Ophthalmology Overview: Bevacizumab for Wet AMD, AI in Retinal Disease Management, and More

Highlighting the latest ophthalmology-related news reported across MJH Life Sciences™.

Ophthalmic Formulation of Bevacizumab Seeks BLA Approval in Wet AMD

In what would become the first ophthalmic formulation of bevacizumab approved to treat retinal conditions, Outlook Therapeutics presented clinical progress of bevacizumab-vikg, a full-length, humanized anti-vascular endothelial growth factor (VEGF) recombinant monoclonal antibody (mAb) for the treatment of wet age-related macular degeneration (wet AMD).

Exhibiting positive topline 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 investigational therapy would provide a new therapeutic option for those with the condition who often are given unapproved repackaged IV bevacizumab, which is associated with potential lack of sterility and inconsistent potency.

As reported by Modern Retina^TM, bevacizumab-vikg is currently under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases.

Applying Artificial Intelligence (AI) to Retinal Disease Management

In an article by Modern Retina^TM, a Q&A with Konstantinos Balaskas, MB BS, MD, FEBO, MRCOPHTH, a retinal expert at Moorfields Eye Hospital and director of the Moorfields Ophthalmic Reading Centre and AI Analytics Hub, discussed the opportunities and hurdles present for patients and health care professionals in leveraging AI for retinal disease management.

Speaking on how AI has been applied for retinal diseases, Balaskas highlights that the ophthalmology field has become a pioneer in implementing AI in medicine through the use of deep learning, a process by which software programs learn to perform certain tasks by processing large quantities of data. Through imaging testing, he said that results have provided the material to train, test, and apply AI decision support systems, which could prove vital in improving access to care for conditions that require early detection and could lead to vision loss, such as AMD and diabetic retinopathy.

Once validated and having gained regulatory approval as medical devices, Balaskas notes that AI decision support tools could assist health practitioners in communities to diagnose diseases early. Currently, AI decision support tools exist for some retinal diseases, including diabetic retinopathy, with other indications for conditions like AMD in advanced stages of development.

FDA Accepts Resubmitted NDA for Treatment of Macular Edema Associated With Uveitis

As reported by Ophthalmology Times^®, the FDA approved the resubmitted New Drug Application for Clearside Biomedical Inc. and Bausch + Lomb’s riamcinolone acetonide suprachoroidal injectable suspension, sold as Xipere, for the treatment of macular edema associated with uveitis.

Designed for suprachoroidal administration through Clearside’s proprietary SCS microinjector, the investigational therapy would be the first therapy available, pending FDA approval, to utilize the suprachoroidal space for patients with macular edema associated with uveitis, the leading cause of vision loss in people with uveitis.

The filing was identified as a Class 2 resubmission by the FDA, who set a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021.