A new drug called VUITY™ (pilocarpine hydrochloride ophthalmic solution) has recently gained attention as an eye drop that can improve near (close up) vision in individuals over 40. It does not, however, change the condition of the retina. The drug, made by Allergan, works as advertised, but it should not be expected to treat age-related macular degeneration (AMD).
Vuity™ is available by prescription to treat only presbyopia. Presbyopia is common in aging eyes, resulting in stiffening of the eye’s lens and making natural focusing difficult. Reading glasses can help, but eyes with central vision loss from AMD will not benefit from either glasses or Vuity™. Vuity™ works by lessening the size of the eye’s pupil, making it easier to focus on near objects or text. This creates a kind of pinhole effect, which patients may remember as one way doctors test visual acuity. This effect may also be achieved by peering through a pinhole in an index card.
If in doubt, patients should consult with their doctors for advice about whether Vuity™ will be appropriate for them.
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
Prevent Blindness has launched its first-ever Geographic Atrophy (GA) Awareness Week from December 6-12, 2021. GA is an advanced form of dry age-related macular degeneration (commonly referred to as AMD) which leads to vision loss in the center of one’s vision. Geographic atrophy results in areas of damaged tissue causing central blind spots. It is estimated that 1 million people in the United States have GA.
Prevent Blindness has created a variety of new resources on geographic atrophy, including a downloadable fact sheet, and a dedicated webpage. A series of shareable social media graphics is also available and will be posted by Prevent Blindness on its various social media channels throughout the week. Development of these new resources was sponsored by Apellis Pharmaceuticals, Inc.