South Korea’s Ministry of Food and Drug Safety (MFDS) has given innovative medical device designation for Te Bios Co. Ltd.’s artificial cornea, C-Clear, bringing it one step closer to becoming the first artificial cornea to be approved in the country.

Myopia, or near-sightedness, is a growing public health problem, often beginning in childhood. Severe cases can lead to serious complications including cataract, glaucoma and retinal detachment. Now, Dopavision GmbH has raised a €12 million (US$14.2 million) series A round to advance its digital childhood myopia therapeutic aimed at nipping this lifelong problem in the bud.

Eyeyon Medical Ltd. has won CE mark approval for its flagship product, Endoart, a synthetic implant that replaces the human endothelium, which the body can’t regenerate. Designed to treat chronic corneal edema, it could help to reduce the long wait times for human donor corneas. Approval was based on a first-in-human trials involving 22 patients who received Endoart implants and were followed for 24 months.

With the rollout of its Avagen test, Avellino Lab USA Inc. hopes to see a significant change in the diagnosis and management of keratoconus, a common cause of blindness. The test quantifies the risk of keratoconus and definitively diagnoses other corneal dystrophies, which are frequently misdiagnosed or undiagnosed until late in their development, when treatment is less effective and vision already impaired.

Heru Inc. has raised $30 million in a series A financing to support the further development of its artificial intelligence (AI)-enabled, wearable eye diagnostic and vision correction platform. D1 Capital Partners led the round, with participation from Softbank Ventures Opportunity Fund, Maurice Ferre, Frederic Moll, Krillion Ventures and a consortium of investors with expertise in developing, launching and scaling medical technologies.

Tesseract Health Inc. has closed an oversubscribed series B financing, reeling in $80 million with support from Foresite Capital, Glenview Capital and Opaleye. The proceeds will be used to advance the company’s Tesseract Ic eye-imaging diagnostic technology platform, including U.S. and overseas regulatory clearances. This is the first independent financing round for the Guilford, Conn.-based startup, which is developing a platform capable of diagnosing a range of diseases without a single blood draw. The company received prior seed funding as part of the 4Catalyzer med-tech incubator.

Pixium Vision SA reported that its merger with Second Sight Medical Products Inc. has foundered. The combination would have eased Paris-based Pixium’s entry into the U.S. market and Sylmar, Calif.-based Second Sight’s access to the European market, which Pixium has previously opposed, and enabled them to jointly develop and market neuromodulation devices that restore some degree of vision to the blind. The deal had been expected to close early in the second quarter of 2021.

The FDA has accepted Eyenovia Inc.’s new drug application (NDA) for Mydcombi, a fixed combination pupil dilation agent, with a PDUFA date of Oct. 28, 2021.

HONG KONG – Johnson & Johnson Vision (J&J Vision) has received its first global approval from Japan for its Acuvue Theravision with Ketotifen contact lenses. The Japanese Ministry of Health, Labour and Welfare’s green light will help with patients with vision correction, while simultaneously alleviating ocular allergic symptoms for allergic conjunctivitis, while they wear the lenses.