Staar Surgical
This article was originally published in The Gray Sheet
Executive Summary
Phase III clinical trials for its intraocular Implantable Contact Lens for the treatment of myopia will begin following FDA go ahead. Staar, which so far has tested the ICL in 80 eyes, may now implant another 278 IOLs, while increasing the number of sites to 15, the company says. The Monrovia, California-based firm also may expand its study to treat patients with as little as -3 diopters of refractive error and reduce the waiting period for patients to receive an IOL in the second eye to 45 days from six months
You may also be interested in...
Investors Go Beserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.