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Week in review: FDA lawsuit, eye worms, Apple of my eye

American Academy of Ophthalmology News Nov 18, 2019

A weekly roundup of ophthalmic news from around the web.

Regenxbio is suing the FDA over clinical holds on two trials involving the company's gene therapy, RGX-314, for wet AMD. The lawsuit alleges that the agency has “rebuffed” repeated attempts for an explanation, and has caused Regenxbio to suffer “reputational, economic, and competitive injury.” The timing for the long-shot move is curious, considering the FDA had set a November 15 due date for delivering a written basis for one hold. Stay tuned for how this plays out in court. FDA Law Blog

A novel pupil-modulating eye drop is posting promising topline results, according to Ocuphire Pharma. Nyxol, a proprietary formulation of the approved alpha-1 and alpha-2 inhibitor phentolamine mesylate, reversed pharmacologically induced mydriasis within 2 hours and reduced pupil diameter sooner than placebo. The drug will advance to phase 3 trials for three indications: moderate to severe night vision disturbance, mydriasis reversal and presbyopia reversal. Ocuphire Pharma

A woman from Nebraska is the second known human to be infected by cattle eye worms, according to a report in Clinical Infectious Diseases. A hiker discovered four worms in her eye after running through a swarm of flies a month earlier. The roundworm Thelazia gulosa was thought to infect only cows, but this is the second documented case since an Oregon woman pulled 14 live worms from her eye in 2016. Need more? Researchers also discovered eggs in one of the worms, suggesting humans may be a suitable host for propagation. SF Gate, Clinical Infectious Diseases

Apple is setting their sights on a new market, literally, by entering the augmented reality (AR) realm. A new report suggests the company will release an AR headset in 2022, with a focus on gaming, watching video and virtual meetings. Apple’s headset will supposedly be a slimmer version of Facebook’s Oculus Quest, with AR and VR functions, and external cameras to map surroundings onto a high-resolution display. The Verge, Bloomberg

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