SERI Lugano: ParaCel Riboflavin Selected by FDA for Epi-on Cross-Linking for Keratoconus

The Switzerland Eye Research Institute has announced that the breakthrough transepithelial riboflavin formulation known as ParaCel, and based on the research of its CEO and Founder Roberto Pinelli, MD, has been selected among many others by the FDA for an epithelium-on corneal collagen cross-linking protocol for patients with progressive keratoconus, according to a company news release.

All of the intellectual property rights to produce, market and distribute ParaCel have been acquired by Avedro in 2011. Avedro reached the agreement with FDA in order for many patients and practices in the US to offer a new procedure designed to eliminate the need to remove the epithelium, explained Avedro’s chief medical officer Rajesh K. Rajpal, MD.

“ParaCel has been formulated to softly penetrate the corneal epithelium without the need to remove it. The higher concentration of riboflavin and proprietary formulation allow for the fastest penetration and diffusion into the corneal stroma. The osmotic property of this distinctive riboflavin solution is the key to the efficacy and safety of this treatment. I am happy to know that the molecule I conceived and then released to Avedro was chosen by such an outstanding institution as the FDA”, said Dr. Roberto Pinelli.