Some PMA filings manage to scrape by at U.S. FDA advisory hearings, but the application for the Visability device by Refocus Group Inc. was not one of those. The panel voted 15-1 that the benefits of the device for presbyopia did not outweigh the risks, leaving the sponsor with a fundamental question about the viability of a technology that has been under development for more than 20 years.

Visible Genomics has launched a set of noninvasive genetic tests aimed at assessing the overall risk of developing age-related macular degeneration (AMD) or progressing with the disease. AMD is a common condition that affects the part of the eye called the macula. It typically blurs the central vision used in tasks like reading and driving and develops around age 50.

LONDON – Gyroscope Therapeutics Ltd. is poised to move the field of ocular gene therapy on from the treatment of inherited rare diseases to address more common eye conditions, after receiving FDA 510(k) clearance for its Orbit SDS subretinal delivery device.

Alcon AG released second-quarter results Aug. 18, reporting worldwide sales of $1.2 billion. That figure represented a decrease of 36%, or 34% on a constant currency basis, vs. the same period last year as COVID-19 hit all business categories. As Wells Fargo’s Larry Biegelsen noted, the Geneva-based company, which held its call Aug. 19, saw net loss per share coming in worse than expected due to higher selling, general and administrative expenses.

HONG KONG – China’s Arctic Vision (Shanghai) Biotechnology Co. Ltd. has entered an exclusive deal with New York’s Eyenovia Inc. to develop and commercialize ophthalmic formulations that are delivered using the latter’s first-in-class microdosing spray technology. Under the deal, Arctic Vision will commercialize Eyenovia’s Micropine and Microline formulations in Greater China and South Korea in exchange for $45.75 million in upfront payments and additional milestone and royalty payments.

Bausch Health Companies Inc. has long been considering strategic options for its eye health business. But now that it has paid down $8 billion in debt and divested $4 billion in non-core assets, it expects that the time is now right to spin out the eye health business as a separate publicly traded entity.

People with diabetes are at risk of developing diabetic retinopathy (DR), an eye condition that can cause vision loss and blindness. However, early detection and treatment can slow its progress. To that end, the Food and Drug Administration has cleared the way for Eyenuk Inc. to market its Eyeart autonomous artificial intelligence (AI) system for DR screening in the U.S.

Novasight Ltd. has scooped up $8 million in a series A financing that’s intended to get the company through a pivotal study of its first U.S. indication, Curesight, as well as to advance other pipeline products. The Israeli startup is tackling a range of pediatric vision disorders using artificial intelligence and eye-tracking technology.

Dry eye disease is a common problem, and Sight Sciences Inc., of Menlo Park, Calif., is looking to help those who suffer from the condition. Now, the company has seen the presentation of positive clinical data from the multicenter OLYMPIA study of Tearcare, which the company has heralded as the first wearable and intelligent eyelid technology for dry eye treatment.

Irvine, Calif.-based startup Ocutrx Vision Technologies LLC unveiled new technology that it said helps surgeons better visualize the operative field during surgical procedures. The OR-Bot Surgery Visualization Theatre combines augmented reality (AR), virtual reality (VR) and both human- and robot-controlled arms to facilitate exacting medical procedures without the need for physicians to look away from the patient.