FDA clears device for MGD treatment

Novoxel announced that the FDA cleared its Tixel i device in the U.S. The Tixel i is, according to the company’s press release, a device that delivers localized heat and pressure to the upper and lower eyelids to help treat patients with evaporative dry eye due to meibomian gland dysfunction. The company reported that in a multicenter clinical study the device showed significant improvements in tear breakup time and meibomian gland secretion scores, as well as patient-reported symptoms. The Tixel system uses what the company calls Thermo-Mechanical Action instead of light or laser energy to accomplish the treatment.

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Significant investments made in whole-eye transplant research

The Advanced Research Projects Agency for Health (ARPA-H), an agency that is part of the U.S. Department of Health and Human Services, has identified teams that will receive up to $125 million to pioneer whole eye transplantation to restore vision to those blind and visually impaired. The investment is part of ARPA-H’s Transplantation of Human Eye Allografts (THEA) program. The teams selected by ARPA-H are InGel Therapeutics, Stanford University, the University of Colorado Anschutz Medical Campus, and the University of Miami Bascom Palmer Eye Institute. These teams, as part of the THEA program, will contribute to research and development in the following areas, according to the ARPA-H news release: “(1) retrieval of donor eyes and maintenance of the health of donor eyes until transplantation; (2) optic nerve repair and regeneration; and (3) surgical procedures, post-operative care, and functional assessment.”

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Enrollment completed early in Phase 3 trial for novel glaucoma drop

Nicox announced that enrollment in its second Phase 3 trial for NCX 470 has been completed early in China; enrollment for the U.S. portion was completed in July. This trial is evaluating the novel nitric oxide-donating bimatoprost drop for IOP lowering in patients with open-angle glaucoma. Topline results from this trial are expected in the third quarter of 2025. Combined with the already released topline results of the first Phase 3 trial, these are expected, according to the company’s press release, to support the clinical regulatory requirements for a New Drug Application. The company estimates that this NDA submission could come in 2026.

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Studies make progress with gene and mRNA-based therapies for retinal conditions

Two recent studies have been published, providing updates on the use of gene and mRNA-based therapies for different retinal conditions.

• Published in the Proceedings of the National Academy of Sciences, researchers have shown that a CRISPR/CAS9 adenine base editing strategy could correct an E150K mutation, as shown through in vivo editing in a Rho-E150K mouse model, which is a model of autosomal recessive retinitis pigmentosa caused by mutations in the protein rhodopsin. The gene therapy was administered via subretinal injection and resulted in an “up to 44% Rho correction in homozygous Rho-E150K mice.” The authors specified that injection at post-natal day 15 “but not later time points,” was able to restore rhodopsin expression, partially rescue retinal function, and partially preserve retinal structure. The findings, they continued, show that “in vivo base editing can restore the function of mutated structural and functional proteins in animal models of disease, including rhodopsin-associated RP and suggest that the timing of gene-editing is a crucial determinant of successful treatment outcomes for degenerative genetic diseases.”
• An mRNA-based treatment demonstrated promise as a possible non-surgical treatment for proliferative vitreoretinopathy (PVR) in a study published in Science Translational Medicine. The research, according to the authors, designed the mRNA to “express a dominant-negative inhibitor of RUNX1 (RUNX1-Trap),” with runt-related transcription factor-1 (RUNX1) being implicated as a driver of the cellular changes that occur in the disease. Administration of the RUNX1-Trap “delivered in polymer-lipidoid complexes or lipid nanoparticles sequestered RUNX1 in the cytosol and strongly reduced proliferation in primary cell cultures established from fibrotic membranes derived from patients with PVR.” In both rabbit and mouse models in vivo and an ex vivo explant human model, the data support the “therapeutic potential of mRNA-encoded therapeutic molecules with dominant-negative properties, highlighting the potential of mRNA-based therapies beyond standard gene supplementation approaches.”

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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.
• ASCRS Live!: This educational dinner series, which made its way to several cities across the U.S. in 2024, has wrapped up for the year. Stay tuned for information about 2025 in-person events.
• 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 randomized, prospective, patient- and examiner-masked clinical trial compared the incidence and intensity of posterior capsule opacification (PCO) and YAG capsulotomy rates over 3 years between two open-loop, single-piece, hydrophobic acrylic IOL designs that only differed slightly in material, optic surface, and posterior edge. One hundred patients were randomized to receive the Vivinex XY1 IOL in 1 eye and the Clareon CNA0T0 IOL in their other eye; after 3 years, 67 patients remained for follow-up examination. The PCO score (from 0–10, assessed subjectively as well as objectively with digital retroillumination pictures and automated image analysis software) had a score of 1.0±1.0 compared the Clareon IOL, which had a score of 1.5±1.2. Eyes with the Clareon IOL were more likely to have a YAG capsulotomy (9.0%) compared to the Vivinex eye (7.5%). The authors concluded that both IOLs had low PCO and YAG rates, but there was a small, significant difference in favor of Vivinex. The research is published in the Journal of Cataract & Refractive Surgery.
• Retrospective analysis of prospectively collected 24-month efficacy and safety data of the Xen 45 gel stent (AbbVie) was published in the British Journal of Ophthalmology. The analysis is based on data from the Fight Glaucoma Blindness observational registry. In the study, complete success was defined as achieving an IOP reduction of 20% or more postop compared to preoperative baseline and an IOP between 18 mm Hg and 6 mm Hg without a secondary procedure at 2 years postop and without use of IOP-lowering medications. Qualified success was defined as the prior parameters but with the use of IOP-lowering medications. The study included 646 eyes of 515 patients with a mean baseline IOP of 21.4±7.6 mm Hg and 2.7±1.3 IOP-lowering medications. At 24-months follow-up after Xen implantation, mean IOP was 16.8±7.3 mm Hg, for a 21.7% reduction and patients were on a mean of 1.2±1.4 IOP-lowering medications. The authors noted that complete and qualified success were higher in the group that had Xen as a standalone procedure, compared to those who had Xen and cataract surgery. Bleb needling was needed in 28.4% of cases, and 18% of patients had a secondary procedure within the follow-up time.

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Product news

• Nidek announced the global launch of its NP-T Preloaded Toric IOL Injection System, which allows for delivery of a preloaded aspheric hydrophobic acrylic toric lens in two steps (fill with viscoelastic and press the plunger).
• Formosa Pharmaceuticals entered into an exclusive licensing agreement with Medvisis Switzerland for commercialization of clobetasol propionate ophthalmic suspension, 0.05%, for treatment of postop inflammation and pain following ocular surgery. This treatment received FDA approval in March 2024 and launched in the U.S. in September 2024.

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