Regeneron Pharmaceuticals and Bayer HealthCare announced that in two parallel Phase III studies in patients with the neovascular form of age-related macular degeneration, all regimens of VEGF Trap-Eye (aflibercept oph-thalmic solution), including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. The primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab.
Bayer HealthCare and Regeneron plan to submit regulatory applications for marketing approval in Europe and the
In the North American VIEW 1 study, 96 percent of patients receiving VEGF Trap-Eye 0.5 mg monthly, 95 percent of patients receiving VEGF Trap-Eye 2 mg monthly, and 95 percent of patients receiving VEGF Trap-Eye 2 mg every two months achieved maintenance of vision compared to 94 percent of patients receiving ranibizumab 0.5 mg dosed every month. In the international VIEW 2 study, 96 percent of patients receiving VEGF Trap-Eye 0.5 mg monthly, 96 percent of patients receiving VEGF Trap-Eye 2 mg monthly, and 96 percent of patients receiving VEGF Trap-Eye 2 mg every two months achieved maintenance of vision compared to 94 percent of patients receiving ranibizumab 0.5 mg dosed every month. Visual acuity was measured as a score based on the total number of letters read correctly on the ETDRS eye chart over 52 weeks. Maintenance of vision was defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS eye chart.
"The currently available anti-VEGF therapies have significantly advanced the treatment of wet AMD, actually improving vision in many patients. However, monthly injections are required to optimize and maintain vision gain over the long-term," said Ursula Schmidt-Erfurth, MD, professor and chair of the Department of Ophthalmology at the
"In an effort to avoid the inconvenience of monthly office visits and the burden of monthly injections into the eye for their wet AMD patients, retinal specialists have tried to extend the benefits of the existing anti-VEGF therapy with less frequent dosing. A growing body of data suggests that this practice may result in inconsistent visual acuity outcomes," said Jeffrey Heier, MD, a clinical ophthalmologist and retinal specialist at Ophthalmic Consultants of Boston, assistant professor of ophthalmology at Tufts School of Medicine, and chair of the Steering Committee for the VIEW 1 trial. "A critical goal of these studies was to demonstrate that VEGF Trap-Eye could achieve robust improvements in vision and maintain them over time with a more convenient every-other-month dose. Achievement of this goal could be important for patients, care givers and physicians."
In the VIEW 1 study, patients receiving VEGF Trap-Eye 2 mg monthly achieved a statistically significant greater mean improvement in visual acuity at week 52 versus baseline (secondary endpoint), compared to ranibizumab 0.5 mg monthly; patients receiving VEGF Trap-Eye 2 mg monthly on average gained 10.9 letters, compared to a mean 8.1 letter gain with ranibizumab 0.5 mg dosed every month (p<0.01). All other dose groups of VEGF Trap-Eye in the VIEW 1 study and all dose groups in the VIEW 2 study were not statistically different from ranibizumab in this secondary endpoint.
A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The incidence of ocular treatment emergent adverse events was balanced across all four treatment groups in both studies, with the most frequent events associated with the injection procedure, the underlying disease and/or the aging process. The most frequent ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage and vitreous floaters. The most frequent serious non-ocular adverse events were typical of those reported in this elderly population who receive intravitreal treatment for wet AMD; the most frequently reported events were falls, pneumonia, myocardial infarction, atrial fibrillation, breast cancer and acute coronary syndrome. There were no notable differences among the study arms.
In the second year of the studies, patients in VIEW 1 and VIEW 2 will continue to be treated with the same dose per injection as in the first year but administered only every three months, or more often for any worsening of AMD, based on protocol-defined criteria (called "quarterly capped PRN" dosing).
Corneal Arcus Associated with Increased IOP
Corneal arcus appears common among middle-age and older adults and may be associated with elevated eye pressure, according to a report in the November Archives of Ophthalmology.
"The accuracy of intraocular pressure measurement is crucial in the diagnosis and management of glaucoma," the authors write. Some characteristics of the cornea, including its thickness at the center and the radius of its curve, are known to affect the accuracy of this measurement.
The effect of corneal arcus—an area of lipid deposition that creates a ring around the cornea and may be associated with cardiovascular disease—on the structure and function of the cornea and on intraocular pressure is not well understood. Renyi Wu, MD, PhD, of the Singapore Eye Research Institute, and colleagues examined the prevalence and consequences of corneal arcus among 3,015 individuals age 40 to 80. Participants underwent an interview and eye examinations, including corneal measurements, assessment of intraocular pressure and identification of corneal arcus using a slit lamp.
Corneal arcus was present in the right eyes of 1,747 participants (57.9 percent). After adjustments for age, sex and other factors, eyes with corneal arcus tended to have higher intraocular pressure, thicker corneas and altered corneal curvatures. The prevalence of high eye pressure but not of glaucoma was higher among participants with corneal arcus than those without (3.2 percent vs. 1.8 percent).
"There is no known explanation for the association of corneal arcus with higher intraocular pressure," the authors write. "There may be changes in biomechanical properties of the cornea in eyes with corneal arcus, as such mechanisms are emerging as important clinical variables that may affect intraocular pressure measurements.
"Further research is required to investigate the clinical implications of these findings for [IOP] assessment in eyes with corneal arcus," the authors conclude.
Multifocal CL May Reduce Vision in Night Driving
Older adults who wear multifocal contact lenses to correct problems with near vision may have greater difficulty driving at night than their counterparts who wear glasses.
According to an article published in Investigative Ophthalmology & Visual Science ("The Effect of Presbyopic Vision Corrections on Nighttime Driving Performance"), wearing multifocal contact lenses resulted in significantly slower driving speeds at night than wearing progressive addition glasses. While slower driving would seem to reduce the likelihood of hitting nighttime road hazards, the authors reported a reduced ability to recognize road hazards among multifocal contact lens wearers.
The study also showed that multifocal contact lens wearers were able to see road signs, but at a much shorter distance than those wearing glasses, potentially decreasing the reaction time required for a driver to make necessary navigational decisions.
"For those patients who drive long distances and hours at night, practitioners should carefully consider the best form of correction of presbyopia for these patients," said author Byoung Sun Chu, PhD, formerly of the
The researchers conducted an experiment with 11 older adults between ages 45 and 64 years whose only experience with wearing lenses to correct problems with near vision was reading glasses. The study participants drove on a closed circuit driving track at night and performance was measured for road sign recognition, road hazard recognition and avoidance, lane keeping, near target recognition and distance to recognize standard street signs.
Dr. Chu points out that the relatively small sample size is likely to have led to an underestimation of some of the differences in driving performance between conditions, given that a number of the differences in driving performance almost reached statistical significance.
In addition to conducting studies with a larger sample size to confirm the findings, the author calls for studies to determine whether the outcomes found in this study for older adults with no experience wearing lenses to correct problems with near vision (other than reading glasses) will persist after adaptation to wearing the corrective lenses for a longer period of time.
"It is important that the results of this study are also used as a stimulus for improving the optical qualities of multifocal contact lenses to improve night time driving," added Dr. Chu.
Femto Cataract Laser Shows Improvement
Over Manual Surgery
A study in Science Translational Medicine (see below) showed that OptiMedica's Catalys Precision Laser System helped surgeons achieve significant im-provement in precision during several critical steps of cataract surgery compared to manual techniques.
"These study results clearly indicate that a femtosecond laser with integrated Optical Coherence Tomography imaging, advanced optics and control software can provide multiple benefits for cataract surgery," said the study's lead author Daniel Palanker, PhD, associate professor of Ophthalmology at Stanford University. Results of the clinical study, which compared 29 laser-treated eyes with 30 manually treated eyes, showed great improvement across these steps. Authors reported:
Femtosecond Laser-Assisted Cataract Surgery with Integrated Optical Coherence Tomography, Volume 2, Issue 58, November 17, 2010
