IDx has announced that the U.S. Food and Drug Administration has granted the company’s de novo request to market IDx-DR, an AI-based diagnostic system for the autonomous detection of diabetic retinopathy. This is the first autonomous, AI-based diagnostic system authorized for commercialization by the FDA.
IDx says that the IDx-DR can be used to provide immediate, reliable screening for diabetic retinopathy, including macular edema, during a routine office visit in a primary care setting. The exam is performed in minutes and produces a diagnostic interpretation and associated report, including care instructions that are aligned with the American Academy of Ophthalmology’s preferred practice pattern for diabetic retinopathy.
For more information on IDx-DR and its availability, visit eyediagnosis.net.
Bausch + Lomb’s Lumify Now Available
In early May, Bausch + Lomb announced the launch of Lumify (brimonidine tartrate ophthalmic solution 0.025%) in the United States. Lumify is the first over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of eye redness.
Researchers conducted six clinical studies in more than 600 patients to evaluate the safety and efficacy of Lumify, including studies with both pediatric and geriatric subjects. Bausch + Lomb says that the strong efficacy and safety profile of Lumify includes not only significant redness reduction for up to eight hours, but a low risk of allergic reactions among all patient groups.
For more information on Lumify, visit Bausch.com.
Alcon’s Systane Complete
Alcon recently announced the addition of Systane Complete, a new formula designed to provide relief for dry eye, to its Systane family of dry-eye drops. Alcon says that Systane Complete is an ideal first-line treatment option for people who suffer from evaporative, aqueous-tear-deficient or mixed dry eye.
Alcon says Systane Complete uses intelligent moisture and lipid delivery to enhance transmission of the active ingredient across the surface of the eye to stabilize the tear film. It also comes equipped with nano-droplet technology that allows for fast-acting hydration, tear evaporation protection and long-lasting relief for a patient’s eyes, the company says. Systane Complete drops include the active demulcent propylene glycol, which spreads across the surface of the eye, Alcon adds.
For more information on this new addition to the Systane family, visit alcon.com.
New Lucentis Approval
In late March, Genentech announced that the FDA approved the Lucentis (ranibizumab injection) 0.3-mg prefilled syringe as a method of administering the medicine used in treating all forms of diabetic retinopathy, in people with or without diabetic macular edema. The Lucentis 0.3-mg PFS is now the first syringe prefilled with an antivascular endothelial growth factor agent FDA-approved to treat both diabetic retinopathy and DME.
The syringe is packaged in a single-use sterile sealed tray, allowing physicians to eliminate several steps in the preparation and administration process. Genentech says that with the Lucentis PFS, physicians snap off the syringe cap, attach the injection needle to the syringe and adjust the dose prior to administration. It’s expected to be available in the second quarter of 2018, the company says.
For more on Lucentis, visit gene.com.