Abbott Laboratories

USFDA approves first intraocular lens for cataract patients

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The U.S. Food and Drug Administration approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.

Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. According to the National Eye Institute, more than 20 percent of Americans will have cataracts by the age of 65, and the prevalence increases with age. In cataract surgery, the clouded natural lens is removed and replaced with an IOL.

“While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health. “The Tecnis Symfony Extended Range of Vision IOL provides a new option for patients that may result in better vision across a broader range of distances.”

Traditional monofocal IOLs have been limited to improving distance vision. The Tecnis Symfony IOL improves visual acuity at close, intermediate and far ranges and, therefore, may reduce the need for patients to wear contact lenses or glasses after cataract surgery.

The approval is based on a review of results from a randomized clinical trial comparing 148 cataract patients implanted with the Tecnis Symfony IOL to 151 cataract patients implanted with a monofocal IOL. The study evaluated visual acuity at near, intermediate and far ranges; contrast sensitivity (the ability to distinguish small differences between light and dark); and adverse events for six months after implantation. Of the patients implanted with the Tecnis Symfony IOL, 77 percent had good vision (20/25), without glasses at intermediate distances, compared to 34 percent of those with the monofocal IOL. For near distances, patients with the Tecnis Symfony IOL were able to read two additional, progressively smaller lines on a standard eye chart than those with the monofocal IOL. Both sets of patients had comparable results for good distance vision.

Patients implanted with the Tecnis Symfony IOL may experience worsening of or blurred vision, bleeding or infection. The device may cause reduced contrast sensitivity that becomes worse under poor visibility conditions such as dim light or fog. Some patients may experience visual halos, glare or starbursts. The device is not intended for use on patients who have had previous trauma to their eye.

The Tecnis Symfony IOL is also available in four toric models, which are indicated for the reduction of residual refractive astigmatism or imperfections in the curvature of the eye.

The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.

Source: 1, 2

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Audit of Indian Nutraceutical Companies – Next on USFDA Agenda

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US FDA may embark on an intensive audit of all Indian production plants engaged in the manufacture of dietary supplements covering health ingredients and nutraceuticals. The key objective is to ensure compliance of facilities adhering to its FDA 101: Dietary Supplements norms of 2008.

The drug regulatory authority will specifically look at 21 CFR Part 100 and 111 in the dietary supplements guidelines focusing on current Good Manufacturing Practice in production, packaging and labeling which are critical in marketing and recommending to the medical fraternity and consumers.

The dietary supplements include vitamins, minerals, amino acids, botanicals, as well as other substances that can be used to supplement the diet. Some ingredients and products can be harmful when consumed in high amounts and taken for a long time, or when used in combination with certain other drugs, substances, or foods. The supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. It is also suggested by the regulatory authority that health care professionals should be consulted before using any dietary supplement.

At least five companies of Bengaluru are identified for audit by the drug regulatory authority. With the increasing healthcare costs, fast changing lifestyle, ageing population and rising interest in attaining wellness through diet, nutraceuticals has emerged as one of the fastest growing industry segments in the country according to an official.

Early this year, Drugs Control General of India (DCGI) was looking to appoint an expert committee to look into the nutraceutical manufacture and regulatory norms to ensure industry complies with the highest quality standards. The industry has also asked DCGI for more clarity on the same.

Almost every pharma company has a dedicated nutraceutical and dietary supplement portfolio. Current market size for nutraceuticals and health ingredients is pegged at around Rs.4,500 crore in India registering an annual growth rate of 25 per cent.

Leading players are British Biologicals GSK, Piramal, Abbott, Sun Pharma Herbalife, British Biologicals, Amway, Nestle Nutrition, Sami Labs, Biogen Phytotec Extracts, Green Chem, Parrys and DSM Nutrition.

There is a huge awareness for wellness driving the growth of this sector. Therefore the USFDA is closely monitoring the contents on the label and comparing it with the actual contents in the nutraceutical bottle or tin or packet.

The industry expert also pointed out that in the interest of the consumer health and well being for prevention of diseases and a patient’s rejuvenation phase, India too needs a dedicated set of guidelines for dietary supplements. There are several herbal formulations in the market which need scrutiny. So far it has been difficult for the regulator to classify products as nutraceuticals or as a drug going by the contradictory claims made by the companies through the labels and advertisements.

Source: 1

AbbVie begins phase III study of Veliparib in patients with advanced breast cancer

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AbbVie announced the initiation of a Phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888), when added to carboplatin and paclitaxel, two chemotherapeutic medicines, in patients with advanced breast cancer. Specifically, the combination of veliparib, carboplatin and paclitaxel will be compared to treatment with carboplatin, paclitaxel and placebo in patients with human epidermal growth factor receptor 2-(HER2) negative metastatic or locally-advanced breast cancer, containing BRCA1 and/or BRCA2 gene mutations.

“Our Phase III programme for veliparib represents an innovative approach to developing this type of anti-cancer compound. By adding veliparib to DNA-damaging therapies, such as carboplatin and paclitaxel, we can evaluate its potential to provide incremental benefit to existing treatments,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This is the third Phase III trial evaluating the efficacy and safety of veliparib, and the second evaluating the addition of veliparib to chemotherapy for the treatment of patients with difficult-to-treat forms of breast cancer.”

The randomised, double-blind, Phase III clinical trial will recruit approximately 270 patients. The primary efficacy outcome of the trial is progression-free survival (PFS). The secondary pre-specified outcome measures include overall survival (OS), clinical benefit rate (CBR), objective response rate (ORR) and duration of response (DOR).

Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerases (PARP) inhibitor being evaluated in multiple tumour types. PARP is a naturally-occurring enzyme in the body that repairs damage to DNA, and in certain types of cancers, repairs cancer cells. Discovered and developed by AbbVie researchers, veliparib is being developed to help prevent DNA repair in cancer cells and increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in more than a dozen cancers and tumour types, including Phase III studies in non-small cell lung cancer and breast cancer.

Breast cancer is the second most common cancer in the world and the most commonly diagnosed cancer in women worldwide.1 The HER2 gene, which normally helps cells in the breast remain healthy and function normally, can play a role in the development of breast cancer. Specifically, in approximately 25 per cent of breast cancers, the HER2 gene does not work properly, causing cells in the breast to grow and divide in an uncontrolled way. This process, known as HER2 gene amplification or over expression, results in HER2-positive breast cancer. HER2-positive breast cancers tend to grow faster, metastasize more quickly and are more likely to recur, compared to patients diagnosed with HER2-negative breast cancer.

It is estimated that at least five percent of breast cancer cases result from inherited mutations or alterations in the BRCA1 and BRCA2 breast cancer susceptibility genes. Women with these mutations have a 40- to 85-per cent lifetime risk of developing breast cancer. Additionally, men with BRCA2 mutations carry an increased risk of breast cancer.

  Source: PharmaBiz