NDA submitted for epithelium-on crosslinking therapy

Glaukos submitted a New Drug Application to the FDA for Epioxa, an epithelium-on crosslinking therapy with its iLink system for treatment of keratoconus. If approved, Epioxa would be the first FDA-approved, non-invasive corneal crosslinking therapy that doesn’t require removal of the corneal epithelium as part of the treatment.

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Positive results in Phase 2 trial for first-in-class therapy for acute optic neuritis

Oculis announced that it achieved positive safety and efficacy endpoints in its Phase 2 trial evaluating OCS-05 for treatment of acute optic neuritis. According to the company’s press release, OCS-05, a novel peptidomimetic small molecule candidate, is a potential first-in-class neuroprotective therapy. The Phase 2 trial randomized 36 patients to receive OCS-05 2 mg/kg/day, 3 mg/kg/day, or placebo administered intravenously for 5 days (33 patients ended up receiving treatment). Patients included in the trial had recent vision loss symptoms due to unilateral acute optic neuritis of demyelinating origin and were also receiving steroid therapy. OCS-05 achieved its primary safety endpoint with “no difference in percentage of patients with abnormal [electrocardiogram] parameters between the two treatment arms” as well as key secondary endpoints, which included changes in retinal structure (improvement in ganglion cell-inner plexiform layer thickness and improvement in retinal nerve fiber layer thickness) and changes in visual function (difference in low contrast letter acuity). OCS-05 has received an Orphan Drug Designation from the FDA and EMA, and its Investigational New Drug Application with the FDA was cleared, allowing for its clinical development in the U.S.

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Study: long-term, real-world findings evaluating standalone canaloplasty and trabeculotomy

Sight Sciences announced that the “largest [study] to date” evaluating standalone canaloplasty and trabeculotomy with the OMNI Surgical System was published in the American Journal of Ophthalmology. The study, which includes 36-month clinical outcome data from 230 eyes of 196 patients from the AAO IRIS Registry, found the following: mean IOP at every timepoint compared to baseline over 36 months was 15.1–16.7 mm Hg (mean baseline was 22.1 mm Hg). Subgroup analysis, according to the company’s press release, showed that patients with IOP more than 18 mm Hg had greater IOP reductions with the procedure. Eyes with IOP less than 18 mm Hg at baseline showed reductions in medication use, while those with IOP higher than 18 mm Hg showed a statistically significant reduction in both IOP and medication use through 36 months, according to the company.

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Phase 1b study evaluating sozinibercept for DME published

Opthea announced publication of its Phase 1b trial of sozinibercept combination therapy for treatment of diabetic macular edema (DME) in the journal Translational Vision Science & Technology. Patients included in the trial had previously been treated with anti-VEGF-A monotherapy and maintained persistent DME. This first-in-human, open-label, multicenter, dose-escalating trial included 9 patients who received 0.3, 1, or 2 mg of sozinibercept in combination with 2 mg of aflibercept every 4 weeks for 12 weeks. The combination therapy, according to the company’s press release, was found to be well tolerated with no dose-limiting toxicities and demonstrated a dose-response relationship of increased BCVA, with the 2 mg sozinibercept combination showing the highest BCVA gain. The company stated that sozinibercept is a “novel, first-in-class VEGF-C/D ‘trap.’”

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Phase 2 study for topical dry AMD therapy begins

Galimedix Therapeutics announced that it has begun a Phase 2 study to evaluate GAL-101 drops to slow or stop progression of dry AMD (geographic atrophy). The trial will enroll 110 patients in the U.S., Europe, and Israel who will be randomized 1:1 to receive either the study drop or placebo. The primary endpoint is reduction in rate of change of geographic atrophy lesion size. The rate of change in area of photoreceptor degeneration and functional outcome measures will be evaluated as well. The company is also studying an oral formulation of GAL-101 (Phase 1). According to the company, both studies are being funded with collaboration partner Théa Open Innovation.

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FDA clears IND for gene therapy targeting Stargardt disease

ViGeneron announced that the FDA cleared its Investigational New Drug application for a Phase 1/2 study of VG801 as a possible gene therapy to treat Stargardt disease and other retinal dystrophies associated with ABCA4 gene mutations. According to the company’s press release, VG801 uses a proprietary dual AAV vector technology because the ABCA4coding sequence is too big for a single AAV vector. The Phase 1/2 study will be multicenter, open label, and dose escalation to evaluate safety, tolerability, and preliminary efficacy.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
• Video submission opportunities: Several symposia at the upcoming ASCRS Annual Meeting are seeking case videos. Learn more about these submission opportunities, due January 17, here.
• Online education: There are a few recently posted online education opportunities from ASCRS: 1) ASCRS Ground Rounds, 2) a webinar focusing on OCT from the Retina Clinical Committee, 3) ASCRS Live! Roundtable, and 4) a YES Connect webinar.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

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Research highlights

• A new method to objectively quantify posterior capsule opacification (PCO) with swept-source anterior segment OCT (SS-AS–OCT) in pseudophakic eyes was evaluated in a cross-sectional study published in the Journal of Cataract & Refractive Surgery. The study included 180 eyes with PCO. According to the paper, “PCO irregular degree (PID), defined to evaluate the surface irregularity of PCO, the average and maximum thickness of PCO (AT-PCO, MT-PCO) were applied to quantify PCO based on SS-AS–OCT (CASIA2, Tomey) images.” The authors also recorded CVA, HOAs, modulation transfer function, and Strehl ratio. Association between the OCT parameters and visual function parameters were assessed. The authors found that PID, AT-PCO, and MT-PCO had significant correlations with CVA, Strehl ratio, and HOAs. They added that the correlation of the 3 parameters with Strehl ratio and HOAs were significantly higher than those of clinical PCO grading with Strehl ratio and HOAs. The authors concluded that the research “provides a new method for objectively quantifying PCO using successive cross-sectional SS-AS–OCT images. AT-PCO, MT-PCO, and PID are presented as new indicators to document PCO severity, with PID offering a unique perspective by considering the irregularity aspect of PCO.”
• A new artificial tear formulated with arabinogalactan, hyaluronic acid, and trehalose to treat dry eye disease was evaluated in a retrospective, real-world, post-marketing study. That included 96 patients with signs and symptoms of dry eye. The authors reported a 98% positive response (via patient questionnaire) to the drop with reported improvements in vision (13%), comfort (39%), redness (13%), itching (16%), photophobia (4%), and tearing (14%). The authors reported that 61% of patients experienced 1–2 hours of comfort from the drop. The research is published in the journal Clinical Ophthalmology.

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