First patient dosed in Phase 3 trial evaluating cenegermin for PCED

Dompé announced that it dosed the first patient in its Phase 3 clinical trial evaluating cenegermin-bkbj as a treatment for persistent corneal epithelial defect (PCED). According to the company’s press release, the study will enroll 150 adult patients and evaluate cenegermin against placebo with complete epithelial healing being the primary endpoint.

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First patient dosed in Phase 3 study for Stargardt treatment

Alkeus Pharmaceuticals dosed its first patient in its Phase 3 study evaluating oral gildeuretinol (ALK-001) for treatment of Stargardt disease. This randomized, placebo-controlled, double-masked 24-month trial will evaluate safety, efficacy, and pharmacokinetics of gildeuretinol for patients with advanced Stargardt disease and atrophic lesions. The primary endpoint is rate of atrophic lesion growth from 6–24 months. A key secondary endpoint is preservation of low luminance visual acuity.

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First patient randomized into registrational trial for first-in-class dry eye therapy

Oculis randomized the first patient in its first registrational trial evaluating the efficacy and safety of licaminlimab for treatment of dry eye disease, especially for patients with the TNFR1 genotype. The treatment’s effect in the “overall study population” will be evaluated as well. The company described TNFR1 as a “key receptor mediating TNFα-driven inflammation and apoptosis,” and noted that licaminlimab “has shown greater clinical response in patients with a specific TNFR1 genotype in Phase 2 trials.” The trial is designed to evaluate the effect of the investigational drug in this specific population with the “aim of delivering the first precision medicine treatment in ophthalmology,” according to the company. The trial will enroll about 160 patients, two-thirds of whom will have the TNFR1 genotype. The primary endpoint is change from baseline to Day 29 in the global ocular discomfort severity score in patients with the specified TNFR1 genotype.” The same outcome in the overall study population is a key secondary endpoint.

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FDA clears new software for retinal imaging machine

Heidelberg Engineering announced FDA clearance of its SPECTRALIS Software Version, which includes a 250 kHz scan speed for OCT angiography with SHIFT Technology, enhanced TruTrack Active Eye Tracking, and a Green Autofluorescence Module. According to the company’s press release, this update is “designed to deliver speed, workflow flexibility, and diagnostic depth to multimodal retinal imaging.”

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Company news

• Selagine Plasma has received intellectual property rights from Selagine Inc. and the University of Chicago, Illinois, to advance toward its goal of developing a pooled plasma platform that would “transition blood-derived ocular surface therapy from individualized, patient-specific preparation toward a standardized biologic manufacturing model.”

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ASCRS news and events

• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2026. Register for the next event, June 25 in Chicago, Illinois.
• ASCRS Online Education: The ASCRS CME Education Catalog offers a wealth of both CME and non-CME content for ASCRS members. Check out what your colleagues have been watching lately.
• ASCRS Annual Meeting: Hotel rooms are now available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location.

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EyeWorld article of the week

Robotic cataract surgery has hit some major milestones, and surgeons involved with these projects, as well as those involved with ancillary technologies, discussed them at the 2026 ASCRS Annual Meeting symposium “Robotic Surgery: How Soon and How Good Will It Be?” Read the recap of these discussions in “ASCRS symposium covers robotic surgery,” an EyeWorld Online Exclusive.

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Research highlights

• The visual and refractive outcomes using the VISUMAX 800 femtosecond laser (Zeiss) to perform KLEx and LASIK performed with the VISUMAX 800 femtosecond laser and the EX500 excimer laser (Alcon) for treatment of myopic astigmatism were compared in a single-center, retrospective, comparative study published in the Journal of Cataract & Refractive Surgery. The study included 237 eyes, 133 of which received KLEx and 104 femtosecond-LASIK. The authors found that at 6 months postop, UDVA and CDVA were comparable among the two groups. The KLEx group had a mean spherical equivalent closer to emmetropia compared to the LASIK group (−0.04±0.18 D vs. −0.10±0.15 D, P=.007), and residual cylinder was lower in the KLEx group. The authors concluded that both procedures performed with the VISUMAX 800 laser provided “excellent refractive outcomes,” with the KLEx procedures “incorporating an image-guided static cyclotorsion alignment strategy and demonstrating excellent refractive and vector analysis results.”
• A prospective observational study reviewed reading speed for patients who received binocular PanOptix trifocal IOLs (Alcon) at the time of cataract surgery and those who were age- and education-matched but who didn’t have cataract. The study enrolled 42 patients in the PanOptix group and 42 in the control/no cataract but presbyopic group. According to the authors, the PanOptix group had “significantly better binocular reading speed at 3 months postoperatively than the control group (219.81±35.94 vs 174.91±42.21 characters/min, P< 0.001).” Postop UCVA at all distances and corrected visual acuity at near and intermediate distances were also better in the PanOptix group vs. control. The authors concluded that bilateral PanOptix resulted in “significantly faster binocular reading speed compared with age-matched presbyopic individuals without near correction.” This study was published in the journal Clinical Ophthalmology.

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Product news

• Harrow is relaunching VERKAZIA (cyclosporine ophthalmic emulsion, 0.1%) for treatment of vernal keratoconjunctivitis.

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