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Chairman delivers year’s industry highlights at OIS

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LAS VEGAS — This year has been an innovative year in ophthalmology with several milestones being reached, including a number of FDA submissions and successful phase 3 clinical trials, according to Emmett T. Cunningham Jr., MD, PhD, MPH, who gave the “Chairman’s 2015 Year in Review” at the Ophthalmology Innovation Summit here.

Spark Therapeutics reported clinical results for RPE-65, the first phase 3 clinical trial for gene therapy for the eye. AbbVie also reported positive phase 3 trial results for Humira (adalimumab) for treatment of noninfectious uveitis.

Emmett T. Cunningham Jr.

“Remember, we have had three failed phase 3 trials in that indication, so that is an impressive feat,” Cunningham said.

There have been four premarket application approvals this year, one being for the AcuFocus Kamra intracorneal inlay, which, to date, has been implanted in more than 1,000 eyes, according to Cunningham.

Physicians who use the inlay “seem very happy with it,” Cunningham said. “They have told me that their patients are very happy with it, so I think it is a very welcomed approval.”

A milestone to look forward to is the data coming from a phase 3 trial of Fovista (pegpleranib, Ophthotech) combined with anti-VEGF for treatment of wet age-related macular degeneration, Cunningham said.

“[Fovista] is the first combination product for wet age-related macular degeneration with the PDGF inhibitor and the VEGF inhibitor,” he said.

ReVision Optics has submitted a PMA for its Raindrop corneal inlay, Transcend Medical has submitted a PMA for its suprachoroidal shunt and Oculeve has submitted a PMA for OD-01, a tear stimulation product – all milestones to look forward to in the coming year, Cunningham said. — by Nhu Te

Disclosure: Cunningham reports he is a partner at Clarus Ventures.

Reference:

Cunningham ET. Welcome and Chairman’s 2015 Year in Review. Presented at: Ophthalmology Innovation Summit. Nov. 12, 2015; Las Vegas.