faricimab), the only injectable eye medicine approved simultaneously in the U.S. for wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
Vabysmo will be administered using flexible dosing regimens based on patient need. The medication targets and inhibits two disease pathways by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), which drive the two conditions.
Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses. Standard of care for wet AMD and DME typically requires eye injections every one to two months.
“Vabysmo represents an important step forward for ophthalmology,” said Charles Wykoff, M.D., Ph.D. (Director of Research, Retina Consultants of Texas in Houston and a Vabysmo Phase III investigator). “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”
The approval is based on positive results across four Phase III studies in wet AMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus Regeneron’s Eylea (aflibercept) given every two months in the first year. Vabysmo was generally well tolerated in all four studies, with a favorable benefit-risk profile.
More information and details about the research may be read here.
SOURCE: Genentech Press Release
Researchers at Kaiser Permanente Washington have found strong evidence that cataract surgery can lower the risk of developing dementia for up to 10 years in senior adults. The news was reported in the December 6, 2021 issue of JAMA Internal Medicine.
The Adult Changes in Thought (ACT) study of more than 5,000 senior adults showed for the first time that subjects who underwent cataract surgery had nearly a 30% lower risk of developing dementia than those who did not. The study also showed an association between cataract surgery and a lower risk of Alzheimer’s disease. The reason/s for these findings were not reported, but the most reasonable hypothesis is that improved vision quality and light input might benefit the brain—welcome news in light of recent reports showing that dementia from Alzheimer’s disease (AD) is often associated with retinal degeneration. For more information about this, see Retinal Degeneration and Alzheimer’s Disease: An Evolving Link.
SOURCE: “Association Between Cataract Extraction and Development of Dementia” by Cecilia S. Lee, MD et al, 6 December 2021, JAMA Internal Medicine. DOI: 10.1001/jamainternmed.2021.699
Frequent Eye Injections May Soon Be History
Genentech Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) is giving priority review for the company’s Port Delivery System for the treatment of wet age-related macular degeneration (AMD). If approved, PDS will be a first-of-its-kind therapeutic approach, offering people living with wet AMD an alternative to frequent eye injections. The FDA is expected to make a decision on approval by Oct. 23, 2021.
As reported here earlier, PDS is a permanent refillable eye implant, approximately the size of a grain of rice, designed to continuously deliver a customized formulation of Lucentis over a period of up to six months with no reduction in safety or efficacy.
Genentech has a robust Phase III clinical development program underway for PDS, including the Portal, Pagoda and Pavilion studies. Portal is an extension study evaluating the long-term safety and efficacy of PDS in wet AMD. Pagoda is evaluating PDS for the treatment of diabetic macular edema (DME), while Pavilion is a study of PDS in diabetic retinopathy without DME. Both the Pagoda and Pavilion trials are actively recruiting participants.
SOURCE: Genentech Press Release
Sometimes it seems that retina research moves at a snail’s pace, but science is steadily moving toward those treatments and cures that will keep our eyes healthy. This is an update on four therapeutics just around the corner for treatment of age-related macular degeneration (AMD). Of the hundreds of ongoing clinical trials for both wet and dry AMD, these are the ones offering the most hope in the coming months.
Regenxbio’s RGX-314 uses a new method of inhibiting blood vessel growth (neovascularization) in wet age-related macular degeneration (wAMD). It differs from current therapeutics in that it includes a gene vector (NAV AAV8) which encodes an antibody fragment designed to neutralize VEGF (vascular endothelial growth factor) activity. As of December 31, 2020, delivery of RGX-314 was reported to be generally well-tolerated, with no evidence of inflammation. More information.
Roche has been studying faricimab for treatment of wet age-related macular degeneration (wAMD). The efficacy of faricimab administered at 12- and 16-week intervals was evaluated against ranibizumab (Lucentis) every 4 weeks. By January 2021, research had shown that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes as effective as those receiving Regeneron’s aflibercept (Eylea) injections every eight weeks. Roche looks forward to submitting the data to global regulatory authorities, with the aim of bringing this new treatment option as soon as possible to patients. More information.
Port Delivery System
Developed by Genentech, the Port Delivery System (PDS) is a permanent eye implant about the size of a grain of rice that continuously releases a modified version of Lucentis. Once FDA approved, patients with wet age-related macular degeneration (wAMD) would visit their doctors only twice a year to refill the device–a significantly less burdensome and costly protocol. Rollout of the PDS is expected in the U.S. in 2021 and beyond the U.S. in 2022. More information.
Apellis reported in August 2017 that injections of APL-2 demonstrated a significant slowing of the progression of dry age-related macular degeneration (atrophic AMD). Then, in October 2020, a phase 2 analysis found that the monthly treatment reduced the rate of progression to geographic atrophy (GA) by 39 percent in areas of the retina outside of existing GA lesions. Top-line results are expected in the third quarter of 2021. More information.
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