HumanOptics has received FDA approval for its ArtificialIris prosthesis. The ArtificialIris is used to treat patients who have partially or completely lost their iris as the result of an accident or who were born without an iris. This affliction is very burdensome to patients and often comes with a range of additional medical complications, such as light sensitivity, loss of vision, or an above-average risk of glaucoma and cataract formation.
“Our custom-made iris implant is a unique product with extremely high benefits to patients. That is why our ArtificialIris was accepted into the FDA’s Breakthrough Devices Program on December 1, 2017. Just a few months later, we have already received approval for it,” Dr. Pierre Billardon, CEO of HumanOptics, said in a company news release. “The ArtificialIris is at present the only product of this kind that is approved for the highly attractive U.S. market and addresses this currently unmet medical need in that market.”
Every ArtificialIris is customized by HumanOptics to match the original appearance of the patient’s iris. It is made of a flexible silicon material that is inserted into the eye using a microsurgical technique – making it well tolerated. This ensures both the patient’s clinical and aesthetic needs are met, achieving a high level of satisfaction.
As part of a medical study begun in 2013, more than 600 successful operations have already been performed at 12 hospitals throughout the country. The market potential for the product is about 150 hospitals and 1,000 to 1,500 patients per year, according to HumanOptics.
“We predict that the artificial iris will become a top product for our company over the medium term,” Dr. Billardon said. “Many of our current surgeons already have waiting lists of patients who need our artificial iris but were unable to be treated during the study. Besides the significant market potential in the US, FDA approval will also boost our image in the European markets, where we are already allowed to offer this product.”