■ Othera drug: dry AMD data. Othera Pharmaceuticals had positive visual-function results from a phase 1/2 trial of OT-551 conducted at the National Eye Institute in patients with bilateral geographic atrophy. OT-551 is a topically dosed, small molecule that acts on oxidative stress and disease-induced inflammation. In the NEI trial, 10 subjects with advanced dry AMD in both eyes were enrolled.
All subjects received 0.45% OT-551 daily for 24 months in one eye, which was randomly chosen. The untreated fellow eye served as a control in the study. A statistically significant difference in favor of OT-551 was observed in the primary endpoint, mean change in BCVA, at the end of 24 months (mean change in BCVA for dosed eye of 13.3 letters gained vs. 7.6 letters lost for fellow eye control). No other meaningful differences between study eyes and fellow eyes were observed in other endpoints. In the NEI trial and in all studies of OT-551 to date, there have been no drug-related serious adverse events.
The absence of significant effect on the rate of GA lesion enlargement indicates the need for further study concerning the efficacy of OT-551 as a treatment for GA, said Wai T. Wong, MD, PhD, clinician-scientist, Retinal Diseases, at the NEI and principal investigator for the study.
■ B+L launches AR EDS 2 vitamins. B+L is introducing PreserVision Eye Vitamin and Mineral Supplement AREDS 2 formula. This builds on the original AREDS formula, replacing beta-carotene with lutein (10 mg) and zeaxanthin (2 mg) and adding omega-3 fatty acids (l000 mg) per daily dosage. Scientific studies show that the inclusion of high levels of omega-3 fatty acids, lutein, and zeaxanthin in the diet of at-risk individuals supports eye health and reduces the risk of being afflicted with AMD.
■ Oral drug in LCA trial. QLT Inc. has announced encouraging interim results from the first three subjects enrolled in a phase lb clinical proof-of-concept study of its orally administered drug for the treatment of Leber's congenital amaurosis (LCA). The drug, known as QLT091001 is a synthetic retinoid replacement for 11-cis-retinal, a key biochemical component of visual function.
The trial will evaluate the safety profile and effects on retinal function in eight pediatric subjects (age 5 to 14 years) diagnosed with LCA due to inherited deficiency of retinal pigment epithelium protein 65 (RPE65) or lecithin:retinol acyltransferase (LRAT). Based on positive results from the first two pediatric patients, an adult patient was added to the study. Subjects receive daily oral doses of QLT091001 for seven days at the Montreal Children's Hospital at the McGill University Health Centre.
After seven days of treatment, all of the subjects experienced clinically relevant improvements in one or more visual function parameters, including BCVA, Goldmann visual field, and/or retinal sensitivity as measured by full-field sensitivity threshold testing, reports QLT. Subjects have also reported improvement in visual performance related to daily living. The onset of visual changes was rapid and there was progressive improvement beyond the seven days of treatment, with some effects persisting for up to four months after treatment.
■ Alimera Sciences goes public. Alimera Sciences, which specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, issued publicly traded stock in April. The offering was priced at $11 a share and trades under the NASDAQ symbol ALIM.
Alimera is currently focused on retinal diseases, with its sustained-release implant lluvien for DME in late-stage clinical trials.
■ Iridex buys RetinaLabs product lines. Iridex said it has acquired certain assets from RetinaLabs, Inc., a privately held company based in Atlanta. RetinaLabs develops and markets retinal instrumentation and consumables used to perform vitreo-retinal procedures in the operating room and in surgery centers.
■ Topcon in new headquarters. Topcon Medical Systems, which makes retinal cameras, OCT instrumentation, and other devices used by retinal specialists, has relocated its US corporate headquarters from Paramus, NJ, to 111 Bauer Drive, Oakland, NJ 07436.
The company said the relocation, in line with strong business growth and development, necessitated the shift to a more spacious building. The company says the new, modern facility will enable Topcon to further broaden its infrastructure, streamline business operations and consistently deliver innovative solutions within the ophthalmic industry.
A green-sensitive office building, Topcon's new corporate head office is equipped with eco-friendly and energy-efficient features, including recycled materials, low voltage lighting, and sensors. The company's phone and fax numbers, and Web address will remain the same: Phone:_20l-599-5l00, Fax: 201-599-5248, Web: www.topconmedical.com.
■ Luveniq granted priority review. Lux Biosciences, Inc. says it has been given priority review status by the FDA for its investigational drug Luveniq (LX211) oral voclosporin for the treatment of noninfectious uveitis involving the intermediate or posterior segment of the eye. The FDA had previously fast-tracked the drug.
■ Anti-VEGF for DME. The much-awaited results of a major government-sponsored study show that treating DME with ranibizumab, plus laser treatment if needed, appears to result in better vision than laser treatment alone. The data, released by the Diabetic Retinopathy Clinical Research (DRCR) Network, was published in Ophthalmology online, the journal of the American Academy of Ophthalmology.
DRCR Network investigators studied 854 eyes (691 participants) at 52 clinical centers across the US, and compared four treatment modalities: ranibizumab plus prompt laser treatment, ranibizumab plus deferred laser treatment (provided at 24 weeks or later, if indicated), a corticosteroid (triamcinolone) eye injection plus prompt laser treatment, or prompt laser treatment alone.
At the one year follow-up, patients who had received ranibizumab with prompt or deferred laser treatment had, on average, significantly better visual acuity than the group treated with laser alone. Also, significantly more patients in the ranibizumab-treated groups gained vision and fewer suffered vision loss.
At the one year follow-up, nearly 50% of study patients who received the new combined treatment had substantial improvement in vision, compared with 28% who received laser treatment alone.
“The results appear to be applicable to most people who have DME in the center of the macula with some vision loss, whether the person has Type 1 or Type 2 diabetes, is old or young, or is a woman or a man,” said Neil M. Bressler, MD, of Wilmer Eye Institute, the chair of the nationwide DRCR Network.
■ Alcon to sell Synergetics products. Alcon will pay Synergetics $32 million for the right to market a range of Synergetics' ophthalmic products and to settle all litigation between the two companies.
Synergetics products used in vitreoretinal surgery include light sources, surgical instruments, lasers and laser probes. The company manufactures both disposable and reusable instruments for vitreoretinal surgery.
■ Iridex introduces new laser. Iridex Corporation has begun shipping its new IQ 532 laser systems. The IQ 532 is a high-power, 532 nm, dual port multipurpose laser system for use in treating such sight-threatening eye diseases as diabetic retinopathy, AMD, and glaucoma.
“The time and effort we invested to perfect our core system platform and obtain regulatory approval for a family of laser products has made it possible to introduce the IQ 532 green laser within one year of shipping the IQ 577 yellow laser,” commented Theodore A. Boutacoff, president and CEO of Iridex. “Continuing with this platform approach, we look forward to the timely introduction of additional systems currently under development.”
As with the IQ 577, the IQ 532 features dual-port laser output as well as a graphic, touchscreen interface. Dual-port connectivity provides the physician with added convenience and efficiency by permitting the exchange of multiple delivery devices with one-touch speed and simplicity. Iridex says setup and use of the IQ 532 system for surgery is easy and intuitive, thanks to its ergonomic design and user interface.
■ Eye radiotherapy granted CE mark. Oraya Therapeutics, Inc. said it has been awarded the CE mark for its stereotactic radiotherapy system that delivers low-energy X-rays for the treatment of wet AMD.
The one-time radiation treatment is given in conjunction with an anti-VEGF drug regimen, and with the expectation that visual acuity outcomes for the treated patients will be maintained with significantly less frequent drug injections as compared to the sham control group. About 150 patients from up to 10 sites will participate in a second European trial with approximately one-third of those subjects receiving a sham exposure and the remainder receiving a radiation dose of either 16 or 24 Gy.
In an earlier study of the device, more than 60 patients were treated and subsequently monitored, with the earliest patients now approaching 18 months since treatment. Oraya says results from that study have shown the potential for meaningful visual outcome improvements as well as a substantive reduction in the required drug regimen.
■ Stem cells to treat Stargardt's. Advanced Cell Technology has been granted orphan drug status by the FDA for its human trial employing embryonic stem cells to treat Stargardt's Disease.
The 12-patient phase 1/2 study uses stem cells to recreate RPE that support the photoreceptors needed for vision. These cells are often the first to die off in Stargardt's Disease and AMD, which in turn leads to loss of vision. RP