FDA Q&A

Food and Drug Administration to adopt guidelines and standards to help expedite approvals. Two key players within the agency, Dr. Wiley Chambers and Dr. Malvina Eydelman, sat down for an open Q&A with Emmett Cunningham, MD, co-chair of OIS@AAO. Dr. Eydelman is director of the Division of Ophthalmic and Ear, Nose and Throat Devices, and…

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Second Acts – Reinventing Your Company

Building a successful biotech or biopharma company typically turns on a sentinel event – the pivot, as William J. Link, PhD, Managing Director of Versant Ventures calls it. That can involve a complete shift in a company’s focus. Link hosted a panel at the Ophthalmology Innovation Summit in Chicago, where CEOs and founders explained how…

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Mati Therapeutics

Mati Therapeutics Inc. is an early-stage company addressing the massive glaucoma market. Founder and CEO Robert Butchofsky discussed the main challenges to all glaucoma-focused sustained drug delivery platforms, and described Mati’s solution: the Evolute minimally invasive, sustained-delivery platform, which uses punctum plugs to deliver drugs for ocular diseases, particularly glaucoma. Evolute will enter a Phase…

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Neurotech

Quinton Oswold, President and CEO of Neurotech Pharmaceuticals Inc., sees huge opportunity both in wet AMD and diabetic macular edema patients who need more extensive and longer lasting therapies. Neurotech’s Encapsulated Cell Technology (ECT) platform provides long-term continuous delivery (2+years) of protein drugs directly into the vitreous of the eye. The company is developing multiple…

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Alimera Sciences

Alimera Sciences Inc. is ready to launch in the US its recently approved intravitreal implant, Iluvien, for treating diabetic macular edema. President and CEO Dan Myers reported the company has a direct sales force of 32 reps ready for the product’s commercial debut in Q1 2015. Iluvien delivers a corticosteroid, providing sustained therapeutic effect for…

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Biopharma Companies of All Stages Shine in OIS Showcase

Biopharmaceutical development has gone well beyond the drugs themselves to mechanisms and platforms that aim to deliver those drugs more effectively and precisely than existing platforms, as nearly 800 attendees at the Ophthalmology Innovation Summit in Chicago heard during the BioPharma Showcase. Read the key takeaways below on the companies that presented, and watch the…

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Eye Companies Helping Health Care Stand Out

Healthcare stocks are outperforming the indices, and ophthalmic companies are helping to fuel a large part of that growth, Jeffrey Hoffman, Managing Director and Head of West Coast Healthcare Investment Banking for J.P. Morgan, told attendees at the Ophthalmology Innovation Summit in Chicago. “Healthcare has outperformed most other sectors, and it has been primarily driven…

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CEOs Share Their ‘Second Acts’ On Way to Building Successful Companies

Building a successful biotech or biopharma company typically turns on a sentinel event — the pivot, as William J. Link, PhD, Managing Director of Versant Ventures calls it. That can involve a complete shift in a company’s focus. Link hosted a panel at the Ophthalmology Innovation Summit in Chicago, where CEOs and founders explained how…

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MC2 Biotek Group Offers Insights on PAD

MC2 Biotek Group’s Co-Founder and President Jesper J. Lange updated attendees on the company’s PAD technology, which may make existing drugs easier to use. The company’s lead product PADciclo is beginning Phase II testing against dry eye. MC2 Biotek has a collaboration with Moorfield Pharmaceuticals (part of Moorfield Eye Hospital) to develop a cyclosporine formulation…

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Avalanche Biotechnologies Gives Ocular BioFactory Tour

Thomas W. Chalberg, PhD presented an update on Avalanche Biotechnologies Inc.’s pipeline of products emerging from its integrated gene therapy discovery, development, and manufacturing platform, Ocular BioFactory. Avalanche’s lead product, AVA-101, is undergoing Phase IIa clinical trials for wet AMD; the company could submit an investigational new drug applications in the second half of 2015.…

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Allegro Gives Phase II News on Luminate

[creativ_media type=”vimeo” url=”https://vimeo.com/110730931″] Vicken Karageozian, MD, Co-Founder and CTO of Allegro Opthalmics LLC, updated the OIS audience on the clinical trial progress of Luminate, a first-in-class integrin peptide therapy that treats vitreo-retinal diseases by utilizing two mechanisms of action, anti-angiogenesis and vitreolysis. The company just initiated a Phase II study of the drug as a…

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Ophthotech Shares Late-Stage Progress of Fovista

CEO David R. Guyer, MD reports that Phase III clinical trials of Ophthotech Corp.’s Fovista, a first-in-class anti-PDGF agent for wet AMD combination therapy, are on track. The company expects to receive top-line data in 2016. Meanwhile, Ophthotech is partnering with Novartis to sell Fovista outside the US. The deal could be worth $1 billion…

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