OpZira™, Inc. Completes Stage II Audit, Advancing AdaptDx Pro® Toward European CE Marking

MIDDLETOWN, Pa.--(BUSINESS WIRE)--OpZira™, Inc., an ophthalmic medical device company advancing technologies for the detection and monitoring of ocular disease, today announced its subsidiary, AdaptDx, Inc., has completed its Stage II audit at the company's Lighthouse medical device manufacturing facility. The audit represents an important step in the ISO certification process and supports OpZira's plans to pursue CE marking for AdaptDx Pro^® in the European Union in 2027.

AdaptDx Pro is a portable dark adaptometer that objectively measures rod-mediated dark adaptation (RMDA) function. The AdaptDx Pro is available for sale in the US as a class I device. The core technology measures the ability to visually adapt to low levels of light, an important indicator of retinal function that may be impaired in patients with early retinal disease. Night vision problems, including difficulty driving at night and reading in low light, are typical symptoms of dark adaptation dysfunction.

Dark adaptation technology has been validated in over 42 peer-reviewed papers. Recently, multiple publication from the prospective, three-year ALLSTAR 2 studies demonstrated RMDA’s value as a biomarker in early dry AMD patients. Building on its portfolio of ophthalmic innovation, the company is focused on expanding access to advanced technologies that support clinical decision-making and patient care.

“Completion of the Stage II audit marks an important step in our strategy to expand the global availability of AdaptDx Pro,” said Clark Tedford, Ph.D., 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.”

About OpZira

OpZira, Inc. is a forward-thinking ophthalmic medical device company founded on a legacy of research excellence. The company delivers innovative technologies designed to enhance the detection and monitoring of ocular disease, empowering clinicians with advanced diagnostic tools. OpZira’s creation follows Alcon’s acquisition of LumiThera and its Valeda^® Light Delivery System, the first and only FDA-authorized treatment for dry age-related macular degeneration (AMD). For more information, visit OpZira.com.

AdaptDx Pro Indications for Use: The AdaptDx Pro is sold as a Class I device in the U.S. and intended to measure the time for retinal adaptation after exposure to an adapting light and is not intended to diagnose, detect, or screen for any specific ocular disease.

Disclaimer: AdaptDx Pro has not been approved by FDA for use in detection or diagnosis of any specific ocular disease (such as AMD). The safety and effectiveness of AdaptDx Pro for this use has not been established.