EyeWorld

Ciliatech announced approval by the U.S. FDA of the company’s Investigational Device Exemption (IDE) application to initiate a feasibility study in the U.S. of the INTERCIL Uveal Spacer for glaucoma. The study is expected to enroll approximately 30 patients at three U.S. clinical sites and will evaluate the safety and performance of INTERCIL in patients with primary open-angle glaucoma (POAG).

Kowa Pharmaceuticals announced that the U.S. FDA has accepted for review the New Drug Application (NDA) for K-911 (bimatoprost grenod, also known as NCX 470), an investigational topical ophthalmic monotherapy for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.

Sight Sciences announced that, effective August 18, 2026, the U.S. FDA updated the TearCare System Indications for Use to state: “The Sight Sciences TearCare System is a thermal-activated gland expression therapy that improves meibomian gland function in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.” As a result of this expanded indication, the company’s press release noted...

ZEISS Medical Technology announced the 510k clearance from the U.S. FDA for ZEISS CLINIC 360. The company described this as an all-in-one cloud and browser-based software solution, which combines diagnostic and medical data into a comprehensive patient view. “By making relevant information easy to access and review, the solution helps clinicians evaluate disease progression, support treatment decisions, and improve workflow efficiency,” the company’s press release stated.

Belite Bio announced that the FDA accepted and granted Priority Review designation of the New Drug Application (NDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1). Additionally, the FDA set a Prescription Drug User Fee Act (PDUFA) date of February 12, 2027. The company’s press release noted that “the filing was based on the results from the Phase 3 DRAGON trial, which evaluated tinlarebant for the treatment of STGD1.

Sight Sciences announced U.S. FDA 510(k) clearance of the OMNI Ultra Surgical System (OMNI Ultra) for canaloplasty followed by trabeculotomy for the reduction of IOP in adult patients with primary open-angle glaucoma (POAG).

Outlook Therapeutics announced that the U.S. FDA approved LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD).

Bausch + Lomb announced the U.S. launch of the EyeGility Inserter preloaded IOL delivery system.

Dompé announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). This Phase 3 trial will involve more than 130 centers globally, and it is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION.

Harrow announced the commercial launch of BYOOVIZ, an FDA-approved biosimilar referencing Lucentis (ranibizumab, Genentech) and developed by Samsung Bioepis Co. Ltd. The launch follows Harrow’s announcement last year of its exclusive U.S. commercialization agreement with Samsung Bioepis. Through this partnership, Harrow obtained exclusive U.S. rights to commercialize BYOOVIZ and OPUVIZ (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEA (aflibercept, Regeneron).