VUITY Only FDA-Approved Eye Drop to Treat Presbyopia is Now Available

Calendar March 8, 2023 | Posted by admin

Allergan, an AbbVie (NYSE: ABBV) company, today announced that VUITY™ (pilocarpine HCl ophthalmic solution) 1.25%, the first and only eye drop approved by the U.S. Food and Drug Administration (FDA) to treat presbyopia, is now available by prescription in pharmacies nationwide. Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam by an eye doctor (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the U.S. adult population.


“We are pleased to be able to bring this first-of-its-kind treatment to market sooner than expected for the millions of Americans with presbyopia who may benefit from it,” said Jag Dosanjh, senior vice president medical therapeutics, Allergan, an AbbVie company. “This significant innovation in age-related eye health reflects our commitment to advance vision care and expands our leading portfolio of treatments for eye care providers and their patients.”

“Many Americans deal with presbyopia, which typically begins around age 40, by relying on reading glasses or resorting to work-arounds like zooming in on their digital devices to see up close. As an optometrist who also has presbyopia, I’m personally and professionally excited to try VUITY for myself, as well as offer it to my patients with age-related blurry near vision,” said optometrist Dr. Selina McGee, Fellow of the American Academy of Optometry. “With VUITY now available, it is a good time for those who experience age-related blurry near vision to visit their eye doctor for an exam and to discuss their options to manage this common condition.”

Source: https://news.abbvie.com/

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Meat Made Without Any Animals

Calendar December 28, 2022 | Posted by admin

People in lab coats may soon be replacing farm animals. Upside Foods has developed a version of “slaughter-free,” lab-grown meat, which can be made without a single real animal. And now the FDA has approved this chickenless chicken for consumer consumption, meaning we may soon see it in restaurants and grocery stores.

Cultivating meat in a lab is a high-tech process, which involves taking cell samples from an animal and then nurturing them in a “cultivator,” where they grow and multiply into tissue.

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New Drug ‘Lights Up’ Lung Cancer Cells During Surgery

Calendar December 21, 2022 | Posted by admin

To help surgeons with the exacting task of finding and removing lung cancer cells, and sparing healthy tissue, the Food and Drug Administration (FDA) has approved a fluorescent imaging agent that "lights up" lung cancer cells for easier detection. The prescription medication, Cytalux, or pafolacianine, was first approved by the FDA in November 2021 to help detect ovarian cancer during surgery. It received permission for the additional use on Friday.

Purdue ‘Light Up’ Cancer Technology Earns FDA Approval

Now, researchers cite its potential to improve the outcomes of thousands of lung cancer patients. Cytalux, which is given as an intravenous injection to adults prior to surgery, is designed to improve the ability to locate cancerous lung tissue that is normally difficult to detect during surgery, the FDA said. In a study of safety and effectiveness, of the 110 non-small cell lung cancer patients who received a dose of Cytalux and were evaluated under both normal light and fluorescent light during surgery. The FDA said 24% had at least one cancerous lesion detected that was not observed by standard visual inspection or by touch.

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Blood Cancer Therapy Successful in 75% of Trial Patients

Calendar December 13, 2022 | Posted by admin

New data from an ongoing Phase 1/2 clinical trial has revealed an experimental immunotherapy led to successful response rates in 73% of patients suffering from multiple myeloma, a deadly form of blood cancer. Based on this promising data, an application to the US Food and Drug Administration (FDA) has been filed to bring the drug to market.

 

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Elon Musk’s Neuralink expects to start human trials of wireless brain chip in 6 months

Calendar December 2, 2022 | Posted by admin

Elon Musk’s Neuralink Corp expects to start inserting its wireless brain chip into human patients within six months, the US-based company said at an event yesterday.

Neuralink is developing a brain chip implant that it says could enable disabled patients to move and communicate again, which it demonstrated with a video of a monkey typing on a keyboard to order snacks using ‘telepathic typing’ with the chip communicating messages from its brain to a computer. It needs approval from the US Food and Drug Administration (FDA) before it can start clinical trials on people.

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First Cultivated Meat Approved By The FDA

Calendar November 18, 2022 | Posted by admin

A major milestone is currently underway in the realm of cultivated meat. Food scientists have spent decades of research and development crafting new meat to tackle the increasing demand for this produce, reduce environmental degradation, and support animal welfare (via CNN). Now, one company is swiftly on its way to producing some of the country's first cultured protein. Following its first pre-market consultation, the FDA has evaluated the safety of cultivated chicken created by Upside Foods and confirmed that there are no further questions at this time.

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‘Drug Factory’ Implants Could Eliminate Specific Lung Cancer

Calendar September 12, 2022 | Posted by admin

Rice University and Baylor College of Medicine researchers have shown they can seradicate advanced-stage mesothelioma tumor in mice in just a few days with a treatment combining Rice’s cytokine “drug factory” implants and a checkpoint inhibitor drug.

The researchers administered the drug-producing beads, which are no larger than the head of a pin, next to tumors where they could produce continuous, high doses of interleukin-2 (IL-2), a natural compound that activates white blood cells to fight cancer. The study, published online today in Clinical Cancer Research, is the latest in a string of successes for the drug-factory technology invented in the lab of Rice bioengineer Omid Veiseh, including Food and Drug Administration (FDA) approval to begin clinical trials of the technology this fall in ovarian cancer patients.

“From the beginning, our objective was to develop a platform therapy that can be used for multiple different types of immune system disorders or different types of cancers,” said Rice graduate student Amanda Nash, who spent several years developing the implant technology with study co-lead author Samira Aghlara-Fotovat, a fellow student in Veiseh’s lab.

The cytokine factories consist of alginate beads loaded with tens of thousands of cells that are genetically engineered to produce natural IL-2, one of two cytokines the FDA has approved for treatment of cancer. The factories are just 1.5 millimeters wide and can be implanted with minimally invasive surgery to deliver high doses of IL-2 directly to tumors. In the mesothelioma study, the beads were placed beside tumors and inside the thin layer of tissue known as the pleura, which covers the lungs and lines the interior wall of the chest.

“I take care of patients who have malignant pleural mesothelioma,” said Dr. Bryan Burt, professor and chief of Baylor’s Division of Thoracic Surgery in the Michael E. DeBakey Department of Surgery. “This is a very aggressive malignancy of the lining of the lungs. And it’s very hard to treat completely by surgical resection. In other words, there is often residual disease that is left behind. The treatment of this residual disease with local immunotherapy — the local delivery of relatively high doses of immunotherapy to that pleural space — is a very attractive way to treat this disease.”

Veiseh said the mesothelioma study began when Burt and Baylor surgeon and associate professor Dr. Ravi Ghanta heard about the early results of ovarian cancer animal tests Veiseh’s team was conducting with collaborators at the University of Texas MD Anderson Cancer Center. In March, Veiseh and MD Anderson collaborators published a study showing IL-2-producing beads could eradicate advanced-stage ovarian and colorectal tumors in mice in less than a week.

“They were really impressed by the preclinical data we had in ovarian cancer,” Veiseh said of Burt and Ghanta. “And they asked the question, ‘Could we actually leverage the same system for mesothelioma?’”

Source: https://blogs.bcm.edu/

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No More Glasses for Blurry Vision

Calendar August 29, 2022 | Posted by admin

New eye drops can limit the use for reading glasses. Vuity has just been approved by the Food and Drug Administration (FDA), and local ophthalmologists say it can be a life-changer. The drops are meant for people dealing with Presbyopia, an age-related eye issue that causes blurry vision. 

“We all know the reading glasses are annoying,” said Dr. Ella Faktorovich, an ophthalmologist with Pacific Vision Institute. “Within 15 minutes you can see your computer, you can see your phone so you can really improve the range of vision. I think it is huge.” She says the drops target the focusing mechanism in the eye. The drops shrink the pupils and increase focus on theeye.

“There are many kinds of this medicine in trials, but this is the first to be approved,” she said. “It is pretty remarkable.” It can help people like Lovester Law, who is currently writing a book. He says he spends hours looking at a screen to write. “After I read too much or write to long, I just have to close my eyes and relax,” he explained.

“If we live long enough our eyes are going to age, they are not going to be like they used to be.” People who want the drops will have to consult an eye doctor, because they are only available through a prescription. Doctors at UCSF say this breakthrough can be a catalyst for future eye treatment. “The data we have shows that it really really works,” stated Julie Schallhorn, Associate Professor of ophthalmology at UCSF. “It is an exciting time to be in this field, and an exciting time for our patients.“

The FDA approval of VUITY was based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of VUITY for the treatment of presbyopia.

Source: https://news.abbvie.com/

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The FDA Approved the First Online Vision Test

Calendar August 24, 2022 | Posted by admin

The Food and Drug Administration (FDA) on August 16 approved the first online visual acuity test made by the telehealth company Visibly. This clearance will allow adults ages 22 to 40 to evaluate their vision from the convenience of their homes. The FDA approval may increase access for people who are in need of a renewed prescription for glasses or contacts but cannot travel to an appointment. However, it’s not a replacement for an in-person eye exam.

“During the pandemic, a lot of people delayed elective health care that was really important,” said Yuna Rapoport, MD, MPH, a board-certified ophthalmologist at Manhattan Eye. “Overall, this remote vision test is helpful. If you really want an accurate prescription, and there’s a way to get to a doctor’s office, I would still say that that’s a better option.”

A visual acuity test is one of the most important components of an eye exam. It measures how well you can see by testing the smallest letters or images you can read clearly.

According to Visibly, the online visual test is best for “people whose vision has not changed, have recently completed a comprehensive eye exam,” and are looking to renew an expired prescription. The test is not a substitute for, nor does it provide screening or diagnosis for eye health or eye diseases, which should be performed by a licensed provider, according to the FDA.

Paul Foley, Visibly’s chief operating officer, said in a press release that the online vision test will increase at-home use and complement in-person eye care. The test takes about six minutes to complete and 90% of the prescriptions are issued within 24 hours, according to the company.

Source: https://www.govisibly.com/
AND
https://www.verywellhealth.com/

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Artificial Intelligence Finds New Drug Molecules a Thousand Times Faster

Calendar July 15, 2022 | Posted by admin

The entirety of the known universe is teeming with an infinite number of molecules. But what fraction of these molecules have potential drug-like traits that can be used to develop life-saving drug treatments? Millions? Billions? Trillions? The answer: novemdecillion, or 1060. This gargantuan number prolongs the drug development process for fast-spreading diseases like Covid-19 because it is far beyond what existing drug design models can compute. To put it into perspective, the Milky Way has about 100 billion, or 1011, stars.

In a paper that will be presented at the International Conference on Machine Learning (ICML), MIT researchers developed a geometric deep-learning model called EquiBind that is 1,200 times faster than one of the fastest existing computational molecular docking models, QuickVina2-W, in successfully binding drug-like molecules to proteins. EquiBind is based on its predecessor, EquiDock, which specializes in binding two proteins using a technique developed by the late Octavian-Eugen Ganea, a recent MIT Computer Science and Artificial Intelligence Laboratory and Abdul Latif Jameel Clinic for Machine Learning in Health (Jameel Clinic) postdoc, who also co-authored the EquiBind paper.

Before drug development can even take place, drug researchers must find promising drug-like molecules that can bind or “dock” properly onto certain protein targets in a process known as drug discovery. After successfully docking to the protein, the binding drug, also known as the ligand, can stop a protein from functioning. If this happens to an essential protein of a bacterium, it can kill the bacterium, conferring protection to the human body.

However, the process of drug discovery can be costly both financially and computationally, with billions of dollars poured into the process and over a decade of development and testing before final approval from the Food and Drug Administration. What’s more, 90 percent of all drugs fail once they are tested in humans due to having no effects or too many side effects. One of the ways drug companies recoup the costs of these failures is by raising the prices of the drugs that are successful.

The current computational process for finding promising drug candidate molecules goes like this: most state-of-the-art computational models rely upon heavy candidate sampling coupled with methods like scoring, ranking, and fine-tuning to get the best “fit” between the ligand and the protein.

EquiBind (cyan) predicts the ligand that could fit into a protein pocket (green). The true conformation is in pink.

Hannes Stärk, a first-year graduate student at the MIT Department of Electrical Engineering and Computer Science and lead author of the paper, likens typical ligand-to-protein binding methodologies to “trying to fit a key into a lock with a lot of keyholes. ” Typical models time-consumingly score each “fit” before choosing the best one. In contrast, EquiBind directly predicts the precise key location in a single step without prior knowledge of the protein’s target pocket, which is known as “blind docking.”

Unlike most models that require several attempts to find a favorable position for the ligand in the protein, EquiBind already has built-in geometric reasoning that helps the model learn the underlying physics of molecules and successfully generalize to make better predictions when encountering new, unseen data.

Source: https://news.mit.edu/

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