Alcon announced that it purchased the
This product is currently in clinical development to treat dry eye and other ocular surface diseases.
"The acquisition of these products from Sirion is part of our business development strategy to gain access to late-stage or approved products that will incrementally add to sales in the near-term, while also building our long-term pipeline," said Kevin Buehler, Alcon's president and chief executive officer.
The closing of this agreement is expected to occur by the end of the first quarter of 2010 and is contingent upon customary closing conditions and required regulatory approvals.
Oraya Will Study Radiation Therapy For Wet AMD
Oraya Therapeutics reports that enrollment is under way for the first- ever masked and sham-controlled study to demonstrate the efficacy and safety of radiation therapy for the treatment of wet age-related macular degeneration. The trial is being conducted at seven European sites, and will include a minimum of 150 patients, with approximately one-third of those receiving a sham exposure and the remainder receiving radiation dosing of either 16 or 24 Gray (GY).
All patients will have standard of care anti-VEGF drug therapy, and the trial is designed and powered to measure the effect of the radiation adjunct on vision outcomes and on the frequency of anti-VEGF injections. Trial endpoints will be evaluated one year post radiation treatment. The radiation dose is delivered using Oraya's IRay system, a proprietary, non-invasive, low-energy stereotactic X-ray platform that has been in development since 2007. More than 60 patients have been treated in a Phase I study of the device; results from that study led to the design and initiation of the new trial.
The IRay system is an investigational radiosurgical device designed specifically to treat diseases of the eye. The system uses a vacuum-coupled contact lens interface, the I-Guide, which holds the eye to maintain stability during treatment, while detecting eye motion. Because the radiation delivered is low-voltage, comparable to a chest or dental X-ray, the IRay is suitable for use in a typical ophthalmology office setting. The entire patient treatment process requires only a topical anesthetic, and lasts 15 to 20 minutes.
Information on the study can be found at orayainc.com/clinicaltrials.asp, and by searching clinicaltrials.gov for identifier NCT01016873.
Inspire Dry-Eye Product Misses Trial Endpoints
Inspire Pharmaceuticals an-nounced that its Phase III clinical trial of Prolacria (diquafosol tetraso-dium ophthalmic solution) 2% for the treatment of dry-eye disease did not meet its primary or secondary endpoints. "We have provided the top-line results from this trial to our partner Allergan and we will be conducting a thorough review of the program before determining next steps, if any," said Christy L. Shaffer, PhD, president and CEO of Inspire.
The six-week, randomized, pla-cebo-controlled trial included 490 pa-tients who had a fluorescein staining score of three in the central region of the cornea at baseline, using the National Eye Institute scale of zero to three. The primary endpoint was the proportion of subjects receiving Prolacria, administered four times daily as eye drops, that achieved clearing, or a staining score of zero, in the central region of the cornea in the study eye at the six-week trial endpoint, compared to those receiving placebo. The secondary endpoint was the proportion of patients receiving Prolacria that achieved greater than or equal to a two-unit reduction in staining scores at the six-week trial endpoint, compared to those receiving placebo.
Studies Assess Smoking in Glaucoma, Uveitis
A pair of studies offer new incentive for patients with eye disease to quit smoking. First, research at several sites in
The study involved 120 women diagnosed with POAG and scheduled for trabeculectomy, distributed into three groups: 40 smokers; 40 ex-smokers; and 40 non-smokers. Aqueous humor and plasma samplers were obtained from each subject at the beginning of the surgical procedure. Both inflammation and apoptosis processes were studied by enzyme immunoassay and Western blot procedures respectively. We analyzed the interleukin-6 (IL-6) levels as an inflammation marker and the expression of caspase-3 and poly (ADP-ribose) polymerase 1 (PARP-1) as apoptosis markers. Their results showed that IL-6, caspase-3 and PARP-1 levels were significantly higher in the women who smoked than in the ex-smoker and non-smoker glaucomatous groups (p<0.05).
The same team is currently undertaking a project to attempt to evaluate whether smoking influences the expression of the same molecules in men with glaucoma.
Smoking may also contribute to ocular inflammation in patients with uveitis, according to another study, this one at the Proctor Foundation,
The odds of a smoker having ocular inflammation were 2.2-fold that of a patient who had never smoked (p<0.001). All anatomic subtypes of uveitis were associated with a positive smoking history, with odds ratios (ORs) of 1.7, (p=0.002) for anterior uveitis, 2.7 (p=0.005) for intermediate uveitis, 3.2 (p=0.014) for posterior uveitis, and 3.9 (p<0.001) for panuveitis. In patients with panuveitis and cytoid macular edema, the OR was 8.0 (p<0.001) compared with 3.1 (p<0.001) for patients without CME. Patients with intermediate uveitis and CME also had a higher OR (OR 8.4, p=0.001) compared with patients without CME (OR 1.5, p=0.342). Patients with a smoking history were at greater odds of having infectious uveitis (OR 4.5, p<0.001) than noninfectious uveitis (OR 2.1, p<0.001), although both were associated with smoking.
Immune Cell Linked to Scarring in Graves' Disease
Fibrocytes, which cause significant scar-ring in lung disease, appear to have a similar effect in Graves' disease. Fibrocytes are present at a higher than normal fre-quency in patients with Graves' disease, according to a new study, the first to associate fibrocytes with this autoimmune disease.
The discovery is a major step forward in explaining how and why the orbit of the eye is subject to scarring and inflammation in Graves' disease. The findings may also lead to new strategies to target scarring or fibrosis, say authors Raymond S. Douglas, MD, PhD, and Terry J. Smith, MD, at the University of Michigan Kellogg Eye Center. The study appears in January's Journal of Clinical Endocrinology & Metabolism.
Up to half of those affected will develop inflammation or fibrosis around their eyes, creating the bulging appearance associated with
Fibrocytes, immune cells derived from bone marrow that circulate through the bloodstream, can infiltrate tissue, generating excess connective tissue and areas of fibrosis, for example, following pulmonary or kidney injury.
The investigators and their colleagues compared tissue samples from 70 patients with the disease and 25 healthy subjects. Fibrocytes were present at substantially higher frequencies—as much as five times greater—in patients with Graves' disease. These levels were observed in both the bloodstream and in the orbital tissues of patients who had developed thyroid eye disease.
In earlier studies, Drs. Smith and Douglas identified the antigens that trigger the overactive immune response in
"We now have a much clearer picture of the disease process, including the pathway by which fibrocytes reach the orbit," says Dr. Douglas. "Drugs currently under development for other fibrotic diseases are designed to disrupt this pathway and prevent fibrocytes from reaching their target." According to Dr. Douglas, "These therapies may be just as effective for our patients with thyroid eye disease."
J Clin Endocrinol Metab. 2010 Jan;95(1):62-5.
UV-Blocking Contact Lenses Can Protect Eyes
A new study reported in Investigative Ophthalmology & Visual Science found that UV-blocking contact lenses can reduce or eliminate the effects of the sun's harmful UV radiation. Author Heather Chandler, PhD, from
"Not all contact lenses offer UV protection, and, of those that do, not all provide similar absorption levels," Dr. Chandler said. "This research will help patients and doctors consider appropriate UV-blocking contact lenses for those who need vision correction, to fill in some of the UV blocking gaps left by more traditional means. The data generated from this study could support the use of UV-absorbing contact lenses and greatly impact the health of a large number of people."
Investigative Ophthalmology and Visual Science. 2010;51:172-178