New trifocal receives FDA approval

BVI announced FDA approval of its FINEVISION HP trifocal IOL. This third-generation version of the FINEVISION HP IOL is designed, according to the company, to maximize light distribution and minimize visual disturbances. It also has a double C-loop, four-point haptic design for long-term stability and centration. The company stated that it will roll out availability of this lens in the U.S. over the coming year, having recently invested in capacity expansion to meet expected market demand.

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Robotic system completes its first cataract surgery

Horizon Surgical Systems announced the world’s first-in-human cataract surgery performed using the Polaris platform with operation by cataract surgeon Uday Devgan, MD, FACS. The Polaris system, according to the company’s press release, uses “AI-driven visualization with micro-robotic control.” The hope with this technology is to “reduce variability, increase precision, and integrate seamlessly into established operating room workflows,” according to the company. The company plans for more in-human procedures to demonstrate the system’s capabilities with the goal of obtaining FDA approval in the future.

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Interim results from first-in-human bimatoprost-IOL system

SpyGlass Pharma announced interim, 24-month data from the first-in-human study of its Bimatoprost Drug Pad-IOL System. According to the company’s press release, patients who have glaucoma who received this implant achieved a 42% reduction in mean IOP compared to baseline, 100% were off all topical IOP-lowering drops, and 100% achieved 20/30 or better BCVA. The drug-eluting IOL system was well-tolerated; all adverse events were related to the cataract procedure, not the IOL system. There were no serious adverse events.

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Reproducible regenerative effects observed in preclinical glaucoma model

NurExone announced preclinical results for its ExoPTEN as a treatment under investigation for glaucoma. The ExoPTEN, an exome-based nanodrug delivery system, was delivered in low and high doses via an extrachoroidal injection and showed, according to the company, a reproducible, dose-dependent regenerative effect on the optic nerve in an animal glaucoma model. The ExoPTEN has previously showed the ability to preserve retinal ganglion cells.

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Phase 3 program begins for intravitreal insert treating wet AMD, DME

EyePoint Pharmaceuticals has begun Phase 3 clinical trials for DURAVYU (vorolanib intravitreal insert), under investigation for treatment of wet AMD and DME. Patient dosing is expected to begin in the first quarter of 2026. The Phase 3 trial for DME is a non-inferiority trial, comparing DURAVYU dosed every 6 months to aflibercept (control). The primary endpoint will be change in BCVA from baseline to 52 and 56 weeks. About 240 patients will be enrolled. The company also announced new preclinical data that shows the ability of DURAVYU to inhibit VEGF-mediated vascular permeability and interleukin-6-mediated inflammation, which are contributors to both wet AMD and DME.

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ASCRS news and events

• ASCRS Live!: The final session of the year for this educational dinner series, which visited several cities across the U.S. in 2025, will take place in Dallas on November 13.
• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13, 2026. Get involved with the meeting by submitting a case video—learn more.
• ASCRS Grand Rounds: The latest episode of ASCRS Ground Rounds, presented by Eastern Virginia Medical School, is available on demand.

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Research highlights

• The uveal and capsular biocompatibility of a new IOL material (crosslinked polyisobutylene) was compared to a commercial reference IOL material in a rabbit eye model. In the prospective, comparative, randomized study, the authors found no difference in either uveal or capsular biocompatibility between the study and control IOL materials upon biomicroscopy, Miyake-Apple posterior view, or histopathologic examination. They reported a lower incidence and mean group severity of Soemmerring’s ring in the test IOL group, but they ultimately concluded that both groups “demonstrated the typical, expected ocular reactions of PCO and Soemmerring’s ring after IOL implantation in rabbit eyes.” The test material was non-inferior to the reference IOL. This study is published in the Journal of Cataract & Refractive Surgery.
• A Phase 3 study published in the British Journal of Ophthalmology compared the safety and efficacy of a new preservative-free bimatoprost 0.01%/timolol 0.1% fixed-combination eye gel to a bimatoprost 0.03%/timolol 0.5% fixed-combination drop for patients with open-angle glaucoma or ocular hypertension. The lower concentration eye gel was found to be safe and effective, as it resulted in a mean change in IOP from baseline to week 12 of −10.96±3.43 mm Hg, compared to −11.14±3.56 mm Hg with the drop. The safety between the gel and drop were comparable; no patients in the gel group discontinued the study due to treatment-related adverse events, while eight patients who were on the drop did discontinue due to treatment-related adverse events.

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Product news

• Iantrek has begun its commercial launch of AlloFlo Uveo, a surgical treatment for glaucoma targeting the uveoscleral pathway.

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