What’s Happening in the Month Ahead: October 2017
The Food and Drug Administration along with a host of professional societies, including the American Academy of Ophthalmology, American Society of Cataract and Refractive Surgeons, and American Society of Retina Specialists, are hosting the Ophthalmic Digital Health Workshop October 23 in Gaithersburg, MD. The workshop will provide the background and regulatory framework for ophthalmic Digital Health, and inform practical approaches that balance benefits and risks of wireless medical devices, mobile medical apps, health IT, telemedicine, medical device data systems, medical device interoperability, software as a medical device (SaMD), and cybersecurity. Listen to the OIS Podcast with panelist Mark S. Blumenkranz, MD.
Aerie Pharmaceuticals will meet with the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee on October 13 to review its New Drug Application (NDA) for Rhopressa (netarsudil ophthalmic solution 0.02%) for open-angle glaucoma or ocular hypertension. Aerie submitted the Rhopressa NDA in February. The FDA set a PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018, to complete its review of the Rhopressa NDA.
Applied Genetic Technologies Corporation (AGTC) president and CEO Sue Washer will deliver a couple of presentations this month: at the Alliance for Regenerative Medicine Cell & Gene Meeting on the Mesa, La Jolla, CA, October 4–6 (where she will also moderate the panel discussion “Gene Therapy: Building the Gene Medicine Pipeline Through Next Generation Technologies”); and she will participate in an analyst-led fireside chat at the Chardan Gene Therapy Conference in New York, October 10, and will be a panel member in a discussion titled “Gene Therapies: Pricing and Other Commercial Considerations.”
Aldeyra Therapeutics, whose lead product candidate, ADX-102, is an aldehyde trap in development as topical eye drops for the treatment of ocular inflammation, will host a research and development day October 10 in New York to discuss new clinical results from its Phase II clinical trials in allergic conjunctivitis and dry eye disease, as well as market opportunities in ocular inflammation. Presenters will include John Sheppard, MD, professor at Eastern Virginia Medical School and president of Virginia Eye Consultants; Gary Novack, PhD, president, PharmaLogic Development and visiting professor at University of California, Davis, School of Medicine; and Tim Surgenor, partner at Red Sky Partners, LLC.