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Epi-LASIK device approved in Australia
Norwood EyeCare achieved approval for its epi-LASIK device in Australia. It also announced the appointment of a distributor there.
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Norwood EyeCare has been granted marketing approval for its epi-LASIK device in Australia, the company announced.
The device will be marketed in Australia and New Zealand by Bausch & Lomb (Australia) Pty. Ltd., according to Norwood.
Norwood EyeCare, a subsidiary of Norwood Abbey, recently received approval for the device from Australia’s Therapeutic Goods Administration, and subsequently it was used successfully on the first post-approval Australian patients.
Norwood acquired the technology for epi-LASIK, originally conceived by Ioannis Pallikaris, MD, PhD, from CIBA Vision in 2004. The device was granted marketing approval in the United States under its previous owner in 2003.
The Australian approval was announced at a press briefing led by Brisbane ophthalmologist Peter Stewart, MD, who brought one of his epi-LASIK patients to display the quality of vision and surgical outcome of epi-LASIK.
Dr. Stewart performed the patient’s treatment as part of an Australian clinical study under the Therapeutic Goods Administration.
He said the surface procedure’s results compare well with his considerably larger experience with LASIK.
“I have performed more than 15,000 laser vision correction procedures over 10 years using current technology, and there is no doubt epi-LASIK achieves better visual results for the patient, without the associated complications, risk or discomfort [of LASIK],” he said at the press briefing.
Australian potential
In a telephone interview, Bernie Romanin, Norwood’s vice president of corporate development, said “We are really rolling out this program now here in Australia.”
Australia is home to 30 refractive surgery centers with an annual volume of 30,000 procedures, a number that grows by about 15% per year, according to Mr. Romanin. He said this growth gives Norwood reason to be enthusiastic about the future of epi-LASIK in Australian ophthalmology.
“If you look at the population of Australia, specifically the population in the 18- to 44-year-old range, there are about 7.8 million people, and from that, the potential vision correction market is almost 2 million patients,” he said. “The penetration of LASIK is still low at less than 2%. Given that relatively low market penetration, it is a very exciting market, and creates an enormous amount of opportunities in this region for us.”
The company’s stock is already rising, according to Mr. Romanin. Norwood Abbey is publicly listed in Australia.
“I’d say that within the few weeks that the approval and the trials have started, our share prices appreciated up to 20%, which was above the market averages,” he told Ocular Surgery News.
Global position
CIBA Vision shepherded the epi-LASIK device, which was called the Centurion SES at the time, through the development and regulatory process until the end of 2003, when the technology got Food and Drug Administration approval and the European CE mark.
Norwood purchased the epi-LASIK platform in May 2004 after CIBA Vision broke its surgical business unit into smaller components. IOLTech, a French company, acquired CIBA’s IOL technologies, and Norwood acquired the epi-LASIK technology.
“CIBA Vision prioritized all the countries around the world, and Australia, because of its size, was not up in the top few. Obviously for us, being an Australian company as well, it was a high priority so we placed more emphasis on getting an approval here,” Mr. Romanin explained.
“It happened that a lot of our expertise in lasers emanated from the ophthalmic market, and hence we were able to very quickly bring this technology in because there was close to 50 years of expertise in lasers in ophthalmology in the company, and so we were able to integrate it very quickly,” he said.
The path ahead
Although three other companies have devices used for epi-LASIK, Norwood has exclusively licensed the worldwide rights to the epi-LASIK technology from the inventor of the technology, Prof. Pallikaris.
“There is quite an extensive intellectual property portfolio under development, which is clearly a strong component of the product, and that’s held by Norwood Abbey,” Mr. Romanin said.
According to Mr. Romanin, Norwood has an ongoing research agreement with the University of Crete and Dr. Pallikaris that will be looking into other ways of enhancing the epi-LASIK technology.
For Your Information:
- Bernie Romanin can be reached at Norwood Abbey Ltd., 63 Wells Road, Chelsea Heights 3196, Australia; 61-39782-7333; fax: 61-39782-7334; e-mail: bromanin@norwoodabbey.com.au.
- The global network of distributors for Norwood EyeCare’s Epi-LASIK technology can be viewed on the company’s Web site: www.norwoodeyecare.com.
- Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.