Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Aerie Pharmaceuticals, Inc. reported the successful 12-month safety results of the company's "Mercury 1" Phase 3 registration trial for its fixed-dose combination product candidate, Roclatan™. Safety results for Roclatan for the 12-month period were reportedly consistent with those observed for the 90-day efficacy period in the trial. The purpose of the 12-month Mercury 1 study is to reportedly provide adequate safety data for an expected NDA (new drug application) submission to the FDA in the first half of 2018.
- Spark Therapeutics announced the U.S. FDA has accepted for filing the Biologics License Application (BLA) and granted Priority Review for voretigene neparvovec — an investigational, potential one-time gene therapy candidate for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD). The investigational gene therapy, which has the proposed trade name LUXTURNA™ (voretigene neparvovec), reportedly has the potential to be both the first pharmacologic treatment for IRD and the first gene therapy for a genetic disease in the U.S.
- BioTime, Inc. plans to host a Key Opinion Leader event on the topic of dry age-related macular degeneration (AMD) in New York City on Tuesday, July 25, 2017. The meeting will reportedly feature a presentation by key opinion leader Dr. David S. Boyer of Retina-Vitreous Associates, who will discuss the clinical perspective and cell therapy treatment options for patients with dry age-related macular degeneration.
- Alimera Sciences, Inc. announced the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has given final approval to reduce the size of its ILUVIEN Registry Safety Study (IRISS). A post-marketing study, IRISS was reportedly originally designed to follow 800 ILUVIEN patients over five years. However, consistently positive real-world safety data from IRISS and other post-marketing studies reportedly led Alimera to seek a smaller sample size.
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