Iluvien, a promising sustained drug delivery system for the treatment of diabetic macular edema, fails to pass FDA scrutiny…but there’s hope.
Category: Retina
CATT Study Update 12: Status of WorldWide Studies
With the anticipated arrival of the one-year results of the CATT Study this Spring, I thought it would be appropriate to update where the other worldwide studies stand.During the Retina Subspecialty Day sessions, held prior to the recent 2010 AAO Meeti…
Iluvien Update: FDA Marketing Approval Delayed
Last July, I wrote a comprehensive report about Iluvien and the status and promise of other sustained release drug delivery systems (Iluvien and the Future of Ophthalmic Drug Delivery Systems). At that time, Alimera Sciences, the company developing Ilu…
Omega-3-Rich Fish and Shellfish May Protect Against Advanced AMD
The consumption of omega-3-rich fish and shellfish
may protect against advanced AMD, according to a study
in Ophthalmology.1
Bonnielin K. Swenor, MPH, of the Wilmer Eye Institute,
Johns Hopkins University, Baltimore, and colleagues conducted
a cross-se…
Study Linking Vaccines to Autism Was Fraud
A study published in The Lancet in 1998 linking the
measles, mumps, and rubella (MMR) vaccine to autism
was “an elaborate fraud,” according to a report in the
BMJ.1
The study,2 published February 28, 1998, was authored
by Andrew Wakefield, MD, and …
Ranibizumab Approved in EU For Vision Loss Due to Diabetic Macular Edema
The European Medicines Agency (EMEA) has granted
Novartis (Basel, Switzerland) a new, broader indication for
ranibizumab (Lucentis, Genentech) to treat patients with
visual impairment due to diabetic macular edema (DME),
according to a company news rel…
Resequencing Chip Detected 90 Retinal Disease Genes
A group of researchers in the Netherlands have developed
a resequencing chip to detect known and new
sequence changes in 90 retinal disease genes, according
to a study in Ophthalmology.1 The chip is capable of
screening multiple genes simultaneously.
R…
Advanced Cell Technology Receives FDA Clearance to Initiate Clinical Trials
Advanced Cell Technology, Inc. (Santa Monica, CA)
announced that it received clearance from the US Food
and Drug Administration (FDA) for the company’s
Investigational New Drug application to treat dry AMD
using retinal pigment epithelial (RPE) cells…
Prevalence of AMD on the Decline in US Adults
The prevalence of age-related macular degeneration
(AMD) in US adults is significantly lower today than it
was 15 years ago, according to the results of a nationally
representative, population-based, cross-sectional study
published in the Archives of O…
Ifa Systems AG Aquires Inoveon Corporation
Ifa Systems AG (Cologne, Germany), a provider of software
applications in international ophthalmology,
announced the acquisition of Inoveon Corp. (Oklahoma
City, OK), which specializes in detection, staging, and
monitoring of diabetic retinopathy and m…
Postoperative Oral Steroids Reduced Subretinal Fluid
Postoperative systemic steroid treatment decreased the
incidence and facilitated the absorption of subretinal fluid (SRF), according to a study in Retina.1 Patients treated
with steroids also had a greater improvement in BCVA.
In the prospective, inter…
Ozurdex Reduced Inflammation, Improved Visual Acuity in Uveitic Eyes
The Ozurdex dexamethasone intravitreal implant
(Allergan, Inc.) significantly improved intraocular inflammation
and visual acuity in patients with noninfectious
intermediate or posterior uveitis, according to a study in
the Archives of Ophthalmology.1
…
Case Western Reserve University Receives NEI Grant
The Departments of Pharmacology and
Ophthalmology and Visual Sciences at Case Western
Reserve University (CWRU) School of Medicine have
received a $10.1 million grant from the National Eye
Institute (NEI) to research and develop new treatments
for reti…
Bevacizumab Reduced Incidence of Postoperative Recurrent Vitreous Hemorrhage in Small Study
One intravitreal injection of bevacizumab (Avastin,
Genentech) reduced the incidence of recurrent postoperative
vitreous hemorrhage after diabetic vitrectomy,
according to a study in Retina.1
Rizwan A. Cheema, MD, FRCS, FRCOphth, of the
Dhahran Eye Spe…
ADHD Rates Rose Among US Children
Nearly one in 10 children in the United States aged 4 to
17 years has been diagnosed with attention-deficit/hyperactivity
disorder (ADHD), according to a recent survey by
the Centers for Disease Control and Prevention (CDC).1
The results suggest that a…
FDA Issues Complete Response Letter to Alimera Sciences Regarding New Drug Application for ILUVIEN
Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it received a Complete Response Letter (CRL) from the U.S. Food a…
3 Causes of Flashes of Light
The cause of flashes of light are often due to a posterior vitreous detachment, but there other possibilities, too.
Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Phase 3 Study in CRVO and in Phase 2 Study in DME
Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the COPERNICUS study, which is led by Regeneron, the first of two Phase 3 studies in patients with m…
Lpath Grants Pfizer Exclusive Option for Worldwide License for AMD Treatment iSONEP
Lpath, Inc. has entered into an agreement providing Pfizer with an exclusive option for a worldwide license to develop and commercialize iSONEP Lpath’s lead monoclonal antibody product candidate, which is being evaluated for the treatment of wet age-…
Lifestyle Changes May Avert Age-Related Macular Degeneration
Modifying lifestyles might reduce the risk for early age-related macular degeneration as much as 3-fold, lowering the risk for advanced macular degeneration in a person’s lifetime and societal costs. Medscape Medical News