FDA accepts NDA for ‘first-of-its-kind’ anti-inflammatory for dry eye

Novaliq announced FDA acceptance of its NDA for CyclASol, a cyclosporine ophthalmic solution, which is based on the company’s EyeSol water-free technology, for the treatment of signs and symptoms of dry eye. The company stated that the PDUFA target action date for the decision on the NDA is set for June 8, 2023.

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Positive Phase 3 results for investigational presbyopia therapy

Eyenovia announced positive Phase 3 results from its VISION-2 study of MicroLine, an investigational, topical, on-demand treatment for presbyopia. The treatment, a 2% pilocarpine micro-array print (MAP), was compared to placebo. Both the investigational drug and placebo were administered with the company’s Optejet delivery system. In its press release, Eyenovia stated that in evaluable patients, primary endpoints were met with a statistically significant number of participants treated with MicroLine having a 15-letter or more improvement in DCNVA and a “less than 5-letter loss in distance acuity versus placebo in low light conditions at 2 hours post-treatment.” According to the press release, less than 3% of patients experienced adverse events, which the company noted were all mild and/or transient.

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Study: long-term visual outcomes with remote monitoring technology

Notal Vision reported publication of its Analysis of Long-Term Visual Outcomes of ForeseeHome Remote Telemonitoring (ALOFT) study, which is a 10-year, retrospective study. This is the second report from the study, which the company stated specifically focused on early management and clinical research capabilities that could be provided by the ForeseeHome technology. According to the company’s press release, the researchers analyzed data from patients who had alerts with the technology, but the alerts did not result in an immediate wet AMD diagnosis (a false positive). The company explained that the data showed these patients were twice as likely than other dry AMD patients to convert over the same period. Patients who had wet AMD in one eye and dry AMD in the other had a 44% chance of converting to wet AMD over the next 2 years. As stated in the study published in Ophthalmology Retina, “All eyes monitored by ForeseeHome that are fellow to eyes diagnosed with nAMD are at very high risk for future conversion. The predictive value of [false positive] alerts for risk of future conversion in nAMD [fellow eyes] was found to be significantly higher compared to eyes in other subgroups of ALOFT or in comparator trials.”

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Companies partner to create tool to assess fall risk

Sensoria Health and Padula Rehabilitation Technologies announced their partnership to create a tool for healthcare providers to assess patients for fall risk. According to the companies’ press release, this tool, NeurOpTrek, would be the first and only wearable solution for risk of fall assessment. The companies stated that this system would collect gait-related data, which would then be analyzed to determine the patient’s visual potential. The system consists of Sensoria smart socks, the NeurOpTrek app, and a tablet. According to the press release, after assessment, the information is used to help generate “prescription yoked prism lenses to reduce risk of falls.”

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ASCRS news and events

• 2023 ASCRS Educator Award: ASCRS is accepting nominations for its Educator Award, which will be given at the 2023 ASCRS Annual Meeting. Submit a nomination here.
• 2023 ASCRS Annual Meeting: Hotel blocks in San Diego, California, for the Annual Meeting are open now. Early bird registration opens November 21. Learn more.
• EyeWorld magazine: Find the latest quarterly issue of EyeWorld with a focus on “Back to basics” online now. Also take a look at recent EyeWorld Online Exclusives.

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Research highlights

• A new technique for universal fixation of any posterior chamber IOL, iris prosthesis, or capsular tension device, for cases of dislocation or secondary implants, was published in the Journal of Cataract & Refractive Surgery. The technique, authored by Sergey Toropygin, MD, PhD, uses an intrascleral anchoring knot on a reinforced double 9-0 polypropylene suture. The technique does not use conjunctival opening or scleral dissection, the report stated. Several cases were included in the report, followed for up to 6 months. In these cases, UCDVA was significantly improved and IOL positions remained stable. The author concluded that this could be a “simple, effective, and safe alternative to flanged scleral fixation approaches.”
• A paper published in the journal Cornea described use of anterior segment OCT (AS-OCT) and in vivo confocal microscopy (IVCM) to identify and analyze endothelial plaques in order to inform diagnoses of bacterial and fungal keratitis. The authors of the paper stated that endothelial plaques are a sign of fungal keratitis, but they noted that at times, bacterial keratitis can also involve fibrin formation that can resemble endothelial plaques. This can make “distinguishing pathogens with a slit lamp … difficult.” The study included 52 patients with confirmed fungal (n=28) or bacterial (n=24) keratitis with endothelial plaques. The patients had AS-OCT and IVCM. The authors observed that most of the time patients with fungal keratitis had endothelial plaques with a boundary that was unclear and wavy with AS-OCT. With IVCM, there were “unclear cell boundaries and a large number of compactly distributed inflammatory cells in the endothelial layer” in fungal keratitis cases. With AS-OCT, patients diagnosed with bacterial keratitis cases had clear corneal endothelium-endothelial plaque boundaries, and “insufficient endothelial cell boundaries with a large number of visible and scattered inflammatory cell structures were observed through IVCM” in most cases. The authors concluded that AS-OCT and IVCM could be used for early diagnosis of infectious keratitis.

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Product news

• NEXGEL announced that it has developed a new hydrogel patch to treat amblyopia that will be available commercially in the first half of 2023.

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