Long-term data on treatment for neuropathic corneal pain

OKYO Pharma announced that urcosimod (OK-101) for treatment of corneal pain has shown long-term stability, which is required by the FDA for approval. The shelf stability of urcosimod, which is stored in single-use, daily ampoules, was confirmed when stored in refrigerated conditions over 2.5 years. Ongoing long-term stability at room temperature is still being assessed. The press release from the company noted that urcosimod is currently in a Phase 2b clinical trial involving 48 patients with neuropathic corneal pain.

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European agency issues positive opinion for low-dose atropine formulation

Sydnexis announced that the European Medicines Agency Committee for Medicinal Products for Human Use granted a positive opinion for its low-dose atropine formulation known as SYD-101, intended for slowing progressive pediatric myopia. According to the company’s press release, Santen has licensed the rights from Sydnexis to commercialize SYD-101, once issued a Marketing Authorization from the European Commission, as Ryjunea in Europe, the Middle East, and Africa. The FDA has already accepted an NDA for SYD-101 and assigned October 23 as the PDUFA date.

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Study: semaglutide use associated with increased risk of NAION

A retrospective study published in JAMA Ophthalmology has noted an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION) among patients with diabetes who use semaglutide. According to the paper, the cohort study, which used the TriNetX database between October 1, 2019 and December 31, 2023, identified patients with diabetes who had no prior history of NAION and were prescribed semaglutide. This group was compared to a control group of patients with diabetes who were prescribed a non-GLP-1 receptor agonist anti-diabetic medication. The study included more than 3 million patients with diabetes, 174,584 of whom received semaglutide and 174,584 who received a non-GLP-1 receptor agonist medication. While the study authors noted that patients taking semaglutide did not have an increased risk of NAION at month 1, month 3, month 6, or 1 year, there was an increased risk observed at year 2, 3, and 4. The authors concluded that the results suggest “semaglutide use was associated with increased risk of NAION in patients with diabetes.” They noted the study’s retrospective design caused some limitations and, thus, advocated for further studies.

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Company news

• Pantheon Vision and Eyedeal Medical announced an agreement to collaborate on the production and commercialization of the bioengineered corneal implant being developed by Pantheon Vision.
• Opthea announced the decision to discontinue its two Phase 3 trials investigating a treatment for wet AMD. According to the company’s press release, this decision was made due to one of the Phase 3 trials not meeting its primary endpoint in topline results analysis.

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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. Find the most up-to-date information on the Real-Time Program here.
• SightLine at ASCRS: This is a new day-long meeting April 24, ahead of the ASCRS Annual Meeting, for all commercial stakeholders in ophthalmology to learn about and collaborate on technologies and care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 24 from 1:00–5:30 p.m. in Los Angeles ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• 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. Tune in each week for a new video.

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Research highlights

• The safety and efficacy of thermomechanical action with Tixel C (Novoxel) compared to thermal pulsation with LipiFlow (Johnson & Johnson Vision) for patients with meibomian gland dysfunction (MGD) was the subject of a prospective, randomized, evaluator-masked, multicenter study. The results were published in the Journal of Cataract & Refractive Surgery. One hundred and six patients were randomized to each treatment group and assessed at baseline and 4 and 12 weeks post-treatment. The primary efficacy endpoint was change in tear breakup time (TBUT) at week 4. The thermomechanical action (TMA) treatment and thermal pulsation (TP) resulted in significantly improved TBUT at both timepoints, and the change in TBUT for TMA was found “noninferior” to TP. There were no significant differences between the treatment groups in OSDI scores, meibomian gland score, and corneal and conjunctival staining; these measures significantly improved from baseline. There were no device-related adverse events in either group.
• A pilot study involving a single center as a single-arm, investigator-initiated trial evaluated the efficacy of varenicline solution nasal spray (VNS) as a treatment for dry eye disease in patients with moderate to severe Sjogren’s disease. The study analyzed the tear film cytokine levels before and after the nasal spray use at days 14 and day 28. The nasal spray was administered twice daily for 28 days by 39 patients. The authors reported a statistically significant improvement in eye dryness scores, corneal staining, and conjunctival staining. There was also a statistically significant increase in tear secretion in unanesthetized Schirmer’s testing among patients whose baseline Schirmer’s was less than or equal to 5 mm. Several types of tear film cytokine concentrations decreased significantly. The authors concluded that this study contributes to “existing evidence that VNS improves subjective dry eye symptoms, corneal and conjunctival staining, and tear secretion in a subset of tear-deficient patients, while providing new evidence that VNS reduces concentration of pro-inflammatory cytokines in the tear film.” This study is published in the journal Clinical Ophthalmology.

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Product news

• Alcon launched the Clareon PanOptix Pro IOL, which the company stated “leverages proprietary ENLIGHTEN NXT Optical technology which delivers the highest reported light utilization of any trifocal IOL—and the lowest light scatter.”

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