Allergan rejects revised Valeant proposal

Allergan's (Irvine, Calif.) Board of Directors has rejected the revised unsolicited proposal from Valeant Pharmaceuticals (Montreal, Canada), determining that it "substantially undervalues the company, creates significant risks and uncertainties for stockholders of Allergan, and is not in the best interests of the company and its stockholders," according to a press release from Allergan. David E.I. Pyott, chairman of the Board and CEO of Allergan, explained in a letter to Michael Pearson, Valeant's chairman and CEO, that the latest proposal undervalued Allergan and did not take into account the company's continued sale growth, its R&D, or a number of other factors.

FDA concludes that KAMRA benefits
outweigh risks

A vote at a meeting of the U.S. Food and Drug (FDA) Ophthalmic Devices Advisory Panel determined that the benefits of the KAMRA inlay (AcuFocus, Irvine, Calif.) outweigh the risks for patients with presbyopia. This panel vote will factor into the FDA's consideration of benefits and risks when determining the premarket approval of the KAMRA. Surgeons, company representatives, FDA representatives, and patients all spoke to the panel about the inlay.

IRIS Registry recognized by CMS

The IRIS Registry, the database of the American Academy of Ophthalmology (AAO), has been recognized by CMS as an approved vehicle for enhanced federal quality reporting. The AAO announced the news in a press release. The registry has also been named a qualified registry and a qualified clinical data registry (QCDR) under Physician Quality Reporting System (PQRS) designations. The IRIS Registry was officially launched in March 2014.

High blood pressure drugs could impact vision

Taking vasodilators could be related to the development of early-stage age-related macular degeneration (AMD), according to a study published in Ophthalmology. Researchers at the University of Wisconsin School of Medicine and Public Health did a long-term population-based cohort study from 1988 to 2013, which included around 5,000 residents of Beaver Dam, Wis., in the age range of 43 to 86 years old. This study was a part of the National Eye Institute (NEI) Beaver Dam Eye Study. Results of the study concluded that using any vasodilator was associated with a 72% greater risk of developing early-stage AMD. This was concluded after adjusting for age, sex, and other factors, according to a press release from the American Academy of Ophthalmology. Researchers said that the study needs to be replicated to determine the true impact.

A study partially funded by the National Eye Institute (NEI) found a link between chronic sunlight exposure and increased risks for cataracts. The study, which was led by Case Western Reserve University in Cleveland, Ohio, demonstrated that UV light can damage lens proteins in a distinct way, and this is typically seen in cataract and in cells damaged by oxidative stress, according to a press release from the NEI. Although there have been previous studies on this topic, this is the first to show a detailed play-by-play of the chemical changes that can be caused to the lens from UV light. The study helps to demonstrate the way UV light could facilitate cataract development and stresses the importance of wearing sunglasses to protect against this. 

Electrical stimulation of retinal cells has been found to produce the same patterns of activity that occur when the retina sees a moving object, according to a press release from the National Eye Institute. Research funded by the National Institutes of Health has shown these results in lab tests. Researchers at Stanford University have been targeting specific cells in the retina to look at the way that artificial vision technology can help some people blinded by retinitis pigmentosa to regain some of their sight. The study was published in Neuron, and was funded in part by NIH's National Eye Institute and National Institute of Biomedical Imaging and Bioengineering. Natural vision requires the right cells to be activated at the right time, and the new study seeks to explore options for this. 

RESEARCH BRIEFS

• Certain patients with limbal stem cell (LSC) disease may find that their condition is reversible. Bryan Y. Kim and colleagues detailed a retrospective case series exploring the clinical features and management strategies for patients whose disease may be reversed with medical therapy. The results of 22 eyes of 15 patients were reported in Ophthalmology. In the study, the corneal epithelial phenotype returned to normal with conservative measures, including lubrication and discontinuing contact lens wear in 4 eyes of 4 patients. However, in 18 eyes of 11 patients, additional interventions were required after at least 3 months of conservative therapy. Medical interventions used included topical corticosteroids, topical cyclosporine, topical vitamin A, oral doxycycline, punctal occlusion, or a combination thereof. After a mean follow-up of 15 months, all eyes in the study had achieved a stable ocular surface, and visual acuity improved from a mean of 20/42 to 20/26 (P<0.0184).  

• Visual acuity improvement and side effects were the topic of a study that looked at ranibizumab, bevacizumab, and aflibercept in age-related macular degeneration (AMD). Martin K. Schmid and colleagues sought to quantify these two factors as they relate to debates on which of these 3 anti-VEGF treatments is the optimal choice to treat AMD. The study, published online in the British Journal of Ophthalmology, used a number of resources, including PreMEDLINE, EMBASE, SCOPUS, Cochrane Library (until April 2013), Science Citation Index, and reference lists, to find placebo-controlled randomized trials or other comparisons of the 3 anti-VEGFs. Results looked at 11 trials with a total of 8,341 patients and 5 active treatments. In comparison to the placebo, all of the anti-VEGF treatments had a higher percentage of visual acuity letters gained. Other results depended on the specific concentrations of the anti-VEGF administered. The study concluded that there was only a modest superiority of aflibercept 2 mg and ranibizumab 0.5 mg over other formulations and dosages.

• A phase 1/2 study addressed the treatment of exudative age-related macular degeneration (AMD) with a designed ankyrin repeat protein (DARPin) to bind vascular endothelial growth factor. Eric H. Souied and colleagues evaluated the safety, tolerability, and bioactivity of doses of the MP0112 DARPin. Published in the American Journal of Ophthalmology, it was an open-label, multicenter, dose escalation study with patients receiving one intravitreal injection of MP0112 in a dose that ranged from 0.04 to 3.6 mg. Patients were monitored for 16 weeks after injection. In total, 32 patients received a dose of MP0112, with 1.0 mg being the maximum tolerated dose. Results indicated that visual acuity scores were stable or improved compared with baseline for ≥4 weeks following injection; additionally, both retinal thickness and fluorescein angiography leakage decreased, depending on the dose. The study saw mean decreases in retinal thickness and leakage area with a single injection of 1.0 or 2.0 mg MP0112, although there was some ocular inflammation. It was also noted that larger studies are needed to further explore the
  results reported.