Topline Phase 2 results for drug treating neuropathic corneal pain

OKYO Pharma announced topline Phase 2 results from its 18-patient trial evaluating urcosimod (OK-101) as a treatment for neuropathic corneal pain. According to the company’s press release, this randomized, double-masked, placebo-controlled, proof-of-concept trial at a single site found after 12 weeks of treatment that 75% of patients who received urcosimod 0.05% showed a more than 80% reduction in neuropathic corneal pain measured on the visual analogue scale. Pain score reductions were demonstrated as early as week 4, and responders had moderate to severe neuropathic corneal pain scores, despite maximum prior medical therapy, when entering the study. There were no serious adverse events. The company stated that after full data analysis is complete, it is planning a meeting with the FDA to discuss next steps. Urcosimod has a Fast Track designation from the FDA. There is currently no FDA-approved treatment for neuropathic corneal pain.

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Phase 3 blepharitis treatment doesn’t meet primary endpoint

Viatris announced that its Phase 3 study to evaluate the safety and efficacy of pimecrolimus 0.3% (MR-139) ophthalmic ointment twice daily for treatment of blepharitis did not meet its primary endpoint of complete resolution of debris at 6 weeks. The study included 477 patients who were randomized to receive MR-139 or placebo, self-administered twice daily. They were observed for 12 weeks. According to the company’s press release, Viatris is evaluating the next steps for its Phase 3 program, which could include revisions to its additional Phase 3 trial.

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Study: therapeutic potential of collagen mimetic peptides for myopia

Stuart Therapeutics announced publication of a study in the journal Pharmaceuticals that demonstrates the therapeutic potential of collagen mimetic peptides (CMPs) in treating ophthalmic diseases like myopia. According to the company’s press release, CMPs are “designed to bind and repair disease- and trauma-damaged collagen.” The study used atomic force microscopy to measure how stress caused by elevated IOP affected the stiffness of the peripapillary sclera and glial lamina in an animal model (rats) and if these changes could be influenced with topical mimetic of type I collagen. According to the study, after 4 weeks of elevated IOP, there was a “reduction in tissue stiffness correlated with an increase in fragmented collagen.” The topical CMP was applied countering both stiffness and fragmented collagen. The authors concluded that the collagen remodeling that occurs in glaucoma and myopia could be repaired with application of CMPs. Stuart Therapeutics has demonstrated in a Phase 3 trial of ST-100 for dry eye disease that its CMP (PolyCol) is well tolerated. The company stated that “a well-tolerated and effective therapeutic for myopia would provide a welcome relief to a very large population” and “ability of CMPs to restore scleral stiffness are significant.”

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FDA accepts NDA resubmission for dry eye therapy

Aldeyra Therapeutics announced that the FDA accepted its New Drug Application (NDA) for reproxalap, which it resubmitted in June for its investigational drug for treatment of signs and symptoms of dry eye. The PDUFA target action date is December 16. Company leadership stated that the NDA resubmission included a single clinical trial that achieved a primary endpoint of reducing ocular discomfort compared to vehicle/control, which was based on the FDA’s request for an additional trial showing efficacy in treating symptoms of dry eye disease.

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Partnership news

• Topcon has partnered with OKKO Health, providing seed funding, to advance OKKO Heath’s home vision monitoring platform. According to the company’s press release, OKKO’s technology does not require external hardware and is powered by the patient’s smartphone. It will be intended for monitoring of macular diseases and other chronic eye conditions.
• Harrow entered into a definitive agreement with Samsung Bioepis for exclusive commercial rights in the U.S. to develop Samsung Bioepis’ biosimilars, including BYOOVIZ (ranibizumab-nuna) and OPUVIZ (aflibercept-yszy). According to the company, the transition of these commercial rights is expected to be complete by the end of 2025.
• Nicox granted exclusive rights to Kowa to develop and commercialize NCX 470 as an IOP-lowering agent for treatment of glaucoma or ocular hypertension in the U.S. and other territories worldwide (excluding Japan where it already has a license and China, Korea, and Southeast Asia, which are licensed to Ocumension Therapeutics).

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ASCRS news and events

• Business of Refractive Cataract Surgery Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home Resource Library, will help practices gain the navigational tools needed to increase premium IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Salt Lake City, Utah, on August 21.
• 2026 ASCRS Annual Meeting: Hotel room blocks are open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026. The call for submissions is also ongoing until September 1. Submit an abstract and get involved in the 2026 ASCRS Annual Meeting.

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Research highlights

• Ocular dominance with a new sensory test—a simultaneous, binocular, head-mounted visual simulator—was assessed at 5 U.S. practices in a prospective, multicenter, double-masked, non-interventional, comparative study. Results from the visual simulator were compared to patients using a “hole-in-the-card” method for distance dominance testing. The study included 326 participants. It found strong ocular dominance at far in 50% of participants, at near in 56% of participants, and “roughly equal remaining distribution between weak and equidominance.” In 41% of participants the dominant eye selected using the “hole-in-the-card” method did not match the virtual sensory dominance test, and 26% of participants saw a change from right eye dominance with hole-in-the-card to left eye dominance with the virtual similar (15% changed from left to right). The authors concluded that the hole-in-the-card test “often does not align with the patient’s preferred eye using sensory testing with a visual simulator simulating monovision.” They propose further study to “determine whether both strength and localization of ocular dominance in planning monovision are important factors in predicting patients’ satisfaction and adaptation to monovision.” The study is published in the Journal of Cataract & Refractive Surgery.
• The safety and efficacy of phacoemulsification alone vs. phaco plus iStent (Glaukos) for patients with primary angle closure glaucoma were assessed in a retrospective, cohort, multicenter study published in the journal Eye. Complete success (the primary outcome) was defined as an IOP of 6–18 mm Hg without reoperations and a 20% or more reduction in IOP from baseline without medications. Qualified success in the study was defined as an IOP of 6–18 mm Hg without reoperations but with a reduction in at least 1 medication or a 20% or more reduction in IOP on the same medications. The study enrolled 185 eyes (90 in the phaco-alone group and 95 in phaco plus iStent). The investigators found no difference in IOP reduction between the two groups, but the medication reduction was greater in the phaco plus iStent group at month 1, 12, and 24. Complete success was achieved in 13.8% of phaco-iStent recipients and 10.1% in the phaco-alone group; qualified success was achieved in 54.3% and 62.0% of phaco-iStent and phaco-alone patients, respectively. Cystoid macular edema and anterior uveitis occurred in 6 phaco-iStent participants. The authors reported no long-term sight threatening complications or difference in postop visual acuity in either group.

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Product news

• Lupin Limited launched loteprednol etabonate ophthalmic suspension 0.5% in the U.S. as a bioequivalent to Lotemax Ophthalmic Suspension 0.5% (Bausch + Lomb).

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