Ranibizumab fast-track designation denied; Genentech plans to file complete application
October 1st 2005South San Francisco—Genentech Inc. said it intends to file a complete Biologics License Application (BLA) in December for its ranibizumab (Lucentis) treatment for the wet form of age-related macular degeneration (AMD). In addition, the company said it was recently notified that the FDA denied a request for fast-track designation for the investigational drug, which would allow for a rolling BLA submission.
Ranibizumab injections after PDT beneficial, interim trial finds
October 1st 2005Montr?al—The addition of intravitreal ranibizumab (Lucentis, Genentech) has been associated with impressive efficacy for improving and stabilizing vision and reducing the need for repeat photodynamic therapy (PDT) after 12 months of follow-up in the FOCUS (RhuFab V2 Ocular Treatment Combining the Use of Visudyne to Evaluate Safety) trial, said Jeffrey S. Heier, MD, at the annual meeting of the American Society of Retina Specialists.
Merger of OSI, Eyetech solidifies research
October 1st 2005New York—The $935 million acquisition of Eyetech Pharmaceuticals Inc. by OSI Pharmaceuticals Inc. will boost research and development (R&D) opportunities for both companies, while preserving Eyetech's integrity as a stand-alone business unit, according to leaders of both organizations.
NTG treatment plan similar to POAG management
September 19th 2005San Francisco - Results from the Collaborative Normal Tension Glaucoma Study provided the first and still best evidence that lowering IOP by 30% in patients with normal-tension glaucoma (NTG) does prevent or slow the progression of glaucomatous visual field loss, said Donald L. Budenz, MD, MPH, associate professor, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami.
Defining the role of neuroimaging in normal-tension glaucoma
September 19th 2005San Francisco - Debate continues over whether to perform neuroimaging in patients with typical normal-tension glaucoma (NTG), but there are warning signs that should prompt ordering magnetic resonance imaging (MRI) with gadolinium, said Christopher A. Girkin, MD, MPH, associate professor of ophthalmology and director, glaucoma service, Callahan Eye Foundation Hospital, University of Alabama at Birmingham.
NTG patient evaluation based on ruling out nonglaucomatous etiologies
September 19th 2005San Francisco - The diagnosis of normal-tension glaucoma (NTG) should be approached as one of exclusion with careful evaluation of the patient for other etiologies that may underlie observed structure and function changes, said Andrew G. Iwach, MD, associate clinical professor of ophthalmology, University of California, San Francisco.
IOP-based patient stratification has value; NTG or POAG debate continues
September 19th 2005San Francisco - Normal-tension glaucoma (NTG) is likely primary open-angle glaucoma (POAG) with a lower baseline IOP. However, it is probably worthwhile to continue to draw a distinction between these two entities because it provides an opportunity for identifying risk factors that may have varying influence depending on the level of IOP, said Anne L. Coleman, MD, PhD, the Frances and Ray Stark Professor of Ophthalmology, Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles.
New observations noted about circadian IOP patterns
September 19th 2005San Francisco - Both IOP and the rate of aqueous flow follow a circadian rhythm and that has significant implications for the evaluation and treatment of patients with ocular hypertension and glaucoma, said Robert N. Weinreb, MD, director, Hamilton Glaucoma Center, and distinguished professor of ophthalmology, University of California, San Diego.
Compliance and persistency foundation for effective therapy
September 19th 2005San Francisco - Compliance and persistency with IOP-lowering medications are difficult to assess but important to address because they affect treatment results, said Donald L. Budenz, MD, MPH, associate professor, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami.
Two bottle limit defines optimal medical therapy
September 19th 2005San Francisco - Optimal medical therapy for most patients needing IOP-lowering treatment may be as simple as one or two bottles, said Robert D. Fechtner, MD, professor of ophthalmology, director, glaucoma division, Institute of Ophthalmology and Visual Science, New Jersey Medical School, University of Medicine and Dentistry of New Jersey, Newark.
Beta-blockers not obsolete, but no longer treatment of choice for first-line therapy
September 19th 2005San Francisco - Based on a review of efficacy, safety, and compliance issues, Shan C. Lin, MD, now considers a prostaglandin analogue as his drug of first choice for medical treatment of ocular hypertension and glaucoma. For select patients, however, beta-blockers may still be appropriate if the cosmetic side effects of the prostaglandin analogues or their cost present significant obstacles to use.
Pros of early diagnosis outweigh cons
September 19th 2005San Francisco - Early diagnosis of glaucoma does matter because it offers an opportunity to alter the significant morbidity associated with this disease, said Kuldev Singh, MD, MPH, professor of ophthalmology, director, glaucoma service, Stanford University, Stanford, CA.
Experience with cardiovascular risk model offers useful lessons
September 19th 2005San Francisco - Many parallels can be drawn between glaucoma and coronary heart disease - both are chronic diseases that can be depicted on a continuum of progression from disease that is first undetectable, then asymptomatic, and ultimately results in functional impairment - and both are associated with a modifiable causal risk factor (IOP and serum cholesterol) that when treated effectively results in a reduction in disease progression risk.
More sensitive tests aim to detect glaucoma-related function and structure changes
September 19th 2005San Francisco - Developers of specialized perimetric tests and quantitative optic nerve and retinal nerve fiber layer (RNFL) analyzers have introduced hardware and software modifications to improve those new tools for assessing function and structure in patients with glaucoma. However, their roles in clinical practice still await definition pending further study, said Christopher A. Girkin, MD, MPH, associate professor of ophthalmology and director, glaucoma service, Callahan Eye Foundation Hospital, University of Alabama at Birmingham.
First glaucoma risk calculator set to debut
September 19th 2005San Francisco - A newly developed risk calculator will make therapeutic decision-making for patients with ocular hypertension a little more straightforward, said Robert N. Weinreb, MD, director, Hamilton Glaucoma Center, and distinguished professor of ophthalmology, University of California, San Diego.
Epidemiology studies highlight glaucoma public health impact
September 19th 2005San Francisco - Statistics released by the World Health Organization (WHO) in 2002 indicate glaucoma has become a more common cause of blindness than it was in the past, said Anne L. Coleman, MD, PhD, the Frances and Ray Stark Professor of Ophthalmology, Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles.
Experts highlight latest advances, care at Glaucoma 2005
September 19th 2005San Francisco - A panel of glaucoma experts from across the United States highlighted the latest advances in understanding glaucoma and caring for these patients at “Glaucoma 2005: Mastering Tools and Techniques for the 21st Century,” on Saturday, Sept. 17, at the Ritz-Carlton San Francisco. Now in its 5th year, the program included lectures, panel discussions, and a mini-symposium covering a variety of glaucoma issues with a distinguished faculty.
Glaucoma treatment costs present economic ramifications
September 15th 2005Fort Lauderdale, FL—The economic ramifications of treating ocular hypertension and glaucoma bring some serious questions into the spotlight, notably the costs of treatment and especially the increased rate of cataract extractions associated with the use of anti-glaucoma eye drops. Harry Quigley, MD, considered these issues at the annual meeting of the Association for Research in Vision and Ophthalmology.
Photoscreening efforts for preschoolers need guidance
September 15th 2005Orlando—A review of 17 volunteer-led preschool photoscreening programs indicates that such programs can be highly successful but that strong, preferably paid, administrative leadership is crucial in ensuring adequate rates of follow-up and referral, according to Sean P. Donahue, MD, PhD, associate professor of ophthalmology and visual sciences, pediatrics, and neurology at Vanderbilt University Medical Center, Nashville, TN, and chief of ophthalmology, Monroe Carell Jr. Children's Hospital at Vanderbilt.
Glaucoma treatment costs present economic ramifications
September 15th 2005Fort Lauderdale, FL—The economic ramifications of treating ocular hypertension and glaucoma bring some serious questions into the spotlight, notably the costs of treatment and especially the increased rate of cataract extractions associated with the use of anti-glaucoma eye drops. Harry Quigley, MD, considered these issues at the annual meeting of the Association for Research in Vision and Ophthalmology.
Varying lens power profiles appear to be visually inconsequential
September 15th 2005Sydney, Australia—Currently available soft contact lenses vary substantially in their optic zone refractive power distribution, and labeled lens power may not correspond exactly to the effective power of the lens on the eye. However, with attention to proper lens fitting, the power profile differences do not appear to result in measurable differences on short-term visual performance, according to the results of a study undertaken by Australian researchers.
Photoscreening efforts for preschoolers need guidance
September 15th 2005Orlando—A review of 17 volunteer-led preschool photoscreening programs indicates that such programs can be highly successful but that strong, preferably paid, administrative leadership is crucial in ensuring adequate rates of follow-up and referral, according to Sean P. Donahue, MD, PhD, associate professor of ophthalmology and visual sciences, pediatrics, and neurology at Vanderbilt University Medical Center, Nashville, TN, and chief of ophthalmology, Monroe Carell Jr. Children's Hospital at Vanderbilt.