Autologous stem cell therapy to treat dry AMD

The National Eye Institute (NEI) announced that a patient with advanced dry AMD has received an autologous stem cell therapy “patch” as an investigational treatment, the first performed in the U.S. This research, according to the NEI, is currently in a Phase 1/2a clinical trial evaluating safety. This step is the culmination of 10 years of research, NEI reported. It involved the patient’s blood cells being converted to induced pluripotent stem cells and programming them to become retinal pigment epithelial cells.

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Topline results from Phase 3 trial for GA therapy

Iveric Bio shared topline results from its Phase 3 clinical trial evaluating Zimura (avacincaptad pegol), an investigational therapy for geographic atrophy (GA). According to the company’s press release, the prespecified primary endpoint was met with a 14.3% reduction in GA area over 12 months. The study showed a favorable safety profile with the treatment as well. The company plans to submit an NDA to the FDA within the first quarter of 2023.

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Update on Phase 3 myopia progression clinical trial

The final patient follow-up visit has been completed for primary analysis in Vyluma’s pivotal Phase 3 Childhood Atropine for Myopia Progression (CHAMP) clinical trial. This study, according to the company’s press release, was designed with input from the FDA to evaluate the safety and efficacy of NVK002 drops as a possible treatment for progressive myopia in children. Primary analysis readout is expected later this year with the possibility for a regulatory submission in 2023. The company described NVK002 as a proprietary, investigational, preservative-free, nightly drop of low-dose atropine that, if approved, would be the first-in-class pharmaceutical treatment for pediatric myopia progression. The CHAMP study is a three-arm, randomized, double-masked, placebo-controlled study that involved a 3-year study period to evaluate safety and efficacy and a rerandomized, masked 1-year study period after cessation of therapy.

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FDA accepts NDA application for investigational dry eye therapy

Bausch + Lomb and Novaliq announced that the FDA accepted their NDA filing for NOV03 (perfluorohexyloctane) as a first-in-class eye drop for treatment of signs and symptoms of dry eye associated with MGD. The PDUFA date is June 28, 2023.

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ASCRS news and events

• 2023 ASCRS Annual Meeting: The call for abstract submissions for the 2023 ASCRS Annual Meeting is open now through October 14.
• EyeWorld magazine: Articles from the September issue of EyeWorld continue to be posted online. To flip through the full issue, click here.

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Research highlights

• Safety and efficacy over a 3-year period after implantation of two second-generation microbypass stents (iStent inject, Glaukos) was reviewed in a retrospective study published in Clinical Ophthalmology. The study was based on data from eight surgeons in Australia and included a total of 273 eyes that had iStent inject with phacoemulsification and 36 months of follow-up. At 36 months, compared to preoperative baseline, the mean IOP had decreased by 15.5% with 70.3% of eyes achieving an IOP of 15 mm Hg or less. The mean medication burden also decreased by 68.5% with 71.4% of eyes remaining medication-free. The percentage of eyes on three or more medications decreased from 22.3% preop to 6.2% in the 3-year follow-up period. The authors observed significant IOP and medication reductions across different glaucoma subtypes. There were few adverse events, according to the investigators, with eight eyes needing filtering surgery in the 3 years of follow-up. The authors concluded that these results “[underscore] the real-world relevance and efficacy of iStent inject implantation for glaucoma treatment.”
• Long-term efficacy and safety of an iris-fixated, foldable, anterior chamber phakic IOL (Artiflex, Ophtec) was described in two studies published in the Journal of Cataract & Refractive Surgery. One study included 76 eyes (40 patients) that had a mean follow-up of 10 years. In this group, 76% of eyes achieved a UDVA of 20/40 or better and 39% gained 1 or more lines of CDVA; no eyes lost two or more lines of CDVA. At final follow-up, 61% of eyes were within 0.5 D of their spherical target, and 76% were within 1 D. Ninety-five percent of eyes had 1 D or less of postop astigmatism, and 61% were within 15 degrees of intended axis at the final follow-up. Mean endothelial cell loss at final follow-up was 12.2±12.5%, and IOP was stable. Two eyes (2.63%) developed a cataract after 10.3 years. A second study evaluated the stability, predictability, safety, efficacy, and cumulative probability of success of these IOLs at 5, 10, and 15 years of follow-up. This research found that at 5, 10, and 15 years of follow-up, 100%, 95.6%, and 81.6%, respectively, were within ±1.00 D of spherical equivalent target. Both studies concluded that this IOL was safe and efficacious over the long term.

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