Whole-eye transplant 1 year later

A press release from NYU Langone Health and a paper published in the Journal of the American Medical Association are reporting on the 1-year outcomes of the world’s first whole-eye transplant combined with a partial face transplant. Among the 1-year findings are that the donor eye has maintained normal pressure and achieved sustained blood flow. The patient has not gained vision in the transplanted eye, but the press release stated that a photoreceptor response was detected, indicating that the rods and cones in the retina survived the transplant procedure; the patient does not perceive light, however, through the transplant. The patient, in the press release, stated that while he cannot see through the transplant, he feels he has regained his quality of life. The authors of the paper concluded that the transplant demonstrates “allograft survival including rejection-free graft survival and electroretinographic measurements indicating retinal response to light stimuli. These data highlight the potential for clinical allotransplantation for globe loss.”

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Phase 3 trial investigating new presbyopia drop therapy begins

Ocuphire Pharma has begun a Phase 3 trial evaluating phentolamine ophthalmic solution, 0.75%, for treatment of presbyopia, dosing its first participants. According to the company’s press release, this study is randomized, double masked, placebo controlled, and multicenter, enrolling 545 participants to receive the investigative drop or placebo 3:2. The primary endpoint is percentage of participants with 15-letter improvement in photopic binocular DCNVA 8 days after their first visit; this improvement is relative to each participant’s baseline. Patients will be followed for 48 weeks for safety data collection. Topline data from this trial is expected in the first half of 2025.

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Study reports on multi-interventional glaucoma technique

The safety of Iantrek’s bio-interventional, microinvasive uveoscleral outflow technology was reported on in the Journal of Clinical Medicine. According to the paper, the procedure includes cyclodialysis with allogenic “bio-spacers” placed to “maintain patency of the internal filtration conduit” (bio-scaffolded cyclodialysis, BSC). The study included 243 consecutive eyes with open angle glaucoma that had the procedure; 79% of these eyes had phacoemulsification cataract surgery prior to the BSC procedure and the rest were standalone. There were no sight-threatening or serious adverse events within the at-least 30-day follow-up period. There was one case of prolonged iritis, which eventually resolved, two cases of intraoperative hyphema, five cases of postop hyphema, 11 cases of IOP elevation, and one case of numeric hypotony without maculopathy. All of these resolved with management. According to the paper, the rate of secondary surgical intervention needed for IOP control was low, and IOP improved in the postop period with 78.6% of eyes achieving an IOP of 18 mm Hg or less without a need for more medications.

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Topline results from Phase 3 trial for drug for active thyroid eye disease

Viridian Therapeutics announced that it achieved all primary and secondary endpoints in its Phase 3 trial for veligrotug, an anti-IGF-1R antibody, as a possible therapy for thyroid eye disease. According to the company’s press release, there was a 70% proptosis responder rate at week 15 (placebo-adjusted to 64%). In addition, 54% of patients experienced complete resolution of diplopia, and 64% achieved a clinical activity score reduction to 0 or 1. A BLA submission is anticipated in the second half of 2025.

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Pilot study complete for AMD treatment

OcuDyne announced that it completed a 6-month pilot study that evaluated the company’s OPTiC System for treatment of AMD. The company’s press release stated that procedural feasibility was established (ocular artery angioplasty for the treatment of vascular lesions associated with geographic atrophy), and secondary and exploratory endpoints were demonstrated as well. The company reported subjective and objective evidence of visual function preservation at 6 months. OcuDyne described itself as a “clinical stage company dedicated to exploring the potential causative implications of cardiovascular disease on AMD and treating this disease with cardiovascular therapies.”

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ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery Summit: This new course taking place September 27–28 in Irving, Texas—along with its extensive, take-home resource library—will help practices gain the navigational tools needed to increase advanced-technology 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 2024. Registration is open for the event in Atlanta, Georgia, on October 3.
• ASCRS Foundation: There are two opportunities for young eye surgeons currently accepting applications: the Young Eye Surgeons International Service Grant and the Resident Excellence Award.
• 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

• The visual and refractive outcomes of the second-generation light adjustable lens in eyes with prior laser corneal refractive surgery was investigated in a retrospective, consecutive case series. According to the paper published in the Journal of Cataract & Refractive Surgery, eyes in the study were targeted for plano in their cataract surgery. The primary outcomes were UDVA, CDVA, and percentage of eyes within ±0.25 D, ±0.50 D, and ±1.00 D of refractive target. The study included 76 eyes of 70 patients; 45 eyes had history of 1 prior refractive surgery and 31 eyes 2 or more refractive surgeries. Seventy-four percent of eyes achieved a UDVA of 20/20 or better, 88% achieved a UDVA of 20/25 or better, and 93% were correctable to at least 20/20. Sixty-six percent of eyes (n=50) were within ±0.25 D of target, and 86% (n=65) were within ±0.50 D of refractive target.
• A retrospective chart review of 445 eyes of 247 patients evaluated the refractive predictability of Argos (Alcon) measurements with the Barrett Universal II formula and the Barrett True Axial Length formula in long, medium, and short axial length eyes. The authors found that the postop mean absolute prediction error was 0.36±0.33 D for the Barrett Universal II and 0.34±0.32 D for the Barrett True Axial Length (p=0.04). In eyes with a short axial length, the mean absolute prediction error was 0.45±0.37 D and 0.37±0.31 D (p<0.001) for the Barrett Universal II and the Barrett True Axial Length formulas, respectively. There was not a significant difference between the two formulas in eyes with long or medium axial lengths. The research is published in the journal Clinical Ophthalmology.

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Product news

• Oculus premiered its Pentacam Cornea OCT, which combines Scheimpflug technology and ultra high-resolution OCT of the cornea in a single measurement.
• Eyenovia announced that it obtained approval for an export license from Taiwan, in collaboration with Formosa Pharmaceuticals, to ship clobetasol propionate ophthalmic suspension, 0.05%, to the U.S. This is the company’s late-stage asset in development for progressive pediatric myopia.
• Alcon unveiled its SMARTCataract DX digital planning solution and NGENUITY 1.5, which adds connectivity capabilities.

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