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October 9, 2015

Alcon Receives FDA Approval for Pre-Loaded Intraocular Lens Delivery System

Alcon, a division of Novartis, has received U.S. Food and Drug Administration approval for its AcrySof IQ aspheric IOL with the UltraSert pre-loaded delivery system for patients undergoing cataract surgery. This new delivery system combines the control of a manually loaded device with the safety and convenience of a disposable, pre-loaded injector. The UltraSert system received the European CE mark in June 2015. The design of the UltraSert system helps to create a less invasive corneal incision during cataract surgery. The smaller nozzle tip allows for a corneal incision down to 2.2 mm for insertion of the IOL while the Depth Guard nozzle of the delivery system prevents the device from being inserted deeper into the incision than necessary, preserving the size of the original corneal incision. More information can be found at https://www.novartis.com/news/media-releases/alcon-receives-fda-approval-pre-loaded-intraocular-lens-delivery-system-treat.

pSivida Announces NDA for Medidur for Posterior Uveitis

pSivida Corp. has announced plans to file a New Drug Application for Medidur for posterior uveitis based on six-month efficacy data for both of its Phase III trials. The U.S. Food & Drug Administration has advised pSivida that this data will be acceptable for review. pSivida previously planned to utilize 12-month efficacy data from the first trial and six-month efficacy data from the second trial. Six-month visits in the first trial will be completed this month, and reports of the top-line results from the first Phase III trial are expected in December 2015. Enrollment in the second Phase III trial continues and is expected to be completed during the first half of 2016, with an NDA anticipated in the first half of 2017. More information can be found at http://psdv.client.shareholder.com/releasedetail.cfm?ReleaseID=933331.

Aflibercept Recommended for Use in Myopic CNV in European Union

The European Committee for Medicinal Products for Human Use (CHMP) has recommended aflibercept solution (Eylea, Regeneron/Bayer Healthcare) for injection into the eye for the treatment of visual impairment due to myopic CNV for approval in the European Union. The CHMP’s positive recommendation is based on the results of the Phase 3 MYRROR study in patients with myopic CNV. Patients receiving aflibercept solution for injection had a mean improvement in best-corrected visual acuity from baseline at week 24 of 12.1 letters, while patients receiving sham injections lost two letters (p<0.0001), as measured on the ETDRS eye chart. The efficacy gains seen at week 24 were maintained and even extended further in the aflibercept arm until week 48. More information can be found at http://pipelinereview.com/index.php/2015092559054/Antibodies/Bayers-Eye-Drug-Recommended-for-EU-Approval-in-Fifth-Indication.html.

Glaucoma Research Foundation Elects New Members to Board of Directors

The Glaucoma Research Foundation has named Monica L. Vetter, PhD, and Ruth D. Williams, MD, to its Board of Directors. Dr. Vetter is professor and chair of the neurobiology and anatomy department, and adjunct professor in ophthalmology and visual sciences at the University of Utah. Her lab focuses on understanding the pathways controlling neural development and degeneration in the retina. Dr. Williams is a glaucoma consultant and CEO of the Wheaton Eye Clinic in Illinois, and is a past president of the American Academy of Ophthalmology. More information can be found at http://www.glaucoma.org/news/press-releases/monica-vetter-phd-and-ruth-williams-md-join-glaucoma-research-foundation-board-of-directors.php.

Ursapharm and Novaliq Announce European Partnership and Product Launch

Ursapharm and Novaliq have entered into a partnership agreement, and have announced the initial European launch of EvoTears eye drops. As part of the agreement, Ursapharm obtains the exclusive license for the commercialization of EvoTears, Novaliq’s first commercially available ophthalmic product for the treatment of evaporative dry eye diseases. Ursapharm’s ophthalmic portfolio includes Hylo Eye Care for dry eye treatment, and a broad variety of ophthalmic products in the segments of antibiotics, anti-glaucomatosa and anti-inflammatory treatments. Bernhard Günther, PhD, co-founder, managing director and CEO of Novaliq, said, “This collaboration with Ursapharm is very important for Novaliq as it validates our technology and will result in a successful market launch in Europe.” More information can be found at http://www.novaliq.de/fileadmin/Downloads/20151001_Evotears_Licence_Agreement_with_Ursapharm.pdf.

Enhanced Medical Services Acquires Star Ophthalmic Instruments

Enhanced Medical Services (EMS), a provider of new and pre-owned ophthalmic equipment based in St. Louis, acquired Star Ophthalmic Instruments, Inc., a Midwest leader in ophthalmic equipment sales and service for 28 years. This transaction marks the second acquisition made by EMS in the past 18 months, after previously acquiring Universal Ophthalmic Instruments, Inc. in April 2014. EMS offers an array of diagnostic, laser, classical and service solutions, including new equipment and refurbished pre-owned diagnostic and lane equipment. Star Ophthalmic CEO Dan Reberski will serve as president of the Chicago division of EMS, and his wife, Denise Reberski, will serve as vice president, which will allow them to maintain long-standing customer relationships. More information can be found at http://www.emseye.com/10-01-15-ems-acquires-star-ophthalmic-instruments.html.

Ocular Therapeutix Submits NDA for Dextenza for Treatment of Post-Surgical Ocular Pain

Ocular Therapeutix, Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Dextenza (sustained release dexamethasone) 0.4mg Intracanalicular Depot, for the treatment of ocular pain following ophthalmic surgery. The data included in the NDA submission are from a Phase 2 clinical trial and two Phase 3 clinical trials conducted with this product candidate. The company’s plans for submitting the NDA and for conducting a third Phase 3 clinical trial of Dextenza were based on the results of the two completed Phase 3 clinical trials and following a pre-NDA clinical meeting with the FDA in April 2015. More information can be found at http://investors.ocutx.com/phoenix.zhtml?c=253650&p=irol-newsArticle&ID=2090846.

Aura Biosciences Forms Clinical Advisory Board and Strengthens Clinical Team

Aura Biosciences has formed a clinical advisory board in ocular oncology and bolstered its clinical development team as it prepares to initiate clinical testing of its lead program in ocular (uveal) melanoma. The clinical advisory board will include Carol Shields, MD, co-director of the oncology service at Wills Eye Hospital of Thomas Jefferson University in Philadelphia; Evangelos Gragoudas, MD, director of the retina service at the Massachusetts Eye and Ear Infirmary of Harvard University in Boston; and Arun D. Singh, director of the department of ophthalmic oncology in the Cole Eye Institute at the Cleveland Clinic. This board will help guide the clinical development of AU-011, Aura’s lead program in ocular melanoma. Additionally, Aura has appointed Denis O’Shaughnessy, PhD, to the position of vice president of clinical development. Dr. O’Shaughnessy has led the clinical development of multiple ophthalmology products over the past two decades in roles at Hoffman-LaRoche, Eyetech Pharmaceuticals, OPKO Health, and Oraya Therapeutics. More information can be found at http://www.businesswire.com/news/home/20150930005169/en/Aura-Biosciences-Forms-Clinical-Advisory-Board-Ocular#.VhLfYnhYZFJ.

Nemus Selects Distinguished Physician-Scientist to Chair Ophthalmology Advisory Board

Nemus has announced that Robert N. Weinreb, MD, has joined the scientific advisory board of Nemus Bioscience, Inc. including chair of the ophthalmology board. Dr. Weinreb, a graduate of Harvard Medical School, is chairman and distinguished professor of ophthalmology at the University of California, San Diego, and also serves as director of the Shiley Eye Institute. Dr. Weinreb’s research interests have focused on glaucoma, optic neuropathies, and disorders associated with the aging eye. CEO and CMO Brian Murphy, MD, MPH, said, “Nemus is committed to advance the field of ocular therapeutics by introducing a new class of medicines derived from cannabinoid-based molecules. Development of these compounds has previously shown benefits in reducing intraocular pressure, especially in the setting of glaucoma, as well as neuroprotective qualities.” He said Nemus will continue to add to their ophthalmology team as they advance their first candidate molecule for glaucoma, NB1111, a prodrug of THC, through development. More information can be found at http://www.nemusbioscience.com/robertnweinreb.html.

Physician CEO Announces Affiliation with AECOS

The Physician CEO program, an intensive CEO-level certificate program designed exclusively for physicians with an emphasis on practice growth, has formed an affiliation with the American-European Congress of Ophthalmic Surgery. Physician CEO was developed by SurgiVision Consultants, Inc. in collaboration with the Kellogg School of Management at Northwestern University. The program has an explicit entrepreneurial focus on leadership, finance, negotiations, operations, strategy and innovation, and immerses physicians in these core business skills. More information can be found at http://www.businesswire.com/news/home/20151001005560/en/PHYSICIAN-CEO-Announces-Affiliation-American-European-Congress-Ophthalmic#.VhLqg3hYZFJ.

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