IDE approval for initiation of feasibility study for glaucoma uveal spacer

Ciliatech announced approval by the U.S. FDA of the company’s Investigational Device Exemption (IDE) application to initiate a feasibility study in the U.S. of the INTERCIL Uveal Spacer for glaucoma. The study is expected to enroll approximately 30 patients at three U.S. clinical sites and will evaluate the safety and performance of INTERCIL in patients with primary open-angle glaucoma (POAG). According to the company’s press release, “INTERCIL is a flat, trapezoidal glaucoma implant made of a hydrophilic acrylic material and placed through an ab externo surgical approach. It is designed to create controlled supraciliary spacing to support uveoscleral outflow without entering the anterior chamber or creating a subconjunctival bleb.”

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Launch of premium ophthalmic microscope

Alcon announced the initial commercial launch of UNITY M in select markets including the U.S. and Japan followed by Europe. The microscope is the latest addition to Alcon’s UNITY platform, “combining advanced optics, novel illumination, improved ergonomics, and intuitive usability in a modular design that enables practice-specific customization and future scalability,” according to the company’s press release. UNITY M offers surgical precision through advanced visualization technologies designed to provide stable, consistent views throughout surgery, the press release stated.

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Acceptance of BLA for treatment of retinitis pigmentosa with severe vision loss

Nanoscope Therapeutics announced that the U.S. FDA has accepted and filed the Biologics License Application (BLA) seeking approval of MOGENRY (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration for patients with retinitis pigmentosa (RP) having severe vision loss. According to the company’s press release, the BLA is supported by positive efficacy and safety data from the Phase 1/2a trial and the RESTORE Phase 2b/3 multicenter, randomized, double-masked, sham-controlled clinical trial. RESTORE met its primary and key secondary endpoints, demonstrating improvements in visual acuity at weeks 52 and 76. MOGENRY was well tolerated, with no treatment-related serious adverse events reported. If approved, MOGENRY would become the first gene-agnostic therapy to improve vision in patients with RP having severe vision loss.

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Launch of new feature for virtual reality patient education platform

VirtuaLens announced the launch of its new Mix and Match feature for the company’s virtual reality patient education platform and headset. According to the company’s press release, “Mix and Match allows surgeons to assign different types of IOLs to each eye, simulating treatment approaches commonly used to optimize vision across multiple distances. With the newest software update, you can now show patients a multifocal in one eye and EDOF in the other, or any number of mix-and-match combinations, using different technologies in each eye. In addition, a new Monovision Dominance Invert function enables surgeons to instantly switch eye dominance during a consultation, allowing patients to compare different monovision configurations and better understand how each approach may impact their daily vision.”

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Launch of new pretest for VR-powered diagnostic headset

Heru announced the U.S. launch of the PretestPro on its Heru Prime wearable platform. PretestPro runs four pretest exams in 90 seconds. According to the company’s press release, “PretestPro leverages virtual reality (VR) and eye tracking to capture multiple tests in a single, guided workflow that produces a consolidated, quantitative report of the results to replace subjective, manual testing. Patients are guided to maintain fixation by Nora, Heru’s patient-friendly fixation target, while PretestPro runs four critical pretesting eye exams, including 8-point suprathreshold, near cover test, extraocular motility (EOM), and quantitative pupillometry including RAPD and PERRLA status.”

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Company news

Tarsus announced that it has completed its previously announced acquisition of Alkeus Pharmaceuticals. With the completion of the acquisition, Tarsus adds worldwide rights to ALK-001—a new, investigational, late-stage molecular entity designed to reduce the accumulation of toxic dimers while preserving the normal visual cycle—which is currently being evaluated in the global NORTHSTAR Phase 3 trial, with topline data anticipated in 2029.

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ASCRS news and events

• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2026. Register for the next event, October 8, in New Orleans, Louisiana.
• ASCRS Annual Meeting: Hotel rooms are now available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location.
• eyePAC: Support eyePAC, ASCRS’ political action committee (PAC), which helps protect cataract surgery and preserves surgeons’ ability to deliver high-quality care.*

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EyeWorld article of the week

Ophthalmologists may encounter different subtypes of glaucoma, and an article in the Summer issue of EyeWorldhighlights this. In “Traumatic glaucoma: causes, timing, and management,” two physicians discuss when it occurs, diagnosis, and risk factors. Read the article.

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Research highlights

• A multicenter, retrospective, interventional cohort study, published in the Journal of Cataract & Refractive Surgery, sought to evaluate the influence of preoperative astigmatism magnitude and axis on the selection between non-toric and low-powered trifocal toric IOLs and their comparative refractive outcomes. The study analyzed consecutive eyes designated for non-toric (T00) or low-powered toric (T20) trifocal IOLs based exclusively on Barrett Toric Calculator recommendations. Outcomes included preoperative corneal astigmatism (magnitude and axis), estimated residual astigmatism, and postoperative manifest astigmatism, evaluated with double-angle and linear distribution plots. The cohort comprised 1,628 eyes (T00: 786; T20: 842). The authors noted that the calculator’s recommendation between T00 and T20 varied continuously based on preoperative magnitude and axis. “Despite the T20 group having significantly higher preoperative corneal astigmatism (P<0.001), postoperative manifest astigmatism was statistically equivalent between groups (T00: 0.26±0.26 D vs. T20: 0.24±0.26 D; P=0.634). No significant differences were observed in visual acuity, manifest refraction spherical equivalent, safety, or efficacy indices (P>0.05). However, the T00 group demonstrated higher estimated than achieved postoperative astigmatism (0.33±0.16 D vs. 0.26±0.26 D), whereas the T20 group showed lower estimated than achieved astigmatism (0.10±0.08 D vs. 0.24±0.26 D).”
• A prospective, multicenter, non-randomized pivotal investigational device exemption trial, published in Ophthalmology Glaucoma, evaluated 24-month safety and effectiveness of excimer laser trabeculostomy combined with phacoemulsification in patients with mild-to-moderate primary open angle glaucoma (POAG). Patients underwent phacoemulsification with IOL implantation followed by excimer laser trabeculostomy (ELIOS System, Bausch + Lomb) and were followed for 24 months. The study had coprimary endpoints of proportion of patients achieving ≥20% reduction in unmedicated meandiurnal IOP (DIOP) from baseline at months 12 and 24 (performance goals >79% and >68.5%) and mean change in unmedicated DIOP at the same timepoints (performance goals ≤–7.2 and ≤–6.15 mm Hg). A total of 318 patients underwent the procedure (mean ± SD age, 70.3±7.3 years; medicated IOP at screening, 17.05±3.01 mmHg; unmedicated DIOP at baseline, 24.53±2.51 mm Hg). Both coprimary endpoints were met at months 12 and 24: a ≥20% reduction in unmedicated DIOP was achieved by 84.2% and 76.1% of patients (P=0.0116 and P=0.0018 vs. performance goals), respectively, and the mean ± SE change in unmedicated DIOP was –8.17±0.21 mm Hg and –7.35±0.22 mm Hg (both P<0.0001 vs. performance goals), respectively. Mean DIOP decreased to 15.98 mm Hg at month 12 and 16.76 mm Hg at month 24. At month 23, 82.0% of patients were medication-free. No intraoperative adverse events occurred during the ELIOS procedure, and the postoperative safety profile in this population was consistent with that expected following phacoemulsification alone, the authors noted.

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Product news

• Rayner announced the expansion of its flagship spiral IOL platform with the introduction of RayOne Galaxy Hydrophobic, which it will launch at ESCRS 2026.

*Contributions to eyePAC are entirely voluntary and are not tax deductible. Only ASCRS members who are citizens or legal residents of the United States may contribute. eyePAC must obtain, maintain, and report the name, address, occupation, and employer of each contributor who gives more than $200 in a calendar year.

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