David Muller came close to writing the final chapter of Avedro’s push to have corneal cross-linking approved by the FDA. But he opted to leave the company before the final approval came through to pursue a new venture called Allotex. In this interview with OIS Podcast, Muller explains his decision to leave Avedro and tells us why he’s excited about this new entrepreneurial endeavor.
OIS Correspondents Michelle Dalton and Richard Kirkner pool their insights on the most compelling sights and insights of OIS, Subspecialty Day and AAO. The two scribes opine on exiting new disease targets, advances in drug delivery, the penetration of digital technology and why the `Pfizergan’ deal makes sense for ophthalmology.
Allergan has been a pillar of the ophthalmology sector for decades, so it’s merger with Pfizer is creating some concern along with great optimism. But ophthalmology leaders also see the opportunity for potential in the combination. The deal could bring greater firepower to ophthalmology R&D and M&A and some hope it’s a harbinger of more things to come for the sector.
Elisabeth “Eli” de los pinos was enjoying her job at Eli Lilly’s Oncology Business Unit where she was part of the leadership team responsible for Alimta’s market launch in Europe, a new drug for the treatment of Lung cancer. But she took the leap, leaving corporate comfort to build Aura Biosciences from the ground up around viral-like synthetic nanoparticles that are closely related to wild type viruses in structure and behavior but lack any viral DNA. These empty protein shells resemble viruses but do not have the capability to replicate or integrate. Aura is leverage the technology to create AU-011, which can deliver potent cell-killing laser-activated molecule right to the point of ocular cancer. Aura says the molecule is activated by a standard ophthalmologic laser and treatment will be administered in an outpatient visit.
Guests: Liliana Werner, M.D., Ph.D. Associate Professor John A. MoranEye Center University of Utah Salt Lake City, Utah Gerd U. Auffarth, MD, FEBO Chairman Department of Ophthalmology University of Heidelberg Heidelberg, Germany
The Ophthalmology Innovation Summit hit it big in Las Vegas prior to the industry’s American Academy of Ophthalmology Annual Meeting. With close to 1,000 registered attendees, OIS@AAO brought innovators together with both public and private investors as well as corpo-rate leaders of our dynamic sector. OIS Podcast walks through the agenda, hitting upon the highlights that include comments from OIS and industry leaders.
Eleven Biotherapeutics last spring issued some disappointing news when its leading project, EBI-005 didn’t fare well in a Phase III trial for Dry Eye. However, the company’s AMP-Rx platform is chugging along and its EBI-005 is making progress against other conditions including allergic conjunctivitis. CEO and President Abbie C. Celniker, PhD, updates OIS Podcast listeners on the pipeline and shares how the company is preparing for the oncoming conference season, which starts with OIS.
Dry eye remains one of the more dynamic sectors of ophthal-mology with Shire’s recent news about its lead Lifitegrast product moving toward FDA approval. Ora knows Dry Eye better than most, and Vice President George Ousler helps fill in the blanks about Dry Eye’s future. Ora also published a paper in the October issue of Review of Ophthal-mology, Delving into the Dry-Eye Pipeline. To access the paper, go here. http://www.oraclinical.com/articles/delving-dry-eye-pipeline
Avedro’s long saga with the FDA continues. Last week, the firm resubmitted the NDA for its riboflavin ophthalmic solution/KXL System, which should be the final step toward the company securing FDA approval. Founder and CEO David Muller explains how the Avedro worked to overcome the latest setback and how he, as the company’s leader, manages expectations of employees, investors, and customers as the company suffers delay after delay. He also gives an update on Avedro’s promising Photorefractive Intrastromal Cross-Linking (PiXL) refractive technology and explains what he learned about himself while running a dairy farm in Vermont.
In July, Biogen signed a potential $1 billion-plus deal with Applied Genetic Technologies Corp. The deal, which included an equity investment, centered around AGTC’s leading gene therapy programs developing treatments for rare ophthalmic conditions X -Linked Retinoschisis (XLRS) and X-linked Retinitis Pigmentosa (XLRP). In this podcast, Josh Mandel-Brehm, Director, Business Development and M&A at Bio-gen,discusses how Biogen and AGTC spoke for over a year before the deal came together. Calling the eye, “the window into the brain,” Mandel-Brehm says neurology-focused Biogen might be looking to find new partners in the future.
Jeffrey D. Marrazzo, Co-Founder and CEO of Spark Therapeutics, discusses the successful Phase III trial of its lead candidate, SPK-RPE65, was able to improve functional vision in patients with a rare form of a genetic disorder known as RPE65-mediated inherited retinal dystrophies. SPK-RPE65 is intended to treat rare blinding conditions caused by mutations in the RPE65 gene, which is linked to subtypes of Leber congenital amaurosis (LCA type 2) and retinitis pigmentosa (RP type 20). Wall St. approved as well--Spark shares rose almost 60% to $70 in trading before the market opened the day of the announcement. The study results represent the first successful randomized, controlled Phase 3 trial ever completed in gene therapy for a genetic disease, Spark executives said.
Implandata Ophthalmic Products GmbH is putting the task of tracking intraocular pressure into the hands of patients. Company Co-founder and General Manager Max G. Ostermeier shares the story of EyeMate, an implantable micro sensor capable of measuring absolute intraocular pressure continuously or on demand.
Ehsan Sadri, M.D., FACS, FAAO discusses the impact MIGS will have on ophthalmology practices and offers his insights on how ophthalmologist will handle pressure from Obamacare and other external forces going forward.
Kurt Riegger, President and COO of OcuSciences, tells a start-up’s tale. OcuSciences’ OcuMet Beacon is being developed to give optometrists and ophthalmologies the ability to see the onset of disease earlier than ever.
Imprimis Pharmaceuticals is disrupting the compound pharmaceutical industry, a segment of health care that’s undergoing significant regulatory upheaval. The company’s line of ophthalmology drugs could reduce or eliminate the need for post-surgical eye drops. Its approach is drawing support from many, including Dr. Richard Lindstrom, who serves on the company’s board.
Australia-based Opthea is moving forward with clinical trials in the US, testing its OPT-302 compound along and in combination with Lucentis as a potential treatment for Wet AMD. CEO Megan Baldwin explains the company’s approach up until now and its plans going forward.
Josh Makower, MD, literally wrote (or co-wrote) the book on Medtech Innovation. Makower is a general partner in New Enterprise Associates most recent fund, but he’s worked with the firm as a Venture Partner or EIR since 1995. Makower founded ExploraMed I, II, III, and IV Inc., a se-ries of NEA portfolio medical device incubators based on the West Coast that have created eight companies over the past 20 years. He also is co-founder of Stanford’s Biodesign Innova-tion Program.
Guests: Vaishali Vasavada, MD Consultant Ophthalmologist Raghudeep Eye Hospital Ahmedabad and Jaipur, India Ronald Yeoh, FRCOphth, DO(Lon),FAMS Medical Director Eye & Retina Surgeons, Camden Medical Centre Singapore
MIGs leader Glaukos Corp. raised over $100 million in an IPO to expand its already command-ing reach in the white hot MIGs Market. Now the company commands a market capitalization close to $1 billion, enriching the venture investors who committed more than $100 million in ven-ture capital to the company. CEO Thomas Burns explains how Glaukos got where it is today and where he sees it – and the entire MIGs market - going.
We’re thrilled to be celebrating the one-year anniversary of the OIS Podcast. We hope you enjoyed these tales of innovation as much as we have. To celebrate milestone we reveal and review the interviews that most resonated with our listeners. We re-viewed numbers Six through Ten in our last episode. In this episode, we’ll review the five most listened to podcasts, including one interview with a guest who appeared in last week’s review.
We’re thrilled to be celebrating the one-year anniversary of the OIS Podcast. We hope you enjoyed these tales of innovation as much as we have. To celebrate milestone we reveal and review the interviews that most resonated with our listeners.
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, Stan-ford University. Mark S. Blumenkranz is the H.J. Smead Professor and Chairman of the De-partment of Ophthalmology at Stanford University. He received his Baccalaureate, Master of Medical Science, and MD degrees at Brown University, followed by a Residency in Ophthalmol-ogy at Stanford. Dr. Blumenkranz is a noted vitreoretinal surgeon who served as Co-Director of the Retinal Service at Stanford for five years prior to assuming the Chairmanship in November 1997.
Guests: Farhad Hafezi, MD, PhD Professor and Chair of Ophthalmology University of Geneva Switzerland Richard Davidson, MD Associate Professor Department of Ophthalmology University of Colorado School of Medicine Aurora, CO
OIS Co-Chair Emmett Cunningham explains how Clarus will invest new $500m fund in ophthalmology and beyond. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.
Oculeve CEO Michael Ackermann Talks About Allergan’s Big Move in Dry Eye. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.
Bausch &Lomb Surgical’s Andrew Chang Has Big Plans in Ophthalmology Surgical. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.
Guests: Jorge Alio, MD Professor and Chairman of Ophthalmology University of Alicante University Miguel Hernandez de Elche John Kanellopoulos, MD Professor of Ophthalmology NYU School of Medicine New York, NY Director, Laservision Institute Athens, Greece
Valeant CEO J. Michael Pearson tells OIS attendees how the controversial company finds new technologies. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.
Leonard Borrmann, head of R&D at AMO, explains how the company encourages “failing forward” and other innovative qualities to creating new vision devices. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.
Veteran Ophthalmology Scribes Larry Haimovich of Haimovitch Medical Technol-ogy Consultants and Mike Lachman of EyeQ Research put down the pens and pick up the Mics to share their insights on ophthalmology.