Rising use of intravitreal treatments for age-related macular degeneration.
Age-related macular degeneration (AMD) is a prevalent cause of blindness, with an expected rise in affected individuals globally. Neovascular AMD (nAMD) is one of the severe forms of the disease, leading to vision loss. In 2006, the FDA approved intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs for nAMD treatment, marking a significant advancement in managing the condition. These injections brought about substantial visual acuity improvements, surpassing traditional therapies like laser treatment.
However, the demanding regimen of frequent injections, often on a monthly basis, posed challenges for patients, affecting treatment adherence and real-world effectiveness. To address this issue, researchers focused on developing more durable drugs that could extend the intervals between injections, aiming to enhance compliance and prolong therapeutic effects. One such approach involved reformulating the FDA-approved drug aflibercept from 2 mg to a higher concentration of 8 mg to explore sustained therapeutic benefits over longer intervals.
The PULSAR study, conducted by Jeffrey S Heier and colleagues, was a rigorous clinical trial involving 1009 participants across 27 countries. The study compared three dosing regimens of aflibercept: 8 mg every 12 weeks, 8 mg every 16 weeks, and 2 mg every 8 weeks (control group). The primary outcome assessed was the change in best-corrected visual acuity from baseline to week 48. Notably, the 8 mg doses administered at 12 and 16-week intervals demonstrated non-inferior gains in visual acuity compared to the 2 mg control group. The study successfully met its primary endpoint at 48 weeks, indicating the potential of the higher concentration aflibercept to improve the management of nAMD by allowing longer intervals between injections.
The safety profile of the 8 mg aflibercept was also evaluated and found to be comparable to lower concentration formulations, with no significant increase in intraocular pressures or notable side effects. The approval of the 8 mg aflibercept by both the US FDA and the European Commission underscored its efficacy and safety in treating nAMD and other retinovascular diseases, marking a significant milestone in the management of this sight-threatening condition.
The study results suggest that the 8 mg aflibercept formulation could offer a promising treatment option for nAMD patients, potentially reducing the treatment burden on healthcare providers, patients, and their families. The findings of the PULSAR study support the efficacy of the higher concentration drug in maintaining visual acuity gains, reducing disease activity, and lesion size over the treatment period. While the study participants demonstrated good retention rates, further research to evaluate the long-term effects of the 8 mg aflibercept up to 96 weeks will be crucial in understanding its sustained benefits.
Post-approval surveillance and ongoing research efforts are essential to monitor any emerging adverse effects and optimize treatment strategies for nAMD. Overall, the development of longer-sustaining intravitreal drugs like the 8 mg aflibercept represents a significant advancement in combating AMD-related vision loss on a global scale, offering hope for improved outcomes and quality of life for affected individuals.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00229-0/fulltext
However, the demanding regimen of frequent injections, often on a monthly basis, posed challenges for patients, affecting treatment adherence and real-world effectiveness. To address this issue, researchers focused on developing more durable drugs that could extend the intervals between injections, aiming to enhance compliance and prolong therapeutic effects. One such approach involved reformulating the FDA-approved drug aflibercept from 2 mg to a higher concentration of 8 mg to explore sustained therapeutic benefits over longer intervals.
The PULSAR study, conducted by Jeffrey S Heier and colleagues, was a rigorous clinical trial involving 1009 participants across 27 countries. The study compared three dosing regimens of aflibercept: 8 mg every 12 weeks, 8 mg every 16 weeks, and 2 mg every 8 weeks (control group). The primary outcome assessed was the change in best-corrected visual acuity from baseline to week 48. Notably, the 8 mg doses administered at 12 and 16-week intervals demonstrated non-inferior gains in visual acuity compared to the 2 mg control group. The study successfully met its primary endpoint at 48 weeks, indicating the potential of the higher concentration aflibercept to improve the management of nAMD by allowing longer intervals between injections.
The safety profile of the 8 mg aflibercept was also evaluated and found to be comparable to lower concentration formulations, with no significant increase in intraocular pressures or notable side effects. The approval of the 8 mg aflibercept by both the US FDA and the European Commission underscored its efficacy and safety in treating nAMD and other retinovascular diseases, marking a significant milestone in the management of this sight-threatening condition.
The study results suggest that the 8 mg aflibercept formulation could offer a promising treatment option for nAMD patients, potentially reducing the treatment burden on healthcare providers, patients, and their families. The findings of the PULSAR study support the efficacy of the higher concentration drug in maintaining visual acuity gains, reducing disease activity, and lesion size over the treatment period. While the study participants demonstrated good retention rates, further research to evaluate the long-term effects of the 8 mg aflibercept up to 96 weeks will be crucial in understanding its sustained benefits.
Post-approval surveillance and ongoing research efforts are essential to monitor any emerging adverse effects and optimize treatment strategies for nAMD. Overall, the development of longer-sustaining intravitreal drugs like the 8 mg aflibercept represents a significant advancement in combating AMD-related vision loss on a global scale, offering hope for improved outcomes and quality of life for affected individuals.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00229-0/fulltext
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