A favorite From The OIS Podcast Stack

OIS Podcast

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 049″] Oculeve’s stunning acquisition by Allergan last week led us back to a conversation we had with Mark S. Blumenkranz, MD, Professor & Chairman of the Department of Ophthalmology, Stanford University. Mark S. Blumenkranz is the H.J. Smead Professor and Chairman of the Department of Ophthalmology at Stanford University. He received…

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Oculeve Open Ups, Just A Little, On OD-01

OIS Podcast

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 047″] In this week’s OIS Podcast, we talk with Oculeve CEO Michael Ackermann about the start-up company that caught the eye of Dry Eye Leader Allergan. The dry eye space has taken a few hits lately with disappointing clinical news on the biopharmaceutical front. But the news that Allergan would pay…

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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…

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InnFocus

The MicroShunt has just completed enrollment (n=75) in a pivotal study, and is the only device to be directly compared to trabeculectomy. The device has been used in humans for more than 12 years outside the U.S., with mean postop pressures below 14 mmHg. The pressure reduction seen at 3 months holds through 3 years.…

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ForSight VISION5

Dedicated to solving compliance problems with ophthalmic medications, ForSight VISION5 has developed Helios, a non-invasive, sustained-release drug delivery system that remains in place for 6 months. Final data from a phase 2 study is expected by the end of the year, with plans in place for a phase 3 study in Q1 2016, and a…

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Spotlight on Pressure Reduction

Participants: Kuldev Singh, MD, MPH Dr. Kuldev Singh is Professor of Ophthalmology and Director of the Glaucoma Service at the Stanford University School of Medicine. View Full Profile Thomas A. Mitro Thomas A. Mitro has served as our President and COO since August 2013. From November 2012 to August 2013, Mr. Mitro served as Vice…

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Spotlight on Drug Delivery

“It’s becoming more like cage fighting than company building.” The Drug Delivery market is increasingly competitive. CEOs from the sector’s leading innovators Ocular Therapeutix, Kala Pharmaceuticals, Envisia Therapeutics and Icon Bioscience join in a discussion led by OIS Co-chair Emmett Cunningham, MD and K. Angela MacFarlane for ForSight Labs. Topics discussed including battling generics, protecting…

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Ocular Therapeutix

The company is evaluating sustained-release injectable anti-VEGF drug depots along with using its proprietary hydrogel platform technology for anterior segment disorders (specifically pain and inflammation). The company’s OTX drug-eluting punctal plug is a non-invasive procedure that will eliminate drops (and the potential non-compliance). Two phase 3 studies have been completed on inflammation, with 39.4% absence…

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Icon Bioscience

The company’s proprietary Verisome drug delivery technology is being used as the base for IBI-10090, for post-cataract surgery inflammation. The dexamethasone compound completed a pivotal phase 3 study (n=394), and based on these results, Icon plans to file an NDA by late 2015/early 2016. Phase 3 results builds on the phase 2b data, which showed…

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Kala Therapeutics

By penetrating the mucosal barrier in the eye, Kala’s Mucosal Penetrating Products (MPPs) “enhances pharmacokinetics” and can be used to treat both anterior and posterior segment disorders. Top-line results from a Phase 3 clinical trial of KPI-121 (loteprednol) achieved all primary efficacy endpoints in the treatment of inflammation and pain post-cataract surgery. A phase 2/3…

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Envisia Therapeutics

ENV515 is a proprietary, fully biodegradable PRINT (Particle Replication In Non-Wetting Templates) particle formulation of a prostaglandin analog, travoprost, with the potential for sustained intraocular pressure (IOP) reduction over as many as 6 months. In hypertensive beagles, a “rapid drop” in pressure was maintained over 8 months, Yerxa said, accounting for a 32% reduction in…

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Jade Therapeutics

Jade’s proprietary, cross-linked, bioerodable hydrogel technology can be used alone as an ocular lubricant, or as a sustained-release vehicle for either anterior or posterior segments. The thiolated carboxymethyl HA (CMHA-S) is “an improved version of the hyaluronic acid (HA) products on the market today for dry eye,” Klausner said. The technology can be produced as…

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