FDA | Ophthalmology Innovation Source

Aerie Pharmaceuticals With Two ROCK Inhibitors In Development

Publicly traded Aerie Pharmaceuticals Inc. has two Rho kinase inhibitors, or ROCK inhibitors, in development, CEO Vicente Anido, Jr, PhD, reported Rhopressa which is in phase III studies, and Roclatan, a Rhopressa-latanoprost combination that is entering a Phase III trail. ROCK inhibitors have been known to improve aqueous outflow through the trabecular meshwork and, possibly, improve…

Avedro Broadens Cross-Link Product Line

Corneal collagen cross-linking has been a vexing specialty for US-based companies trying to guide a product through a cautious FDA. But Massachusetts-based Avedro Inc., continues to establish a meaningful portfolio in the space through deals like the acquisition of Switzerland-based IROC Innocross AG. Avedro acquired the assets of IROC Innocross, which was the first company…

Mazzo Muses On The FDA, Google & Failing Fast

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 001″] Jim Mazzo, Chairman and CEO of AcuFocus, offers his insights on why ophthalmology remains a standout sector in life sciences and what investors and entrepreneurs need to do to find success in Medtech. Also, what should we make of Google’s contact lens deal with Novartis? Podcast Guest Jim Mazzo Jim…

PowerVision

Barry Cheskin discusses PowerVision’s six month data on their pilot study and the beginning their CE mark study. Presenter: Barry Cheskin Barry Cheskin is Co-Founder, President & CEO of PowerVision. Mr. Cheskin has over 20 years of general management experience in the medical device business. View Full Profile

The Role of OUS Clinical Studies

Malvina B. Eydelman, MD give her presentation on some of the newest directions coming out of the FDA for device studies in the US followed by a panel discussion on clinical studies in the US vs. clinical studies overseas. Moderator: Gilbert H. Kliman, MD Dr. Gil Kliman leads the medical device investment team at InterWest…

Avedro

Presenter: David Muller, PhD Dr. Muller recognized the potential of using advanced methods to gently reshape the cornea and in 2007 founded Avedro, Inc., where he serves as the CEO. View Full Profile

RPS

Presenter: Robert P. Sambursky, MD Robert Sambursky, MD is CEO, and President of RPS Diagnostics (RPS®), an innovative biotechnology company with a proprietary point-of-care diagnostic testing platform to rapidly and accurately diagnose a variety of infectious diseases and inflammatory conditions. View Full Profile

TearLab

Presenter: Elias Vamvakas Mr Vamvakas is the Chairman and CEO of TearLab Corporation. Prior to TearLab, Mr. Vamvakas co-founded TLCVision (NASDAQ/TLCV, TSX/TLC) in 1993 where he served as President and CEO until 2003. View Full Profile

Neovista – A Challenging Journey

Versant Ventures Managing Director William J. Link PhD talks about the journey of NeoVista through all of its ups and downs. Ultimately Neovista was able to get its CE Mark, but failed to get approved by the FDA due to a spiral of “stacking” risks. Presenter: William J. Link, PhD Bill was Founder, Chairman and…

“The Long and Winding Road”

The March 14th meeting of the FDA’s Ophthalmic Devices Panel Advisory Committee, which was convened by the FDA to consider the pre-market application (PMA) for STAAR Survival’s toric implantable collamer lens (TICL) brought to my mind the Beatles song “The Long and Winding Road” from their 1970 album “Let it Be.” The reason? It has…

Innovation, Industry and Consultants – Good for Patients

Polio crippled President Franklin D. Roosevelt, and it infected and often paralyzed thousands of other Americans—58,000 in 1952 alone. Many historians consider the eradication of polio in the United States the greatest medical breakthrough of the 20th century. As recently as 1988, polio infected 350,000 individuals worldwide. In 2001, the World Health Organization documented only…

Developing an Effective Dialogue with the FDA

Moderating an informative conversation surrounding FDA procedures and communication, Emmett Cunningham, Summit Chairman, draws detailed responses from Wiley Chambers and Malvina Eydelman of the FDA. Focusing the discussion around common questions on how best to interact with the FDA, both formally and informally, Emmett helps deliver the specific answers attendees at the 5th Annual Ophthalmology…