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Efficacy, Safety of Aflibercept 8 mg Proven for Treatment of AMD
08 Apr 2025 17:26 GMT
… Food and Drug Administration in August 2023. The treatment is the … the PULSAR and PHOTON trials.3
“Aflibercept 8 mg … Lanzetta, MD, department of medicine-ophthalmology, University of Udine, … (2 and 8 mg), ranibizumab, brolucizumab, faricimab, and bevacizumab …
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Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD
08 Apr 2025 12:45 GMT
… S. Food and Drug Administration (FDA) has acknowledged receipt … versus ranibizumab in a 12 week study of treatment … Therapeutics’ ability to remediate or otherwise resolve deficiencies … pharmaceutical product candidates, risks of conducting clinical trials …
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Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD
03 Apr 2025 17:18 GMT
… vision. The FDA approved the anti-VEGF agents ranibizumab (Lucentis) … ranibizumab biosimilar that was developed by Teva Pharmaceuticals for the treatment … of nAMD to the medical retina department. The study … 53% reduction in average drug costs after 5 years …
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Sponsor Pulls Plug on Trials of Add-On AMD Treatment
03 Apr 2025 11:13 GMT
… two phase 3 clinical trials of an add-on … every 8 weeks. The ranibizumab trial, known as ShORe, compared … a year of treatment, whereas those on ranibizumab only experienced an … and Regeneron Pharmaceuticals.
Richard Mark Kirkner is a medical journalist based …
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Opthea Announces Termination of ShORe and COAST Trials of Sozinibercept
03 Apr 2025 03:36 GMT
… OPT-302 in combination with Ranibizumab (ShORe) trials, as well as ceasing … by the US Food and Drug Administration, who highlighted sozinibercept’s … AMD treatment. Opthea quickly enacted the initial COAST Phase 3 trial; however …
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Opthea discontinues COAST and ShORe trials in wet AMD
31 Mar 2025 18:12 GMT
… 0.5 mg ranibizumab monotherapy.
Results from the trial showed that participants … their contributions in investigating new treatments for wet AMD.”
As previously … decision to discontinue wet AMD trials. Opthea. Published March 31, 2025 …
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Opthea Announces Decision to Discontinue Wet AMD Trials
31 Mar 2025 04:01 GMT
… and ShORe trials Opthea continues to consider impact of negative trial results … , versus 0.5 mg ranibizumab monotherapy. The trial did not meet its … , production, marketing and sale of drug treatments, regulatory risk and potential loss …
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CompaRative Safety Analysis of Innovator and BioSimilar Ranibizumab in Chorioretinal Vascular Diseases - The CRsIBS Study
28 Mar 2025 06:11 GMT
… India) and biosimilar ranibizumab (Razumab™: Intas pharmaceuticals, Gujarat, India … extracted from electronic medical records of eligible … other than the drugs being compared) within … Degeneration Treatments Trials. Ranibizumab and bevacizumab for treatment of …
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Sozinibercept for Wet AMD Misses Primary Endpoint in Phase 3 COAST Trial
25 Mar 2025 20:32 GMT
… The US Food and Drug Administration granted Fast … acknowledging the significant unmet medical need that sozinibercept could … pivotal Phase 3 clinical trials (COAST and ShORe) … treatment-naive patients with wet AMD. The trial is set to evaluate ranibizumab …
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Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars
19 Mar 2025 21:44 GMT
… ranibizumab biosimilars is safe and effective for patients receiving treatment … knowledge, no switching trial has evaluated using … safety, no drug-related ocular or … treatment of diabetic macular edema and vision-threatening diabetic retinopathy among Medicare …