The company has tabbed the lens, marketed as Artiplus, as a first-in-class solution for young presbyopes.
A new phakic solution for tackling presbyopia in younger patients has come to Europe with the European Commission’s granting of CE Mark approval to Ophtec’s (Groningen, Netherlands) Artiplus Phakic IOL on Monday, 19 November 2024.
The company has said that the Artiplus Phakic IOL is designed for presbyopes in their early 40s seeking clear vision at all distances without needing reading glasses or other corrective eyewear. The lens is built on Ophtec’s Artiflex platform and features multi-segmented optic (CTF technology), which the company purports to provide multiple focal points for continuous vision at varying distances.
Opthtec believes the Artiplus Phakic IOL fills a critical hole in the current presbyopia treatment landscape.
“We are thrilled to introduce Artiplus as a new treatment option for presbyopia,” said Opthtec Global Product Manager Tiago Guerreiro in a news release. “Many people in their 40s are frustrated with the limitations of reading glasses or are struggling with multifocal glasses.
“Traditional presbyopia treatments, like laser surgery, are not sufficient for many patients. Artiplus offers a compelling solution for those seeking to regain a high quality of vision at all distances.”
The approval comes after the company released data from its one-year, 9-country clinical trial at the 42nd Congress of the European Society of Cataract and Refractive Surgeons in Barcelona in September. According to Prof. Dr. José Luis Güell (Spain), lead investigator in the Artiplus clinical trial, these results and his experiences have been positive.
“The one-year follow-up data for uncorrected distance, intermediate and near visual acuity were extraordinarily good. In my experience with Artiplus, the results have been extremely consistent,” he said.
Artiplus is already available in South Korea, where doctors like early adopter Dr. Chin Young Im have echoed these experiences in a clinical setting.
“I have successfully implanted Artiplus in pseudophakic patients, and they are all very pleased with the outcomes,” Dr. Chin said.
With this CE Mark approval, Ophtec hopes to join the rapidly expanding adoption of phakic IOLs in refractive practices around the world, including the runaway success of technologies like the STAAR (Monrovia, California, United States) EVO ICL for myopia and astigmatism.
After this CE Mark approval, Ophtec plans to continue to expand the availability of Artiplus to presbyopia patients worldwide.
