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Nanoscope’s gene therapy, MCO-010 receives Sakigake and Orphan Drug Designations in Japan | Ophthalmology Times
(Image Credit: AdobeStock/sezerozger) Nanoscope Therapeutics has received Pioneering Regenerative Medical Product (Sakigake) and Orphan Drug designations for MCO-010 from Japan’s Ministry of Health, Labour and Welfare (MHLW), making it the first retinal gene therapy to do so in Japan. Sakigake designation is Japan’s…
Q&A: Evolving approaches to geographic atrophy management | Ophthalmology Times
(Image Credit: AdobeStock/Prostock-studio) Management of geographic atrophy (GA) has changed with the introduction of retinal therapies aimed at slowing disease progression and with greater use of imaging for diagnosis and monitoring. These developments have raised practical questions about patient selection,…
Q&A: Understanding Medicare payment shifts in eye care | Ophthalmology Times
Dustin D. French, PhD, examines 2 decades of Medicare reimbursement trends in ophthalmology, highlighting how changes in conversion factors, relative value units, and practice settings are affecting subspecialties and practice sustainability. (Image credit: AdobeStock/thatinchan) Medicare reimbursement for ophthalmology procedures has…
Ophthalmology pipeline watch: Key trial results and PDUFA dates for Q1 2026 | Ophthalmology Times
(Image Credit: AdobeStock/Iuliia Pilipeichenko) Editor’s Note: This content was generated with the assistance of AI. Clinical trial watchers can anticipate the release of data from a number of trials in the first quarter of 2026. The trials focus on Leber hereditary…
Rayner announces Sophi Phaco System in the US | Ophthalmology Times
The FDA has given 501(k) clearance to Rayner’s Sophi (Swiss Ophthalmology Innovation) Phacoemulsification System, making it available to cataract surgeons in the US, according to the company.1 The platform was designed with a focus on mobility, simplicity, and safety, which…
FDA clears first daily disposable EDOF contact lens for presbyopia | Ophthalmology Times
The US FDA has officially cleared the first and only daily disposable soft (hydrophilic) contact lens for presbyopia that utilizes patented Extended Depth of Focus (EDOF) optical design technology.1 The Cataltheia Group and its US subsidiary Bruno Vision Care stated…
Exploring Emerging Therapies in the Retinal Vascular Disease Pipeline | Ophthalmology Times
The final segment highlights the rapidly evolving pipeline of retinal vascular disease therapies and offers closing reflections from the panelists. The discussion emphasizes the promise of next-generation agents, including sustained-release implants, tyrosine kinase inhibitors (TKIs), and gene therapies. TKIs are…
First patient treated in dose-expansion portion of SpliceBio’s phase 1/2 ASTRA clinical trial | Ophthalmology Times
(Image Credit: AdobeStock/Ilya) SpliceBio has dosed the first patient in the Part B dose-expansion portion of its phase 1/2 ASTRA clinical trial (NCT06942572) evaluating SB-007 for the treatment of Stargardt disease. SB-007 is an investigational dual adeno-associated virus (AAV) gene…
Glaucoma innovation: Eight themes to watch in 2026 | Ophthalmology Times
Glaucoma care is evolving through the integration of artificial intelligence, advanced procedures, and personalized treatment strategies. (Image credit: AdobeStock/thodonal) As the ophthalmology community observes Glaucoma Awareness Month this January, glaucoma specialists point to incremental integration of technologies that support earlier…
FDA update: Outlook Therapeutics receives CRL for resubmitted ONS-5010 BLA | Ophthalmology Times
Outlook Therapeutics, Inc. reported that the FDA has issued a complete response letter (CRL) concerning the resubmitted biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg).1,2 The letter noted that the agency cannot approve the application in its current form for the…