Positive topline Phase 3 confirmatory trial results for transepithelial crosslinking

Glaukos announced positive topline results from its Phase 3 confirmatory trial evaluating efficacy, tolerability, and safety of Epioxa, its transepithelial crosslinking therapy. According to the company’s press release, the primary efficacy endpoint was met, showing a clinically relevant and statistically significant improvement in Kmax at 12 months postop from baseline in the Epioxa treated group vs. sham/placebo. The company noted that the treatment was well-tolerated with no patients in the Epioxa group discontinuing the study early due to adverse events; there were no serious ocular adverse events reported. Adverse events that were reported were described as mild and transient. There were no reported systemic effects and no change in corneal endothelial cell counts over 12 months. The results from this second Phase 3 trial and the first, the company reported, are expected to support an NDA submission for Epioxa by the end of 2024. Previously, Glaukos had a pre-NDA meeting with the FDA, confirming that “the company’s clinical data package, including the two completed Phase 3 pivotal studies, would be sufficient to support an NDA submission and review,” the press release reported.

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18-month data from first-in-human drug-eluting IOL

SpyGlass Pharma released 18-month data from its first-in-human study of the SpyGlass Intraocular Lens-based Drug Delivery Platform. In this research, 23 patients with glaucoma or ocular hypertension received the IOL, achieving a sustained reduction in IOP in the three studied dose strengths (mean pressure reduction was 43.7% compared to baseline). All patients, according to the company’s press release, remained off IOP-lowering drops at 18 months of follow-up, and all achieved an IOP reduction of more than 20% from baseline. Ninety-six percent of patients had an IOP of 18 mm Hg or lower at month 18. The company is enrolling for its Phase 1/2 study in the U.S.

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New Phase 2 findings for investigational geographic atrophy treatment

Annexon announced new findings from its Phase 2 trial evaluating ANX007 as a treatment for patients with geographic atrophy due to dry AMD. According to the company, the treatment showed “enhanced protection of vision and greater preservation of central photoreceptor cells in a subpopulation of patients with less advanced disease as measured by the photoreceptor ellipsoid zone (EZ) in the central fovea.” The company described ANX007 as a first-in-kind, non-pegylated antigen-binding fragment intravitreal injection that blocks C1q. In a quote, company leadership noted that these findings show the treatment’s ability to “deliver a differentiated benefit, particularly with earlier intervention in a neurodegenerative disease.”

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Study: long-term, low-dose antiviral treatment reduces risk for HZO patients

Research presented by NYU Langone at the recent AAO Annual Meeting as part of the 8-year Zoster Eye Disease study found that patients treated for a year with a low-dose of valacyclovir had a 26% reduction in risk of new or worsening eye disease and reduced pain (and subsequent need for neuropathic pain medication) at 18 months. The study was conducted at 95 medical centers in the U.S., Canada, and New Zealand, enrolling 527 participants between November 2017 and January 2023. Patients, who were 18 years or older with a history of HZO rash and active keratitis or iritis within the year before enrollment, were randomized to receive 1,000 mg valacyclovir daily or placebo. The efficacy of the low-dose antiviral, investigators in the press release said, support changes/additions to clinical practice from a 7- to 10-day course of antiviral treatment to a year of low-dose valacyclovir treatment.

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Acquisition news

Ocuphire announced that it acquired Opus Genetics, as part of its commitment to being a leader in “the development of gene therapies for treatment of [inherited retinal diseases].” Effective this week, according to the company’s press release, the combined company will be called Opus Genetics Inc.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is now open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2024. Registration is open for the events in San Diego, California, on November 7 and Charlotte, North Carolina, on November 14.
• ASCRS Foundation: Nominations are due November 8 for the Resident Excellence Award, which awards 10 exemplary residents a travel grant, 4 nights’ accommodation, complimentary registration, and invitations to leadership and social events at the 2025 ASCRS Annual Meeting.
• 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

• In a retrospective observational study, two large series of cataract eyes, with no history available on prior myopic laser vision correction, were used to update the corneal power conversion equation for the new Shammas-Cooke IOL calculation formula. The formula was tested in a set of 165 eyes and compared with three other no-history myopic laser vision correction IOL calculation formulas available on the ASCRS calculator (the Shammas PL, the Haigis-L, and the Barrett True-K NH). According to the paper published in the Journal of Cataract & Refractive Surgery, the new Shammas-Cooke formula performed better than the other no-history formulas with the percentage of eyes within ±0.50 D being 66.7%, 47.9%, 48.5%, and 65.5%, respectively, for the Shammas-Cooke, Shammas PL, Haigis-L, and Barrett True-K NH formulas.
• The utility of AI/deep learning for assisting in diagnosis of infectious keratitis was evaluated in terms of diagnostic accuracy in a systematic review and meta-analysis published in eClinicalMedicine, an online, open-access journal published by The Lancet. The investigators identified clinical registry studies related to deep learning and infectious keratitis between 1974 and July 2024, performing a meta-analysis to estimate sensitivities and specificities. The authors identified 963 studies, 35 of which were included. In the analysis, the authors concluded that deep learning models “may have good diagnostic accuracy for infectious keratitis and comparable performance to ophthalmologists.” They noted, however, that the “findings should be interpreted with caution due to the image-based analysis that did not account for potential correlation within individuals, relatively homogeneous population studies, lack of pre-specification of [deep learning] thresholds, and limited external validation.” The authors provided several recommendations for future studies.

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