New treatment option opens avenues in geographic atrophy
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An intravitreal injection is the most common procedure performed in ophthalmology, with 8 million performed per year in the U.S. alone.
An intravitreal injection is also the most common procedure performed by most ophthalmologists in training during their residency, and many choose to make this procedure a part of their practice after training is completed. While fellowship-trained retina specialists perform most intravitreal injections today, recent studies suggest as many as one in three are performed by a comprehensive ophthalmologist. I expect this to grow to 50% over the next decade. The recent approval of Syfovre (pegcetacoplan injection, Apellis Pharmaceuticals) for the treatment of geographic atrophy (GA) will further expand the indications for an intravitreal injection.
The prevalence of GA, the most severe form of dry age-related macular degeneration, is similar to the prevalence of neovascular AMD, about 1 million people in the U.S. and 5 million worldwide. GA is the most severe form of dry AMD. It results in the irreversible loss of photoreceptors, retinal pigment epithelium and choriocapillaris with a slow but progressive reduction in visual acuity and patient function. Many patients with perifoveal GA can still read the 20/20 line on a visual acuity chart, but they have significantly reduced visual function. A common complaint is difficulty reading, and this can be evaluated by testing reading speed. Risk factors for progression include age, oxidative stress, and perhaps inflammation and ischemia. The complement cascade is implicated in GA progression, and Syfovre works by downregulating the complement cascade of inflammation. Cessation of smoking, improvement of blood flow and antioxidant vitamin therapy may also be beneficial.
Diagnosis is through a careful fundus examination, OCT, fundus autofluorescence and fluorescein angiography. It will now be even more important for every eye care professional to screen their patients carefully for GA. OCT will be an important test as some GA patients also have neovascular AMD and deserve referral for anti-VEGF therapy. All patients with GA can be counseled to cease smoking, offered antioxidant vitamin therapy, and informed regarding the new opportunity for therapy with Syfovre.
Referral to an ophthalmologist skilled in the art and science of intravitreal drug therapy will be appropriate for interested patients. Many patients will need to be comanaged by more than one eye care professional, and the side effects of GA intravitreal therapy will be like the side effects of other intravitreal injections: pain, elevated IOP, inflammation and the feared endophthalmitis. Referral to an expert in low vision aids and occupational therapy for visual impairment can help many patients as their GA advances.
The improvement in patient quality of life, significant treatment burden and financial impact associated with the approval of anti-VEGF therapy for neovascular AMD have been enormous. Anti-VEGF therapy results in a rapid and significant improvement in visual acuity and function for most neovascular AMD patients treated. Syfovre therapy will be different, providing a more subtle benefit by reducing the rate of progression of GA. Because treatment effects will be less immediate and easy to recognize, the number of patients opting for intravitreal therapy for GA is likely to be lower than we have experienced for neovascular AMD. However, every patient with GA deserves to be made aware of this new treatment option and its potential benefits, risks and alternatives. We can expect other drugs, including avacincaptad pegol from Iveric Bio, to be approved for the treatment of GA in the future.
Next, formulation improvements and extended-release drug delivery advances that lengthen the durability of each intravitreal injection and reduce the costs and treatment burden will evolve. An injection once every 4 to 6 months, whether it be for neovascular AMD or GA, is much more palatable for a patient than a monthly injection. Treat-and-extend therapeutic protocols for GA are also likely to be employed.
We will all be participating in the creation of yet another new therapeutic vertical in eye care, much to the benefit of our patients, we providers and industry. We and our patients are fortunate our specialty still supports the investment of human and financial capital required to support innovation.
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