Staar Surgical's ICL
This article was originally published in The Gray Sheet
Executive SummaryStart of Phase II trials of the implantable contact lens for hyperopia (farsightedness) is announced by the company March 25. FDA's approval allows the company to expand its investigator base from four to 10 surgeons and to implant 62 ICLs in patients. A Phase I hyperopia trial conducted outside the U.S. included 10 patients with an average preoperative hyperopia of 6.05 diopters. Results showed seven of the ten patients with 20/20 vision or better without glasses or contact lenses and all 10 had 20/40 or better following the procedure, the company claims. Placed in the eye during a suture-less outpatient procedure, the ICL is currently in Phase II trials for myopia. The company hopes to commence Phase III of that trial in the near future. The company received CE mark approval for the ICL in July
You may also be interested in...
China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.
A regulatory framework that encourages physicians to conduct experimental cell and gene therapies have propelled China to become a major developer of such promising cancer-treating tools, but insiders say three are a plethora issues at stake.