Aquesys

The XEN Gel Stent is made of a permanent, soft, collagen-derived, gelatin about 6 mm long. Upon implantation, it creates a gentle, diffuse outflow of aqueous from the anterior chamber into the non-dissected tissue of the subconjunctival space. The ab-interno procedure requires no tissue dissection or suturing. Although the device creates a bleb, there are…

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Lifitegrast Heads Up Promising Dry Eye Pipeline

For more than a decade, there has only been one approved pharmacologic treatment for dry eye—Allergan’s Restasis (topical cyclosporine 0.05%). This in a market estimated to be worth more than $2.4 billion, one that affects up to 100 million people worldwide, and one that is expected to grow by almost 3% yearly. Dry eye products…

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Visual Disorders In Space And How Ophthalmology Can Help

View PDF Presentation Presenter: Dorit B. Donoviel, PhD Dr. Donoviel oversees the diverse portfolio of science and technology research and development projects at NSBRI that address the challenges faced by humans in space. She leads the NSBRI Industry Forum and the SMARTCAP seed award program for commercialization of biomedical technologies co-developed for both space and…

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Alimera CEO Myers Shares Lessons From Iluvien FDA Approval

OIS Podcast

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 018″] The FDA turned away Alimera Sciences’ bid to market Iluvien as a treatment for diabetic macular edema three times before finally giving the green light. President & CEO Dan Myers shares what kept his confidence up during this lengthy review and how Alimera Sciences is positioning Iluvien in the DME…

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InnFocus

InnFocus Inc.’s MicroShunt glaucoma drainage implant is designed to reduce intraocular pressure in glaucoma patients. President and CEO Russell Trenary explained that the implant is made from a revolutionary and highly biocompatible material that is ultra-stable and does not degrade. In the past year, InnFocus has been conducting the first randomized controlled study against trabeculectomy,…

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ForSight VISION5

ForSight VISION5 Inc. CEO John Maroney discussed his company’s novel, non-invasive insert system, Helios. Placed on the surface of the eye, under the eyelid, Helios enables glaucoma and ocular hypertensive patients to continually receive medication (such as “the drug of choice” prostaglandin A), eliminating their need to regularly administer eye drops. Results from a Phase…

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Implandata Ophthalmic Products GmbH

Implandata Ophthalmic Products GmbH is developing a patient-operated, hand-held system, which works with an implantable micro sensor capable of measuring absolute intraocular pressure continuously or on demand. Company Co-founder and General Manager Max G. Ostermeier, MBA, explained that after the patient takes the measurement, the device sends the IOP data via GSM/modem to the patient’s…

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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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FDA Division Directors Detail How Agency Adapts to Innovation

The rush of innovation in ophthalmology – both in drugs and devices – is driving the 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.…

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The NEI’s Role in Innovation

The National Eye Institute (NEI) spends $675 million annually, mostly on basic science and discovery research.  In addition, said Matthew J. McMahon, PhD, Director of the agency’s Office of Translational Research, “We have a clear mandate to help translate these discoveries into clinical medicine and public health improvements.” He points to the agency’s role in…

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