Category Archives: Ophthalmology

Takeda could sell Shire eye care business after merger

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Takeda could be considering selling Shire’s eye care business after their $62 billion merger next year to cut debts, according to press reports.

Citing sources close to the matter Bloomberg said the Shire’s Xiidra eye drug is among the potential divestments being assessed by Takeda.

Another possible sell-off could be Shire’s Natpara medicine, used to control low blood calcium related to parathyroid hormone, according to Bloomberg’s anonymous sources.

Takeda could raise between $4 billion and $5 billion depending on the assets that get sold, according to the sources.

Discussions are at an early stage and Takeda has not made a firm decision about what to sell off, according to Bloomberg.

There has also been interest in Takeda’s OTC business, according to the report, but Takeda’s CEO Christophe Weber told Japan’s Nikkan Kogyo newspaper in July that the company does not intend to sell its OTC operations in the island nation.

The rationale behind the merger is to reshape Takeda so that it has a suite of rare disease drugs, which Shire has assembled through its own acquisition spree over the last few years.

Takeda already has a $31 billion loan facility in place to help pay for the acquisition, the largest borrowing ever by a Japanese company for an acquisition.

Bloomberg said that neither Shire or Takeda’s representatives were prepared to comment.

The deal is set to close in the first half of 2019 if approved by shareholders, if it obtains regulatory approvals in more than 20 markets and if approved at an extraordinary general meeting of shareholders.

Competition regulators in the US and Brazil have already backed the deal, and Takeda has asked for clearance in China, Canada and Mexico.

Markets where Takeda still needs clearance include Japan and the EU – and Bloomberg noted that the merger could face tougher scrutiny in the EU where reviews assess how pharma companies compete in each of its 28 nations.

Another possible spanner in the works could come from the influential family that originally founded Takeda, who are fighting the deal along with a group of other shareholders.

Last week, Kazu Takeda, from the family group, reportedly said the takeover could be “disastrous” and risked undoing the company’s corporate philosophy called “Takeda-ism” – this states that profit comes from making people happy.


AI Can Deliver Specialty-Level Diagnosis In Primary Care Setting

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A system designed by a University of Iowa ophthalmologist that uses artificial intelligence (AI) to detect diabetic retinopathy without a person interpreting the results earned Food and Drug Administration (FDA) authorization in April, following a clinical trial in primary care offices.

Results of that study were published Aug. 28 online in Nature Digital Medicine, offering the first look at data that led to FDA clearance for IDx-DR, the first medical device that uses AI for the autonomous detection of diabetic retinopathy.

The clinical trial, which also was the first study to prospectively assess the safety of an autonomous AI system in patient care, compared the performance of IDx-DR to the gold standard diagnostic for diabetic retinopathy, which is the leading cause of vision loss in adults and one of the most severe complications for the 30.3 million Americans living with diabetes.

IDx-DR exceeded all pre-specified superiority endpoints in sensitivity, the ability to correctly identify a patient with disease; specificity, the ability to correctly classify a person as disease-free; and imageability, or the capability to produce quality images of the retina and determine the severity of the disease.

“The AI system’s primary role is to identify those people with diabetes who are likely to have diabetic retinopathy that requires further evaluation by an eye-care provider. The study results demonstrate the safety of autonomous AI systems to bring specialty-level diagnostics to a primary care setting, with the potential to increase access and lower cost,” says Michael Abràmoff, MD, PhD, the Robert C. Watzke Professor of Ophthalmology and Visual Sciences with UI Health Care and principal investigator on the study. He is founder and president of IDx, the company that created the IDx-DR system and funded the study.

Early detection may prevent vision loss

More than 24,000 people in the U.S. lose their sight to diabetic retinopathy each year. Early detection and treatment can reduce the risk of blindness by 95 percent, but less than 50 percent of patients with diabetes schedule regular exams with an eye-care specialist.

In the study, 900 adult patients with diabetes–but no history of diabetic retinopathy–were examined at 10 primary care sites across the U.S. Retinal images of the patients were obtained using a robotic camera, with an AI assisting the operator in getting good quality images. Once the four images were complete, the diagnostic AI then made a clinical diagnosis in 20 seconds. The diagnostic AI detects disease just as expert clinicians do, by having detectors for the lesions characteristic for diabetic retinopathy, including microaneurysms, hemorrhages, and lipoprotein exudates.

Camera operators in the study were existing staff of the primary care clinics, but not physicians or trained photographers.

“This was much more than just a study testing an algorithm on an image. We wanted to test it in the places where it will be used, by the people who will use it, and we compared it to the highest standard in the world,” says Abràmoff, who also holds faculty appointments in the UI College of Engineering.

AI measured against gold standard

Study participants also had retinal images taken at each of the primary care clinics using specialized widefield and 3D imaging equipment without AI operated by experienced retinal photographers certified by the Wisconsin Fundus Photograph Reading Center (FPRC)–the gold standard in grading the severity of diabetic retinopathy.

Complete diagnostic data accomplished by both the AI system and FPRC readers was available for 819 of the original 900 study participants. FPRC readers identified 198 participants with more than mild diabetic retinopathy who should be further examined by a specialist; the AI was able to correctly identify 173 of the 198 participants with disease, resulting in a sensitivity of 87 percent. Among the 621 disease-free participants identified by FPRC readers, AI identified 556 participants, for a specificity of 90 percent. The AI had a 96 percent imageability rate: of the 852 participants who had an FPRC diagnosis, 819 had an AI system diagnostic output.

In June, following FDA clearance, providers at the Diabetes and Endocrinology Center at UI Health Care-Iowa River Landing in Coralville, Iowa, were the first in the nation to begin using IDx-DR to screen patients.

“We are hoping to do this also for early detection of diseases like glaucoma and macular degeneration. We are working on those algorithms already. The goal is to get these specialty diagnostics into primary care and retail, which is where the patients are,” Abràmoff says.

IDx is working with the American Medical Association to ensure that there is clear coding guidance for billing of IDx-DR. Providers, physicians, and suppliers should contact their third-party payers for specific and current information on their coding, coverage, and payment policies. IDx is a licensed distributor of the robotic camera used in the study.


Final NHS nod for Roche’s RoActemra

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Roche/Chugai’s RoActemra should be routinely offered throughout the NHS to adults with giant cell arteritis (GCA) within the next three months, following a final green light from cost regulators.

Almost 15,000 patients develop GCA in the UK every year. The condition is a potentially life-threatening form of vasculitis that results in inflammation of blood vessels, which can be difficult to diagnose because of its wide range of symptoms, including severe headaches, scalp tenderness and jaw pain. If left untreated it can lead to blindness, aortic aneurysm or stroke.

To date, management of GCA has been limited to long-term high-dose steroids, but this can cause skin problems and weight gain, as well as diabetes and osteoporosis in the long-term. There have been no treatment advances for GCA for nearly 60 years.

RoActemra (tocilizumab) is an anti-IL-6 receptor licensed for the treatment of adult patients with moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children two years of age and older, and for the treatment of GCA in adults.

Clinical trial results show that after having RoActemra plus a tapering course of glucocorticoids for one year, more people stay in remission and need lower doses of glucocorticoids compared with people having glucocorticoids alone.

The National Institute for Health and Care Excellence is recommending funding for one year’s treatment with the drug for patients who suffer flares of their GCA or may not respond fully to steroids, as their disease is most difficult to control.


AI predicts heart attack risk factors from retinal scans

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Artificial Intelligence can be used to predict heart attack risk using retinal images, according to new research backed by Google.

The researchers trained deep learning algorithms on data from thousands of patients recorded in a massive UK study, which was used with retinal scans to produce a program that can identify risk factors from the scan information alone.

This predicted cardiovascular risk factors not previously thought to be quantifiable using retinal images: these included age, gender, smoking status, gender, systolic blood pressure and major adverse cardiac events.

Reporting results in the journal Nature Biomedical Engineering, the team used a dataset from the UK’s Biobank, a study where 500,000 were recruited between 2006 and 2010, and agreed to have certain health measurements recorded.

Health outcomes such as hospitalisation, mortality and cause of death were also logged. Smoking status was obtained via survey using a touchscreen interface in the research backed by Google and Verily, Alphabet’s healthcare subsidiary.

Participants were also asked to identify whether they are a current smoker, former smoker, or had never smoked, and blood pressure readings were also taken.

A further 67,725 had paired images of their retina fundus taken, along with a second group that was used to create a training dataset with known risk factors.

The researchers asked a neural network to make an output prediction based on the fundus image.

It was able to analyse images from the group with unknown risk factors, compare it with the training data set and after the process was repeated, was eventually able to predict cardiovascular risk factors from new images.

This is just the latest in a series of studies showing the potential of AI to predict healthcare outcomes, saving lives and reducing costs by ensuring patients receive timely and sometimes life-saving treatments.

Early last month, the government’s life sciences tsar, Sir John Bell, said that similar techniques could save the NHS billions.

A team at Oxford’s John Radcliffe Hospital is using AI to identify abnormalities in ECG read-outs that could be missed by the human eye, for instance.

The hope is that this system could be used in hospitals across the country to prevent unnecessary hospitalisations caused by false positives, and prevent heart attacks where at-risk patients are sent home because doctors have failed to spot problems.

Another AI system outperformed a panel of experts when asked to diagnose breast cancer based on stained tissue samples, in a separate study published in the Journal of the American Medical Association last month.


Federal court quashes Allergan eye drop patents

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Ruling negates company’s deal with Mohawk tribe to avoid patent board review

A US federal court has ruled that four patents relating to Allergan’s Restasis (ciclosporin) eye drops are invalid. The ruling opens the way for challengers Mylan and Teva to introduce generic versions. Allergan has said it will appeal the decision.

The ruling renders Allergan’s transfer of these patents to the St Regis Mohawk tribe null and void – Allergan intended the deal to shield the company from a parallel challenge through the US Patent and Trade Office, by employing the Native American tribe’s sovereign immunity from such challenges.

At the same time, Allergan had struck a deal with Pfizer subsidiary Innopharma to resolve litigation over the same patents. Allergan has granted Innopharma a license to market a generic cyclosporin eye treatment in the US in February 2024 – about six months before its patents were due to expire – or earlier under certain circumstances. It is unclear how the court’s ruling would affect this deal.

Allergan noted in a statement that neither Mylan nor Teva has yet received regulatory approval for their generic cyclosporine eye drops. However, both companies already produce the drug in capsule form, and the ruling clears the way for them to be launched as soon as they are approved.


Shire sues Allergan in U.S. over dry eye drug

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(Reuters) – Allergan Plc was sued on Monday by Shire Plc for allegedly scheming to block doctors from prescribing its new treatment for dry eye disease.

In a complaint filed with the federal court in Newark, New Jersey, Shire accused Allergan of violating antitrust laws to preserve its roughly 90 percent share in Medicare prescription drug plans for its older and “clinically inferior” dry eye drug Restasis, and block prescriptions of Shire’s rival drug Xiidra.

“Quite simply, Allergan has and will continue to use bundled discounts, exclusive dealing, coercion and interference to unlawfully ‘block’ Shire from competing with it, and to maintain its monopoly in the Part D market at all costs,” Shire said, referring to the Medicare drug plans.

The lawsuit follows Allergan’s announcement on Sept. 8 that it transferred its Restasis patents to the Saint Regis Mohawk Tribe in upstate New York, whose sovereign status could limit legal challenges. The Tribe subsequently agreed to license the patents to Allergan.

Four U.S. senators last week called for a probe of whether the unusual move was anti-competitive and intended to keep prices high.

Restasis is Allergan’s largest drug other than Botox, with sales of $1.49 billion in 2016 and $676.4 million in the first six months of 2017, regulatory filings show. Shire has said Xiidra sales totaled $96 million from January to June.

Allergan spokesman Mark Marmur said the lawsuit has no merit, and the company complies with Medicare procedures.

“Competition in the chronic dry eye therapeutic market has driven pricing down for patients and payers in Medicare Part D and commercial plans,” he said in an email. “Restasis continues to provide significant value to Medicare beneficiaries, providers and the Part D program.”

Dry eye occurs when the eye produces tears improperly or with the wrong consistency. Failing to treat it can lead to inflammation, scarring and even vision loss. The condition is often chronic, and affects nearly 16 million U.S. adults.

Allergan and Shire are headquartered in Dublin, Ireland, although Allergan has operations in Parsippany, New Jersey, and Shire in Lexington, Massachusetts.

Shire won U.S. Food and Drug Administration approval in July 2016 for Xiidra, the first dry eye disease drug to win FDA approval since Restasis in 2002.

The chemical name for Restasis is cyclosporine, and for Xiidra it is lifitegrast.

The case is Shire US Inc v Allergan Inc et al, U.S. District Court, District of New Jersey, No. 17-07716.