Study: long-term efficacy of uveoscleral outflow enhancement for glaucoma

Iantrek announced publication of 2-year results from a prospective clinical trial that showed long-term efficacy of the company’s cyclodialysis procedure with “bio-reinforcement,” also described as a “bio-interventional platform for uveoscleral outflow enhancement.” The procedure was performed on patients with open angle glaucoma and combined with cataract surgery, though it is approved as a standalone procedure. In the study published in Ophthalmology Science, 74% of eyes achieved a 20% or greater reduction in IOP after 2 years with the same or fewer glaucoma medications; mean IOP was reduced by 34% from baseline, and IOP-lowering medication use decreased by more than 60%. According to the company, the FDA-cleared technology allows surgeons to “address the previously untapped potential of the uveoscleral outflow pathway.” The company began a pre-commercial launch in 2024 and will broaden its commercial launch in the third quarter of this year.

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FDA grants expanded indication for fluocinolone acetonide intravitreal implant

ANI Pharmaceuticals announced that the FDA expanded its label for ILUVIEN (fluocinolone acetonide intravitreal implant) to include treatment of chronic non-infectious uveitis in the posterior segment, in addition to the current indication of diabetic macular edema. ILUVIEN already had both indications approved in 17 European countries, according to the company’s press release.

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First patient dosed in Phase 1/2 gene therapy trial targeting Stargardt disease

SpliceBio announced that its first patient in a Phase 1/2 study has been dosed with its SB-007 gene therapy, a dual adeno-associated viral vector treating mutations in the ABCA4 gene, causing Stargardt disease. This, according to the company’s press release, is the most common form of juvenile macular degeneration, and it has no currently approved treatments. The gene therapy is designed with the hope of restoring expression of the full length of the ABCA4 protein, regardless of the mutation, according to the company’s CEO and co-founder.

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Merger complete

Kalaris Therapeutics completed its merger with AlloVir. It will operate under the name Kalaris Therapeutics. According to the company’s press release, Kalaris is developing a novel, differentiated anti-VEGF for retinal diseases that it hopes will be more effective and longer lasting; some data from its ongoing Phase 1 clinical trial is expected to be reported in the second half of this year.

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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. Find the most up-to-date information on the Real-Time Program here.
• SightLine at ASCRS: This is a new day-long meeting April 24, ahead of the ASCRS Annual Meeting, for all commercial stakeholders in ophthalmology to learn about and collaborate on technologies and care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 24 from 1:00–5:30 p.m. in Los Angeles ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• 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. Tune in each week through April 2025 for a new video.

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Research highlights

• A meta-analysis sought to evaluate the complication rates of different IOL placement methods in the setting of inadequate capsular support. The methods included in the analysis were: anterior chamber (AC) placement, iris fixation (prepupillary or retropupillary with an iris claw IOL or iris suturing), and scleral fixated (sutured or sutureless). Studies that compared the results of two or more different placement methods were included in the meta-analysis, resulting in 15 total studies reporting results on 1,247 eyes. The authors reported that the overall complication rate was “nonsignificantly” lower in the iris fixation group compared to AC placement and scleral fixation. Transient corneal edema was the most common complication with AC placement, while vitreous hemorrhages were more common with scleral fixation techniques. IOL decentration and dislocation was more common with scleral fixation techniques as well. The authors concluded that the “risks associated with particular techniques should be taken into account in preoperative counseling and planning postoperative treatment.” The paper is published in the Journal of Cataract & Refractive Surgery.
• A retrospective cross-sectional study published in the American Journal of Ophthalmology evaluated automated epithelial thickness metrics in identifying subclinical keratoconus (SKC) through epithelial thickness pattern comparisons with normal controls (n=100), SKC (n=50), and manifest keratoconus (KC) (n=50). Epithelial mapping was performed using AS-OCT (Avanti RTVue XR, Optovue). The authors found “no differences between control and SKC groups in any regional OCT epithelial thickness parameter.” They noted “relational epithelial thickness metrics, only superonasal-inferotemporal value differences” that reached statistical significance between the control and SKC groups, but there was “limited performance in differentiating groups.” Stromal thickness values were significantly different between the SKC and control groups. With this data, the authors concluded that epithelial thickness patterns are not effective as a primary metric for identifying SKC.

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Product news

• Harrow began an initiative—VEVYE Access for All—available through its pharmacy partner PhilRx, that “guarantees access to VEVYE (cyclosporine ophthalmic solution) 0.1% for eligible patients and health plans for $59.”
• Bausch + Lomb launched a new orthokeratology lens fitting system, Arise, which is designed to streamline the lens design process.

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