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Ciba vision seeks drugs controller nod to launch visudyne therapy 

Anju Ghangurde  
Mumbai, June 19 : Ciba Vision, the eye care unit of Novartis, has made an application to the Drugs Controller General of India (DCI) to seek approval for introducing Visudyne therapy, a breakthrough technology for treating the wet form of Age-related Macular Degeneration (AMD). AMD is one of the leading causes of blindness in people over 50 years of age.

Novartis India vice president PP Krishnamurthy said that the company was awaiting the DCI's instructions on conducting tests in India. Visudyne has been approved by the US Food and Drugs Administration (USFDA) and is commercially available in Switzerland and Malta. As on April 13, 2000, regulatory applications were pending in the European Union, Canada, Australia and Brazil, among others.

Visudyne is injected intravenously into the patient's arm and accumulates in higher concentrations in damaged vessels in the eye. The drug is then activated by shining non-thermal laser light into the patient's eye for approximately 83 seconds. Once activiated, Visudynecauses a closure of the leaking blood cells and a corresponding stablisation of vision. Wet AMD is characterised by the formation of abnormal blood vessels. These vessels leak fluid and lead to the formation of scar tissue on the macula, which is the small area of the eye located in the centre of the retina. Wet AMD develops rapidly and a majority of patients may go blind within three years of being diagnosed.

Krishnamurthy said, "This new therapy will help slow down the inevitable progression towards the loss of central vision. Our aim is to spread awareness about AMD, the need for early detection and the various treatment options available worldwide". Medical experts estimate that approximately five lakh cases of wet AMD are diagnosed globally each year. Visudyne is being co-developed for ocular conditions by Ciba Vision Corporation and QLT PhotoTherapeutics Inc. The former markets the product while QLT retains the responsibility for manufacturing the product.

Ciba Vision's domestic product basketincludes brands like Voveran Ophtha, Okacin, Clearine, Nyolol and Hypotears Plus. Nyolol which was launched this month, marks Ciba's entry into the anti-glaucoma segment.

Wesley Jessen deal to boost Ciba portfolio
Ciba Vision's global acquisition of Wesley Jessen VisionCare Inc is expected to strengthen the acquirer's Indian product portfolio. Wesley Jenssen VisionCare is the leading developer, manufacturer and marketer of specialty contact lenses worldwide.

Indications are that Wesley Jenssen Visioncare brands like Freshlooks and Durasoft are already present in the Indian market and these are expected to complement Ciba Vision's existing range. Ciba Vision is also likely to introduce one-day contact lenses -Focus Dailies -this year. Focus Dailies come with a thinner edge designed to provide relief from the common complaint of "edge sensation", an irritation experienced when the eyelid rubs against edges of the contact lense.

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