Jordana Joy

The FDA comments in the CRL relate to proposed labelling language, not safety, Astellas said in a press release.

The study is now expected to be fully enrolled with all 300 patients randomized by the end of 2024.

The company reported that statistically significant data was found supporting ANX007’s ability to provide vision loss protection in patients with geographic atrophy.

While it fell short of the primary endpoint of improvement of non-proliferative diabetic retinopathy (NPDR) of at least 2 Diabetic Retinopathy Severity Scale (DRSS) levels as of week 36, DURAVYU did demonstrate stable or improved disease severity with reduced rates of NPDR in 9 months.

The diagnostic screening technology is able to diagnose diabetic retinopathy by using 1 image taken of each eye with over 99% imageability.

The American subsidiary of the German ophthalmic diagnostic device designer announced in a news release that its OCULUS Easyfield VR™ is now available in the US ophthalmic market

A new case-control study found that older people ages 70 and older living in South Korea’s urban areas were at a significantly higher risk for developing incident exudative age-related macular degeneration.