FDA | Ophthalmology Innovation Source

First Lucentis Biosimilar Launches in India, but Path in US not so Clear

The first biosimilar agent for Lucentis (ranibizumab, Genentech) has come to market in India with the launch of Intas Pharmaceuticals’’ Razumab in June. But whether biosimilar agents gain any traction in the United States remains to be seen as they must overcome myriad regulatory and competitive hurdles. Biosimilars are to branded biologic agents like Lucentis…

Calhoun Vision Stages Turnaround

Medtech companies in ophthalmology have made some significant strides in recent months. Second Sight and Glaukos, of course, staged IPOs in their pursuit of revolutionary ophthalmic devices. Oculeve excited Dry Eye leader Allergan enough to warrant a significant acquisition offer, bringing the highly promising neurostim device in-house where it may someday complement Restasis. Now we’re…

Were Glaukos’ IPO Investors Irrationally or Rightly Exuberant?

OIS Hot Shot Glaukos Corp. (NASDAQ—GKOS) raised over $100 million in an initial public offering (IPO) that highlighted extraordinary demand for ophthalmology’s minimally invasive glaucoma surgery (MIGS) market leader. In its initial SEC filing, Glaukos had proposed selling 5.4 million shares in the range $13 to $15 per share. With a positive investor reaction during…

Legislation Would Restore NEI/NIH Funding

The 21st Century Cures Act – which is receiving uncharacteristic bipartisan support – could restore many of the Ophthalmology-oriented research grant programs cut in recent years. By a 51-0 vote in May, the House Energy and Commerce Committee endorsed the increase of overall National Institutes of Health funding by $1.5 billion a year over each…

Investors Move Fast on AERI, AAVL Clinical News

Two presenters at the OIS saw their stock prices shoot in different directions following the release of news related to late-stage clinical trials. On Tuesday, Aerie Pharmaceuticals, received approval from the Food and Drug Administration to change the primary endpoint of its second Phase 3 trial of Rhopressa, its rho kinase (ROCK) inhibitor for reduction…

Aerie Pharmaceuticals

Rhopressa is a Rho-kinase and norepinephrine transporter inhibitor and lowers episcleral venous pressure, with phase 3 efficacy data expected mid-Q2 2015, and an FDA filing in mid-2016. The Rhopressa “Rocket 1” registration trial is designed to evaluate non-inferiority to timolol BID. Entry criteria included pressures in the 20-27 mmHg range. (A phase 2b study comparing…

Spotlight on Presbyopia

Participants: Gilbert H. Kliman, MD Dr. Gil Kliman leads the medical device investment team at InterWest Partners and invests in a broad array of healthcare opportunities, with a special interest in ophthalmology and digital health. View Full Profile Malvina B. Eydelman, MD Dr. Eydelman has been involved in all aspects of assuring the safety and…

2015 Review of the Ophthalmology Innovation Cycle

Moderator: William J. Link, PhD Bill was Founder, Chairman and CEO of Chiron Vision, sold in 1997. Bill founded and served as President of American Medical Optics (AMO), sold in 1986. View Full Profile Panelists: Richard Lindstrom, MD Dr Richard L Lindstrom, Founder and attending surgeon at Minnesota Eye Consultants, Adjunct Clinical Professor Emeritus at…

Avedro

An ophthalmic panel voted to approve Avedro’s collagen crosslinking device for keratoconus and ectasia, but the FDA did not approve the device. The Complete Response Letter involved only the device, and not the clinical aspects of the trial, and Avedro executives remain confident these last hurdles will be easily overcome. The company is also working…

PowerVision

PowerVision’s FluidVision is a shape-changing accommodating IOL that has been implanted in more than 100 patients to date. As patients focus on near objects, one drop of the lens’ fluid moves from the periphery to the center of the lens, changing its shape. When the patient focuses on a distance object, the reverse occurs. PowerVision…

Transcend Medical Ready To Make Move In MIGs

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 042″] Transcend Medical CMO Sean Ianchulev provides an update on COMPASS trial and shares company’s plan for the FDA. Podcast Guest Sean Ianchulev, MD, MPH Dr. Ianchulev is a physician-executive, innovator and venture capital investor with deep life-science and medical technology expertise. As an innovator he has been at the core…

Avedro CEO Muller Answers Questions About The FDA’s Questions

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 039″] David Muller, CEO of Avedro, addresses delays in the FDA’s review of the company’s riboflavin ophthalmic solution/KXL System for corneal cross-linking and discusses the considerable potential of PIXL. Podcast Guest David Muller, PhD Dr. Muller recognized the potential of using advanced methods to gently reshape the cornea and in 2007…