In what would become the first ophthalmic formulation of bevacizumab approved for treating retinal conditions, Outlook Therapeutics presented the clinical progress of bevacizumab-vikg, a fully humanized recombinant anti-vascular endothelial (VEGF) monoclonal antibody (mAb) for the treatment of age-related wet macular degeneration (wet AMD).
Showing positive results in 2 of the 3 clinical trials that will form the data submission to the FDA for a new Biologics License Application (BLA) in the treatment of wet AMD, the experimental therapy would offer a new treatment option for people with the disease. who often receive unapproved repackaged IV bevacizumab, which is associated with a potential lack of sterility and inconsistent potency.
As reported by Modern retinaMT, bevacizumab-vikg is currently in development for administration as an intravitreal injection for the treatment of wet AMD and other diseases of the retina.
Application of artificial intelligence (AI) to the management of retinal diseases
In an article by Modern retinaMT, a question-and-answer session with Konstantinos Balaskas, MB BS, MD, FEBO, MRCOPHTH, retina expert at Moorfields Eye Hospital and director of the Moorfields Ophthalmic Reading Center and the AI Analytics Hub, discussed the opportunities and obstacles faced by patients and healthcare professionals to leverage AI for retinal disease management.
Speaking on how AI has been applied to diseases of the retina, Balaskas points out that the field of ophthalmology has become a pioneer in the implementation of AI in medicine through deep learning. , a process by which software learns to perform certain tasks by processing large amounts of data. . Through imaging tests, he said the results have provided the material needed to train, test and apply AI decision support systems, which could prove critical to improving access to care. for conditions that require early detection and can lead to vision loss, such as AMD diabetic retinopathy.
Once validated and having obtained regulatory approval as medical devices, Balaskas notes that AI decision support tools could help health practitioners in communities diagnose illnesses at an early stage. Currently, AI decision support tools exist for certain retinal diseases, including diabetic retinopathy, with other indications for conditions such as AMD in later stages of development.
FDA accepts new NDA for treatment of macular edema associated with uveitis
As reported by Ophthalmology schedules®, the FDA has approved the new drug application for Clearside Biomedical Inc. and Bausch + Lomb’s suprachoroidal injection of riamcinolone acetonide, sold as Xipere, for the treatment of macular edema associated with uveitis .
Designed for suprachoroidal delivery via Clearside’s proprietary SCS microinjector, the investigational therapy would be the first therapy available, pending FDA approval, to use the suprachoroidal space for patients with macular edema associated with it. uveitis, the main cause of vision loss in people with uveitis.
The filing was identified as a new Class 2 submission by the FDA, which set an action date under the Prescription Drug User Fees Act (PDUFA) for October 30, 2021.