Enrollment begins for Phase 1b/2 study for nAMD treatment

Kalaris Therapeutics announced that it began enrollment for its Phase 1b/2 ascending dose study to assess the safety and efficacy of TH103 for treatment of neovascular age-related macular degeneration (nAMD). The study will enroll up to 80 patients with nAMD who will receive four initial monthly injections at different dose levels. The primary timepoint for safety and efficacy analysis is 1 month after the last injection. An extension phase of the study will continue for patients in the months following. Initial data is expected in the second half of 2026. TH103 is described by the company as a “dual-action investigational therapy engineered to potentially provide increased and longer-lasting anti-VEGF activity to treat exudative and neovascular retinal diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).”

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Study: real-world data from presbyopia-correcting IOL

Real-world data was recently presented from an ongoing, multicenter, single-arm, single visit, observational study with the TECNIS PureSee IOL (Johnson & Johnson), an extended depth of focus lens, which the company described in its press release as a “purely refractive, presbyopia-correcting IOL.” The study, which was conducted at nine sites in Europe and Asia-Pacific, includes data from 95 patients. It found that the mean postop MRSE among these patients was 0.10±0.41 D. Mean logMAR binocular best-corrected distance visual acuity, distance-corrected intermediate visual acuity at 66 cm, and distance-corrected near visual acuity at near 40 cm were –0.09±0.08, 0.12±0.10, and 0.24±0.14, respectively. Most patients reported glasses use as “none” or “a little of the time” with this lens—96.8% for distance, 94.7% for intermediate, 58.9% for near, and 86.3% overall. Patient satisfaction (“mostly” or “completely”) with their vision was 93.7%, 94.7%, 61.1%, and 91.6% for distance, intermediate, near, and overall, respectively. Nearly 94% of patients would recommend the lens to their family and friends.

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Publication of presbyopia-correcting IOL pivotal trial data

Bausch + Lomb announced the publication of its U.S. pivotal trial results for the enVista Envy IOL, which it described as a “novel full visual range intraocular lens.” The study compared the visual, refractive, and patient-reported outcomes with the enVista Envy IOL (n=332) and the enVista monofocal IOL (n=169). The Envy lens demonstrated non-inferiority to the monofocal IOL for monocular CDVA and was statistically superior for monocular DCIVA and DCNVA. The Envy lens also demonstrated better binocular UIVA, DCIVA, UNVA, and DCNVA compared to the monofocal lens. Consistent visual acuity of ~0.1 logMAR from –1.50 to –2.50 D was observed with the Envy lens. Mesopic contrast sensitivity without glare was “less than the minimum detectable difference,” according to the company’s press release. The Envy lens is designed with “ActivSync Optic intelligent energy distribution, which optimizes vision in many lighting conditions,” according to the company. The study was published in the American Journal of Ophthalmology.

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Study: cataract turnover time reduced with technology

Alcon announced presentation of a study at the 2025 ESCRS Congress that evaluated console setup and full procedure turnover for cataract surgery using its UNITY Vitreoretinal Cataract System compared to its CONSTELLATION Vision System and CENTURION Vision System with ACTIVE SENTRY. Researchers found that the UNITY system reduced cataract surgery turnover time by 6%. It also was associated with reduction in total energy in the eye (35%) and less ultrasound time (8%), according to the company’s press release.

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Systematic review and meta-analysis confirm long-term safety, efficacy of glaucoma treatment

Sight Sciences announced presentation of data and publication of a systematic review and meta-analysis of its OMNI Surgical System for the treatment of elevated IOP due to open-angle glaucoma. The presentation took place at the ESCRS Congress, and the data were published in the European Journal of Ophthalmology. The study found that both standalone and combined treatments with the OMNI system, as well as the prior Visco360 and Trab360 systems, achieved significant, long-term IOP reductions and a reduction in medication use. The analysis included 29 publications (27 with clinical outcomes and two with economic outcomes). The mean IOP in the studies over 12 months when OMNI was performed standalone or combined with cataract surgery was less than 18 mm Hg. IOP-lowering medications decreased from 0.9–3.4 at baseline to 0.1–2.2 at month 12 and continued out to 24–36 months. Adverse events, according to the study, were mild and transient.

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Implant cuts GA lesion growth by 53%

Inflammasome Therapeutics announced that its K8 (kamuvudine) implant for treatment of geographic atrophy (GA) reduced lesion growth by 53% in 3 months. According to the company’s press release, this is the first in-human clinical trial evaluating K8. The ongoing study will include 30 patients to evaluate safety and efficacy among three dose cohorts over 6 months; untreated fellow eyes served as the control. The 53% reduction was observed in the low-dose implant cohort (n=10). BCVA increased by a mean of 1.4 ETDRS letters in treated eyes, while untreated control eyes lost an average of 1.9 ETDRS letters. The mid-dose cohort completed enrollment, and the high-dose cohort is enrolling.

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Company news

• Ollin Biosciences announced its launch with its lead clinical-stage program for OLN324, a VEGF/Ang2 bispecific antibody for treatment of wet AMD and DME, and its second program for OLN102, a first-in-class TSHR/IGF-1R bispecific antibody for treatment of thyroid eye disease and Graves’ disease. In its press release, the company stated that it is focused on “acquiring and developing best-in-disease therapies for vision-threatening diseases.”

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ASCRS news and events

• Business of Refractive Cataract Surgery (BRiCS) 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 Cincinnati on September 25.
• 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.

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Research highlights

• The differences between conventional keratometry (K) values and total keratometry (TK) values before and after keratorefractive lenticule extraction (KLEx) was evaluated in a retrospective exploratory comparative study. The study also evaluated correlations between central corneal thickness and other variables, such as amount of laser vision correction. The study published in the Journal of Cataract & Refractive Surgery found significant differences between the K values and TK values both preop and postop. A strong relationship between amount of reduction in central cornea thickness and the K and TK values after KLEx was observed as well. There was also a strong association between the amount of laser vision correction and the difference between K values and TK values after KLEx. According to the authors, the study “demonstrated that TK-values provide a more comprehensive assessment of corneal power, especially after KLEx, where the incorporation of posterior corneal surface becomes increasingly significant.” The authors noted that the correlations found in the study “suggest that patients with higher degrees of preexistent myopia or significant amount of laser ablation require special consideration in their refractive corneal assessments.”

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Product news

• Lions World Vision Institute expanded its OptiGraft CAIRS (Corneal Allogenic Intrastromal Ring Segments) service to include asymmetrical laser-cut CAIRS, which it stated in its press release “broadens the therapeutic options for corneal surgeons managing advanced cases of keratoconus and other corneal ectatic disorders.”
• Haag-Streit launched the Elara 900 and the Refractor 900 internationally at the 2025 ESCRS Congress and will debut the new technologies in the U.S. at the upcoming 2025 AAO Annual Meeting.
• Visionix is debuting its VX 40 Couture, which provides comprehensive information (spherical power, cylinder, axis, prism, and optical center positioning) in 30 seconds.
• Sagent Pharmaceuticals entered the ophthalmic market with the launch of its Travoprost Ophthalmic Solution, USP 0.004%.

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