Ophthalmology updates from around the globe

Apellis Pharmaceuticals receives approval of pegcetacoplan (Syfovre) for treatment of geographic atrophy in Australia

Earlier this week, Apellis Pharmaceuticals announced the Therapeutic Goods Administration (TGA) in Australia approved pegcetacoplan (Syfovre) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

This approval of Syfovre makes it the first and only approved treatment for GA in Australia.

The Australian approval was based on results from the company’s Phase 3 OAKS and DERBY studies at 24 months in which treatment with both every-other-month and monthly Syfovre was shown to slow GA progression and showed a generally well-tolerated safety profile.

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AI Optics’ portable Sentinel Camera gains FDA 510(k) clearance

AI Optics , an AI-focused medical device company, has received FDA 510(k) clearance for its?Sentinel Camera, a handheld retinal imaging system.

The Sentinel Camera aims to address critical gaps in retinal disease screening by offering a portable device that captures high-quality images that require no dilation of the eye. According to the company, this eliminates the need for some patients to visit an eye specialist’s office. Additionally, the Sentinel Camera supports DICOM-compliant image formats, allowing integration with Electronic Health Record (EHR) systems.

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Vyluma announces NMPA of China accepts drug application of NVK002 (low-dose atropine 0.01%) for myopia progression in children

Vyluma announced the National Medical Products Administration (NMPA) of China has accepted the drug application from Zhaoke Ophthalmology for its lead compound, NVK002 (low-dose atropine 0.01%) as a potential treatment for myopia progression in children.

NVK002 was developed by Vyluma and licensed to Zhaoke in 2020. Under the terms of the agreement, Zhaoke develops and obtains regulatory approval for NVK-002 in Greater China, South Korea and the Southeast Asian territories. In those areas Zhaoke will also manufacture, launch, distribute, and support the commercialization of the NVK002.

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