Key Takeaways

  • OpZira's subsidiary AdaptDx completed its Stage II audit, advancing ISO certification efforts and plans for European CE marking in 2027

  • AdaptDx Pro measures rod-mediated dark adaptation, a functional biomarker associated with early retinal dysfunction and dry AMD

  • Clinical research, including the ALLSTAR 2 studies, supports the potential role of RMDA testing in detecting and monitoring retinal disease

OpZira announced that its subsidiary, AdaptDx, has completed its Stage II audit at the company's Lighthouse medical device manufacturing facility, marking a step toward ISO certification and planned CE marking of AdaptDx Pro in the European Union in 2027.

AdaptDx Pro is a portable dark adaptometer designed to objectively measure rod-mediated dark adaptation (RMDA), a functional indicator of retinal health. The device is currently available in the United States as a Class I medical device.

RMDA testing assesses the eye's ability to adapt to low-light conditions, a function that may be impaired in patients with early retinal disease. Dark adaptation dysfunction can manifest as difficulty driving at night or reading in dim lighting.

According to OpZira, dark adaptation technology has been evaluated in more than 42 peer-reviewed publications. Recent findings from the prospective, 3-year ALLSTAR 2 studies have further demonstrated the potential value of RMDA as a biomarker in patients with early dry age-related macular degeneration (AMD).

“Completion of the Stage II audit marks an important step in our strategy to expand the global availability of AdaptDx Pro,” said Clark Tedford, PhD, President and CEO of OpZira. “Our AdaptDx Pro technology provides an objective, quantitative biomarker of retinal dysfunction and with the approval of early treatments, the importance of early detection and monitoring become critically important to guide the physicians.”

The company said its certification efforts are intended to support broader international access to AdaptDx Pro and its use in clinical decision-making and disease monitoring.

OpZira was established following Alcon's acquisition of LumiThera and its Valeda Light Delivery System, an FDA-authorized treatment for dry AMD.