FDA approves first eye drop to treat presbyopia
The US FDA has approved Vuity, an pilocarpine hydrochloride ophthalmic solution 1.25% for the treatment of presbyopia, on October 28. AbbVie vice chairman and president Michael Severino, MD, said that Vuity is a "first-of-its-kind once-daily eye drop that [they] believe will change the way people and their eye doctors approach presbyopia."
Vuity is a daily prescription eye drop that takes effect in as little as 15 minutes and can last up to 6 hours, improving near and intermediate vision without affecting distance vision, the press release states. The solution can adjust rapidly to the tear film's pH by delivering pilocarpine through pHast(TM) technology, according to the release.
Two phase-3 clinical studies, GEMINI 1 and GEMINI 2, formed the basis of FDA approval. The studies found statistically significant improvement of at least three lines in near-vision in low-light conditions without loss of more than one line of distance vision on day 30 at hour 3. The clinical studies showed no serious adverse events. Headache and ocular redness, both nonserious adverse events, were observed in about 5% of the subjects.
Source: https://news.abbvie.com/news/press-releases/us-food-and-drug-administration-appr
Gene therapy boosts Parkinson disease drug benefits
A Northwestern Medicine preclinical study shows that gene therapy targeting the substantia nigra, the small brain region where dopamine-releasing neurons reside, substantially increases the benefits of levodopa in treating late-stage Parkinson disease.
Levodopa, a drug used to treat Parkinson disease, has been less effective in late-stage symptoms due to the unavoidable loss of dopamine-releasing neurons. By restoring the neurons' ability to convert levodopa to dopamine, the gene therapy allows levodopa to recreate a healthy brain's environment and removes the aberrant brain activity which causes movement difficulty.
Through advanced genetic tools, proponents of the study showed how damage to the mitochondria inside the dopamine-releasing neurons is enough to trigger a sequence of events that accurately recapitulates what happens to brain circuits in Parkinson disease, thereby explaining how dopamine-releasing neurons are lost in the disease. Published in Nature, the study and its findings in mice may help identify humans in the earliest stages of the disease, aid in the development of therapies to slow progression, and treat late-stage Parkinson disease.
D. James Surmeier, lead study author and neuroscience chair at Northwestern University Feinberg School of Medicine, said that this is the first "definitive evidence that injury to mitochondria in dopamine-releasing neurons is enough to cause a human-like parkinsonism in a mouse." The study resolves the long debate of whether mitochondrial damage was a cause or consequence of Parkinson disease, said Surmeier, and allows them now to focus on developing therapies to preserve neuron function and slow their loss.
The study also provides a model of Parkinson disease before clinical symptoms appear, allowing researchers to observe events in the brain well ahead of movement difficulty, develop tests to identify people at risk for a Parkinson disease diagnosis 5 or 10 years in advance, and allow an early start to therapies that could alter disease progression, Surmeier says.
Northwestern's Patricia Gonzalez-Rodriguez, Enrico Zampese, Kristen Stout, Jamie Guzman, Ben Yang, Tatiana Tkatch, Ema Ilijic, and Paul Schumacker coauthored the study. The Michael J. Fox Foundation, the JPB Foundation, the IDP Foundation, the Flanagan Foundation, and the National Institutes of Health supported the research.
Source: https://news.northwestern.edu/stories/2021/11/gene-therapy-boosts-parkinsons-dis
Researchers test Molnupiravir for COVID-19 prevention
Montefiore Health System and Albert Einstein College of Medicine take part in a newly launched international phase 3 clinical trial to investigate whether molnupiravir, Merck's antiviral pill now approved in Britain for treating COVID-19, can prevent the disease in unvaccinated individuals exposed to people with COVID-19 infections.
People with mild or moderate cases of COVID-19 treated with molnupiravir reduced their risk of hospitalization and death by approximately 50%, Merck reports. After getting approval in Britain, Molnupiravir is the first oral drug approved for treating COVID-19. Molnupiravir works by deceiving viral cells into absorbing the drug's molecules and converting them into defective RNA building blocks which are then used by the viral enzymes to construct new genetic material incapable of reproducing the virus.
The CDC estimates that unvaccinated people living with a person with the COVID-19 delta variant have between an 80% and 100% chance of being infected, regardless of age or preexisting conditions, said Barry Zingman, MD, principal investigator for the New York Site.
Monoclonal antibody (mAb) therapies are the only drugs currently used to prevent COVID-19, but these must be infused into the bloodstream in a clinic. Once approved, the more accessible molnupiravir could have a bigger impact than mAb therapies as these could work across different viral variants.
The randomized, double-blind, and placebo-controlled study will include 1,300 participants at 114 sites globally. Half the participants will be given four molnupiravir pills twice daily for 5 days, while the control group will take the placebo. Participants are tested for COVID-19 2 and 4 weeks after the start of the treatment. As the only New York site in the trial, the Montefiore-Einstein site will enroll between 10 and 20 individuals all age 18 or older, completely unvaccinated, exhibit no COVID-19 symptoms, and share a household with a person who tested positive for COVID-19 within the previous 5 days.
Source: http://www.montefiore.org/body.cfm?id=1738&action=detail&ref=2063