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Light Therapy Might Help Ease 'dry' Form Of Macular Degeneration
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Clearside's CLS-AX Shows Promise In Treatment Of Wet Age-related Macular Degeneration
The Latest
The ODYSSEY study is a recent Phase 2b clinical trial which investigated the use of Clearside's axitinib injectable suspension (CLS-AX) in the treatment of wet age-related macular degeneration. The study followed a 2:1 randomization to assess the use of CLS-AX in 40 patients compared to 20 patients receiving standard treatment. The study achieved its primary outcome of improvement in visual acuity, as patients receiving CLS-AX had stable visual acuity for six months. Secondary outcomes, including changes in ocular anatomy and the need for supplemental treatment, were also met. 90% of patients did not require additional treatment at four months, and patients maintained stable retinal thickness at six months.
Physician's Perspective
Age-related macular degeneration (AMD) is a common condition and a leading cause of vision loss. It occurs when a part of the retina, called the macula, is damaged. This causes a loss of central vision at near and far distances. There are two types of AMD: dry AMD is caused by protein clumping, and thinning of the macula with age, while wet AMD is caused by abnormal blood vessel growth and leakage that damages the retina.
Current treatments for wet AMD involve laser therapy against abnormal blood vessels or medications that reduce the number of blood vessels and the amount of leakage. These medications are called anti-VEGF drugs because they inhibit vascular endothelial growth factor (VEGF), which normally stimulates blood vessel formation. CLS-AX is a novel treatment that blocks three VEGF receptors to provide long-lasting benefits. Compared to existing treatments that require frequent, lifelong injections, CLS-AX may be longer-acting and reduce treatment burden associated with AMD.
Molecular Targets
CLS-AX is an injectable tyrosine kinase inhibitor of VEGF receptors. It binds to a region of the VEGF receptors called the tyrosine kinase domain to block cell signaling. As previously mentioned, VEGF promotes new blood vessel formation, and thus blocking VEGF receptors prevents vessel growth and reduces damage to the macula. Additionally, CLS-AX is administered in a specific way that delivers the drug to the diseased area at the back of the eye. This delivery method, called suprachoroidal injection, ensure higher levels of the drug reach the retina and macula.
Company History
This treatment was developed by Clearside Biomedical. Clearside specializes in developing suprachoroidal injection therapies to treat many different ocular diseases. Their patented SCS Microinjector is the only FDA approved product to administer drugs to the suprachoroidal space. Clearside is also known for Xipere, a suprachoroidal steroid injection approved to treat macular edema. They are also exploring the use of gene therapies to treat wet AMD, with their product ABBV-RGX-314 currently in Phase 2a clinical trials.
Further reading: https://www.Sciencedirect.Com/science/article/pii/S2666914524001222
©2024 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.
Biosimilar Aflibercept P041 As Effective, Safe As Originator In NAMD
Biosimilar aflibercept (P041) demonstrated comparable safety and efficacy to the originator aflibercept (Eylea) in treating patients with retinal conditions like neovascular age-related macular degeneration (nAMD).
Biosimilar aflibercept (P041) demonstrated comparable safety and efficacy to the originator aflibercept (Eylea) in treating patients with retinal conditions like neovascular age-related macular degeneration (nAMD).Image Credit: Yakobchuk Olena - stock.Adobe.Com
Biosimilar aflibercept (P041) exhibited similar effectiveness and safety as originator aflibercept (Eylea) in retinal conditions like neovascular age-related macular degeneration (nAMD), according to a study published in the American Academy of Ophthalmology.1
Both patients with AMD and nAMD have retinal conditions caused by choroidal neovascularization that impairs vision. Vascular endothelial growth factor (VEGF) is heavily responsible in active intraocular neovascularization and preventing VEGF can treat neovascular disease.
The reference product received FDA approval for patients with nAMD in November 2011 following the positive results from the VIEW 1 and VIEW 2 studies.2 The first 2 biosimilars referencing aflibercept came a little over 10 years later, with the approval of aflibercept-yszy (Opuviz) and aflibercept-jbvf (Yesafili) in the latter half of May 2024.3
Majority of the population with AMD or nAMD is elderly, thus biosimilar options offer accessible treatment that is priced lower than the reference products, significantly beneficial for those living on fixed incomes after reaching retirement.1
"The aim of this trial was to assess the efficacy, safety, and immunogenicity of P041 in comparison with the reference aflibercept over 52 weeks," stated the study authors.
Participants were enrolled in a phase 3 randomized, double-masked active control trial over a 52-week duration across multiple centers. Patients were randomly assigned either biosimilar aflibercept (P041) or the reference product (Eylea) via intravitreal injections. Both groups received treatment every 4 weeks with 3 loading doses then every 8 weeks until week 48.
The primary outcome was to evaluate the noninferiority of intravitreal P041 compared with originator aflibercept at week 52. The secondary outcomes included the changes in visual acuity and retinal thickness, safety evaluation, and immunogenicity throughout the study.
The study included 1 individual eye from 168 patients who were each randomly assigned to a study arm, both groups evenly split into 84 participants each (P041, originator aflibercept) with an average age of 68 years. Of the 168 patients, there were 145 who completed the study for the entire 52 weeks (P041, n = 72; aflibercept, n = 73).
By week 52, 94.44% of patients in the P041 group and 94.52% in the aflibercept group maintained their vision from baseline. No significant differences were identified between the 2 groups (difference, –0.0008; 95% CI, –0.074-0.074; P = .98).
Both groups demonstrated a percentage of 93.98% of patients who maintained vision (difference, 0; 95% CI, –0.072-0.072; P = 1). The predefined noninferiority margin was lower than the percentage difference.
Secondary outcomes found no significant differences between the 2 groups and best corrected visual acuity improved in both arms as well (P = .96). Across the P041 biosimilar arm and the originator aflibercept group, all differences were considered nonsignificant (all P > .05). Immunogenicity ruled efficacy date proved the treatment could maintain visual acuity, change central subfield thickness, and achieve a dry macula by week 52.
Adverse events (AEs) were present among 44 patients in the aflibercept originator group and 47 patients in the P041 biosimilar group. Injection site irritation and rhinorrhea were the most reported ocular AE and the most reported nonocular AE, respectively, for both groups.
The COVID-19 pandemic disrupted the study, resulting in limited visitations and follow-up schedules for some patients. Data was also reviewed by a research coordinator but the evaluation of the images in an image reading center may improve the validity of data.
"This phase 3 clinical trial showed P041 is noninferior to aflibercept in terms of maintaining vision," concluded the study authors. "Other efficacy and safety outcomes were also similar between the 2 products through 52 weeks of the study."
References
1. Karkhaneh R, Faghihi H, Riazi-Esfahani H, et al. Evaluating the efficacy and safety of aflibercept biosimilar (P041) compared with originator product in patients with neovascular age-related macular degeneration. Ophthalmology Retina. 2024;8(8):744-753. Doi:10.1016/j.Oret.2024.02.012
2. Regeneron announces Eylea (aflibercept ophthalmic solution) receives unanimous recommendation for approval for treatment of wet AMD from FDA advisory committee. Drugs.Com. November 18, 2011. Accessed October 28, 2024. Https://www.Drugs.Com/nda/eylea_110617.Html
3. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars®. May 20, 2024. Accessed October 28, 2024. Https://www.Centerforbiosimilars.Com/view/fda-approves-first-eylea-biosimilars
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