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Volume 22, Number 6 |
10 February 2017 |
The U.S. Food and Drug Administration (FDA) has cleared the new, investigational drug application for Aura Biosciences' light-activated AU-011 (Cambridge, Massachusetts), a therapy to treat ocular melanoma. The drug is part of a new class of therapies focused on targeting and selectively destroying cancer cells using viral nanoparticle conjugates, according to the company. "Early detection of ocular melanoma, combined with the administration of AU-011 as a potential vision-sparing therapy, could transform the treatment of patients with this devastating disease," said Brian Marr, MD, director of the Ophthalmic Oncology Service, Columbia University Medical Center, New York. Dr. Marr is a member of Aura's Clinical Advisory Board and the principal investigator for the AU-011 clinical trial, according to a company press release. The Phase 1b clinical trial is currently enrolling patients and is designed to analyze the safety, immunogenicity, and preliminary efficacy of two dose levels of AU-011 to treat small-to-medium primary ocular melanoma. Screening for eligible patients is taking place at five clinical sites around the U.S., according to Aura Biosciences.
Allergan (Dublin, Ireland) has announced a new program called See America to make vision health a priority, increase the awareness of diseases that cause preventable blindness, and help improve access to vision care. The efforts behind See America come on the heels of a fall 2016 report from the National Academies of Sciences, Engineering, and Medicine that declared eye health a public health initiative. Allergan will collaborate with the organization Prevent Blindness (Chicago) to promote better access to vision care and sponsor a series of vision-screening events around the U.S. Attendees will receive free, one-on-one professional eye exams, follow up, and education.
Interim analysis of the second cohort of a Phase 2 trial for ENV515 (travoprost XR) in glaucoma patients found a clinically meaningful decrease in IOP for the 11-month evaluation period after a single dose, according to Envisia Therapeutics (Research Triangle Park, North Carolina). Compared to pre-study topical prostaglandin analogs (Xalatan, latanoprost, Pfizer, New York, and Lumigan, bimatoprost, Allergan), ENV515 also had an IOP-lowering effect, Envisia reported. There was also an IOP-lowering effect compared with in-study topical timolol maleate 0.5% daily eye drops. "These 11-month results demonstrate that ENV515 could achieve once-a-year dosing frequency, which would be very meaningful improvement over currently available daily therapies," said Thomas Walters, MD, the lead investigator for ENV515's Phase 2 trial, in a press release. The ongoing second cohort of the Phase 2 trial is a year-long safety and efficacy evaluation enrolling five glaucoma patients at sites around the U.S. ENV515 is an extended-release formulation of a marketed prostaglandin analog.
An integrated services center to help infants and children with glaucoma has opened at Bascom Palmer Eye Institute, which is part of the University of Miami Health System in Miami. The Samuel & Ethel Balkan International Pediatric Glaucoma Center includes a clinical team that offers comprehensive glaucoma care for children, leading diagnostic technology, genetic screening, and a new Global Eye SITE program, which is dedicated to training skilled surgeons from underserved countries. The new Balkan Center is also home to the Childhood Glaucoma Research Network, an international group with more than 200 ophthalmologists from around the world who are focused on advanced pediatric glaucoma research, according to a Bascom Palmer press release.
Iluvien (Alimera Sciences, Alpharetta, Georgia) is now fully reimbursable in Italy in patients who have previously had cataract surgery. Iluvien is a sustained-release intravitreal implant with the CE Mark in Europe used in to treat vision impairment from chronic diabetic macular edema. Iluvien received FDA approval in 2014.
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