A weekly roundup of ophthalmic news from around the web.
Ophthalmic dispensers are now devices and not drugs, says the FDA. Ophthalmic dispensers (e.g., eye droppers and eye cups) packaged in combination with an ophthalmic drug have been regulated historically as drugs by the FDA. However, based on an April 2021 US Court of Appeals decision, the FDA issued updated its guidance this month that any ophthalmic dispenser deemed to be a device will be regulated as a device and not a drug. Manufacturers of combination dispenser-medication products will be given 12 months to comply with these new regulations. US Food and Drug Administration
Antabuse as a treatment for retina pigmentosa? Mouse model data show promise. Researchers at the University of California Berkeley found that giving disulfiram (Antabuse) to mice with retinoic acid (RA)–induced retinal activity improved their vision. Disulfiram, a retinoic acid receptor inhibitor, is a longstanding treatment for alcohol abuse, and retinoic acid has been studied as a possible cause of retinitis pigmentosa and related conditions. Dr. Richard Kramer, lead investigator of the mouse study and the retinoic acid research program, said “If a vision-impaired human were given disulfiram, and their vision got better, even a little bit, that would be a great outcome in itself. But it would also strongly implicate the retinoic acid pathway in vision loss, and that would be an important proof of concept that could drive new drug development and a whole new strategy for helping to improve vision.” Small studies in humans are set to begin later in 2022. University of California Berkeley, Science Advances
Revised UK guidelines for glaucoma recommend SLT for ocular hypertension. In its January 2022 update to UK glaucoma diagnosis and management guidelines, the National Institute for Health and Care Excellence (NICE) added a new recommendation for the use of 360° selective laser trabeculoplasty (SLT) as first-line treatment for patients with either newly diagnosed ocular hypertension with IOP of ≥24 mm Hg or chronic open-angle glaucoma, especially if they seem to be at risk for visual impairment. A separate evidence review for this new guidance can be downloaded from the NICE website. National Institute for Health and Care Excellence
New study links psychologic distress and visual impairment in older adults. Visual impairment’s effect on psychologic distress (PD) (e.g., anxiety, depression, bipolar disorder) in older persons (aged ≥65 years) were studied in a Taiwanese general population cohort. Ten percent of the cohort had diagnosed PD, but that subgroup had significantly greater rates of blindness and low vision than those without PD. Conversely, having blindness conveyed a greater risk of developing PD over the long term; smoking, lower education levels, and low body mass index also were risk factors. Given these results, the authors propose that “early referral for [visual impairment] examination and treatment should be implemented in clinical practice, particularly among patients suffering from psychologic problems.” Journal of Clinical Medicine
Good outcomes are seen with long-term pegcetacoplan injections for GA. There is currently no FDA-approved treatment for geographic atrophy (GA), but pegcetacoplan, already approved for paroxysmal nocturnal hemoglobinuria, has the potential to be that treatment due to promising 18-month data. Results from the phase 3, sham-controlled, 36-month DERBY and OAKS trials found that pegcetacoplan given either every month or every other month led to significant reductions in GA monthly lesion growth. Full study results will be presented at upcoming medical meetings, and a new drug application is expected to be submitted to the FDA in the 2nd quarter of 2022. MedCityNews, Globe Newswire