Eyes on June 2026: Approvals, pipeline momentum, and AI under the microscope

June delivered a busy slate across Ophthalmology Times, from a fresh FDA approval and a wave of pipeline milestones to a sharper look at where artificial intelligence helps clinicians and where it still falls short. Here are the stories worth your time this month.

Regulations and Approvals

The headline approval came late in the month, when the FDA cleared veligrotug-vvze (Lumvoa) for thyroid eye disease across both active and chronic stages, delivering rapid proptosis and diplopia improvements with a 12-week IV regimen. On the pipeline front, the FDA accepted Outlook Therapeutics' resubmitted BLA for ONS-5010 (LYTENAVA), now carrying a PDUFA target action date of July 29, 2026. In rare disease, Belite Bio completed its rolling NDA submission for tinlarebant, a potential first approved therapy for Stargardt disease type 1. Glaucoma watchers also took note as NCX 470 received encouraging regulatory feedback in China ahead of a planned US NDA submission.

Retina and Inherited Disease

The retina desk stayed active. A preference study from Csaky and colleagues found that lesion growth rate reduction was the primary driver of geographic atrophy treatment decisions among US retina specialists, who showed greater risk tolerance for foveal-threatening lesions. New money entered the space as well: Memento Medicines launched with a $93 million Series A to advance MMT-205, a bispecific antibody that activates Tie2 while inhibiting VEGF, toward IND-enabling studies and first-in-human trials slated for 2027. In gene and inherited-disease research, Atsena dosed the first patient in the phase 3 pivotal cohort of the LIGHTHOUSE trial evaluating ATSN-201 for X-linked retinoschisis, while Alkeus Pharmaceuticals dosed the first participant in the phase 3 NORTHSTAR trial of oral gildeuretinol for Stargardt disease.

Artificial Intelligence

AI coverage leaned toward a clear-eyed assessment of limits. A study found that ChatGPT-5 overpredicts success after macular hole surgery, outperforming specialists on paper but missing failures. On the training side, researchers reported that a balanced mix of AI-generated and smartphone-captured images eliminated the domain-specific failures seen with single-source training. Prompt design mattered too: step-by-step reasoning prompts boosted multimodal AI accuracy on bilingual ophthalmology vignettes with images, though weak subspecialty and image-reading skills persisted. And in imaging-driven diagnostics, optical coherence tomography angiography revealed distinctive microvascular signatures in retinal layers associated with stages of cognitive decline in Alzheimer disease.

Glaucoma

Two real-world studies stood out. A large cohort study found obstructive sleep apnea associated with elevated glaucoma risk, though whether positive airway pressure therapy plays a role remains unclear. On the procedural side, a retrospective study of direct selective laser trabeculoplasty in 218 eyes showed significant IOP lowering, with the greatest benefit in treatment-naive eyes.

Cornea and Anterior Segment

A prospective pilot series found Keraring implantation cut refractive cylinder by 61% in non-ectatic corneas, opening a conversation about expanding ICRS indications. A notable case report described image-guided surgical excision combined with cryotherapy and a single anterior chamber methotrexate injection for corneal epithelial downgrowth, with no recurrence at 10 months. In the pipeline, Dompé initiated the phase 3 Orunea trial of cenegermin-bkbj for persistent corneal epithelial defects.

Industry and Devices

Deal activity included Bayer's acquisition of Perfuse Therapeutics and its endothelin-blocking implant PER-001, alongside a partnership with AI firm Iambic to speed small-molecule discovery. On the imaging side, Heidelberg Engineering announced FDA clearance for a new SPECTRALIS software release featuring a 250 kHz OCT angiography scan speed and enhanced eye tracking. And in cataract surgery, the TECNIS PureSee IOL launched in the US following its FDA approval.