Enrollment complete in MIGS pivotal trial

Elios Vision announced that it has completed enrollment in its pivotal trial evaluating the ELIOS procedure, in combination with cataract surgery, for more than 300 patients with mild to moderate glaucoma. According to the company, the ELIOS procedure is implant-free and uses excimer laser technology to create microscopic openings in the trabecular meshwork to re-establish aqueous outflow. The ELIOS technology has the CE mark in Europe for treatment of glaucoma with or without cataract surgery.

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Acquisition of dry eye drop

Bausch + Lomb announced that it will acquire XIIDRA (lifitegrast ophthalmic solution), a topical non-steroidal drop approved for treatment of signs and symptoms of dry eye, from Novartis. Bausch + Lomb will also acquire two investigational products from Novartis: libvatrep (SAF312), a compound in Phase 2b research for chronic ocular surface pain, and AcuStream, a dosing technology. According to the company’s press release, these acquisitions will be made for up to $2.5 billion.

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Two-year results post-cilio-scleral glaucoma procedure

Ciliatech announced 2-year results from its clinical trial evaluating its Cilia-scleral Interposition Device (CID), including that it showed stable IOP over time. Most patients, according to the company’s press release, no longer needed to take topical glaucoma drops postop (90%), and there were no treatment failures. The company also reported that 95% of patients achieved an IOP of 21 mm Hg or lower; 81% were below 18 mm Hg. The company reported that it plans to have its preliminary results confirmed by other surgeons (so far the company’s studies have been conducted by a single surgeon) and in other glaucoma patient populations.

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Positive topline results from Phase 2 study of retinitis pigmentosa treatment

Aldeyra Therapeutics announced positive topline results from its Phase 2 study of ADX-2191 (methotrexate injection) for treatment of retinitis pigmentosa. According to the company’s press release, relative to baseline, ADX-2191 showed a statistically significant improvement in retinal function. Among the reported findings, CVA and low-light visual acuity were significantly improved, time to retinal response on electroretinography was significantly improved, and retinal sensitivity was significantly improved. The treatment was well tolerated with no reported safety concerns. The company plans to move into a Phase 2/3 clinical trial after discussion with regulatory authorities.

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ASCRS news and events

• ASCRS Summer Meeting: Save your seat at the ASCRS Summer Meeting in Nashville, Tennessee, August 11–13. Reserve your hotel room by July 14 to receive the discounted meeting rate.
• ASCRS Grand Rounds: A new episode of ASCRS Grand Rounds, presented by the Dean McGee Eye Institute, is available online now.
• ASCRS Joint Committee Webinar: The ASCRS Retina Clinical Committee and the Challenging/Complicated Cataract Surgery Subcommittee collaborated to produce an informative discussion on complex cataract cases with retina pathology or history of retina surgery.

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Research highlights

• Three-year safety and efficacy of Clareon single-piece IOLs (Alcon) were reported in a prospective, multicenter, single-arm study that was published in the Journal of Cataract & Refractive Surgery. The study, which included 19 sites where Clareon IOLs were implanted binocularly, had 183 patients complete the trial with 3 years of follow-up. At 1 year, 99.5% of eyes achieved monocular CDVA of ≤0.3 logMAR, and at 3 years, the mean monocular CDVA was –0.032 (93.4% of eyes achieved CDVA logMAR 0.1 or better at this time point). All eyes had grade 0 glistenings. The majority of eyes (92.9%) had no PCO or insignificant PCO.
• A randomized clinical trial sought to evaluate safety and efficacy of ab interno canaloplasty (ABiC) compared to gonioscopy-assisted transluminal trabeculotomy (GATT) in patients with open angle glaucoma. Published in the British Journal of Ophthalmology, the investigators randomized 38 patients to ABiC and 39 to GATT; both groups presented with similar demographic and ocular characteristics, according to the study. Ninety-two percent of participants completed 12 months of follow-up, and at this time, mean IOP was 19.0±5.2 mm Hg in the ABiC group and 16.0±3.1 mm Hg in the GATT group. The number of glaucoma medications in use was lower in the GATT group (0.6±1.2), compared to 0.9±1.3 in the ABiC group. Cases were considered a surgical success at 12 months in 56% of ABiC cases and 75% of GATT cases. From a safety standpoint, hyphema occurred in 87% of GATT cases and 47% of ABiC cases; suprachoroidal effusion was also more common in GATT (92% vs. 71% in ABiC). Three eyes in the ABiC group needed additional glaucoma surgery compared to one eye from the GATT group.

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