Oxford BioMedica acquires intellectual property rights for gene-based ocular products

Oxford BioMedica UK Ltd. (Oxford, U.K.) has entered into a license agreement with the Research Development Foundation, the technology transfer arm of the Clayton Foundation for Research (Houston), the company said in a press release.

The terms of the agreement give Oxford BioMedica exclusive rights to intellectual property that supports its gene-based ocular products RetinoStat and EncorStat. Oxford BioMedica will make an upfront payment and royalties on sales, the company said in the release.
The intellectual property details “a novel method for effective delivery of anti-angiogenic genes to the eye using lentiviral vectors,” the company said in the release.

Urgent assessment needed to avoid potential blindness

Suddenly seeing floaters or flashes of light may indicate a serious eye problem that—if untreated—could lead to blindness, a new study shows. The results found that one in seven patients with this symptom will have a retinal tear or detachment. “If we detect a tear and laser it, we can save people from potentially going blind,” said Sanjay Sharma, M.D., a professor of Ophthalmology and Epidemiology at Queen’s University and head of the Unit for Cost-Effective Ocular Health Policy at Hotel Dieu Hospital (Ontario, Canada). “But if fluid gets in under the retina and causes it to detach, it may be too late.” Because retinal tears can be extremely difficult to see, high-tech equipment and a thorough peripheral retinal examination are required to detect them, he adds.

Dr. Sharma and colleagues analyzed nearly 200 articles published in the peer-reviewed literature. After a meta-analysis of 17 articles, they noted that a retinal tear occurred in 14% of the cases of new onset floaters associated with an age-related change in the eye’s jelly. “If new floaters are associated with visual loss, a defect in the visual field, or the presence of blood or ‘tobacco dust’ in the eye jelly, the risk of retinal tear is significantly higher,” says Dr. Sharma. “Since retinal tear can lead to detachment in up to 50% of cases, new floaters and flashes is a medical condition that needs urgent assessment.” The results of the study were published in the Journal of the American Medical Association, is partially funded by the Canadian Institutes of Health Research.

Optical technique can identify early diagnosis

An early diagnosis of common ocular diseases can be determined via an optical technique that had never before been used for this purpose, researchers from the University of Granada said. The researchers studied the image quality in subjects affected by one of two pathologies, finding a greater amount of ocular aberrations and a higher level of scattering (term associated with the dispersion that light suffers when passing through the various ocular media) in affected eyes compared with results in healthy eyes.

Age-related macular degeneration (AMD) is the leading cause of central vision loss in developed countries, and mainly affects people over 50 years of age. As far as keratitis is concerned, this condition causes inflammation of the cornea and can cause blindness, due to the severe alterations that the corneal surface may suffer.

Carolina Herrera Ortiz and colleagues measured the image quality with two optical instruments and used a psychophysical test for assessing visual performance. Results from patients with AMD were compared with those obtained from a control group of similar age without any ocular pathology. Thus, the researchers could verify that for individuals affected by this condition there is an increased level of ocular scattering that could be mainly due to the disruption suffered by the light reflected in the damaged retina of the AMD eyes, because a priori optics are not expected to be altered, since it is a retinal pathology. The studies will be published in Cornea and Journal of Modern Optics.

Red reflex test to all newborns recommended

Physicians at The Vision Center of Children’s Hospital, Los Angeles, are strongly advocating a basic eye exam, including a red reflex test, be given to all children shortly after birth, the center said. Angela Buffenn, M.D., M.P.H., Director of the Orbit and Eye Movement Institute and Diana Dennis, M.A. of the Therapeutic Living Center for the Blind, reported on the problem of inadequate childhood vision screenings in Pediatric News. The red reflex test involves looking at the infant\’s eyes through an ophthalmoscope in a dimly lit room to see if there are any abnormalities in the back of the eye or white spots in the eyeball. The test is used to screen for abnormalities in the eye itself as well as ocular misalignment. If the red reflex is found to be abnormal, the child should be examined by a pediatric ophthalmologist in order to test for strabismus (crossed eyes), cataracts, glaucoma, retinoblastoma, retinal abnormalities, and high refractive errors. Oftentimes, the test is first administered by a pediatrician or family physician. The red reflex test has been endorsed as an important part of a well child visit by the American Academy of Pediatrics and the American Academy for Pediatric Ophthalmology and Strabismus.

“Too often we see children with developmental delay whose visual system has not been properly evaluated. Sometimes, parents also think that vision loss is less important than treating the seizure disorder or developmental disability, when the truth is we can address both at the same time,” said Dr. Buffenn.

Bepreve found effective for severe itching

Integrated results from two Phase III studies of bepotastine besilate ophthalmic solution 1.5% (Bepreve, Ista Pharmaceuticals, Irvine, Calif.) found the drug to be “as effective in suppressing ocular itching in patients with more severe itching as in patients with all grades of ocular itching,” the company said in a news release.

A total of 157 patients were enrolled in two 7-week, masked, randomized, placebo-controlled Conjunctival Allergen Challenge clinical studies (1 single site, 1 multi-site); 113 patients exhibited bilateral ocular itching grades greater than or equal to 3 at screening during study visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16 hours following instillation at study visits spaced 2 weeks apart during the enrollment period. The difference in mean itching grades (placebo-active) for the more severely affected subjects was within plus or minus 0.1 unit of the differences for the entire intent-to-treat (ITT) population, Ista said. The results were presented during the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology in Miami Beach, Fla. Bepreve was approved by the U.S. Food and Drug Administration in September 2009 for the treatment of ocular itching associated with allergic conjunctivitis. Bepotastine has been approved in Japan for systemic use in the treatment of allergic rhinitis since 2000 and urticaria/pruritus since 2002.

Steroids helpful for DME

For patients with diabetic macular edema (DME), intravitreal triamcinolone (IVTA) was able to improve vision in eyes that had continued to deteriorate despite receiving standard laser treatment, researchers at the University of Sydney, Australia, said in a university news item.  In the first three months after treatment, the patients initially treated with both IVTA and laser showed significantly better gains in vision than control group patients who were treated with laser only. After 2 years, patients in the original control group were also treated with IVTA. The beneficial effects persisted in most IVTA-treated patients throughout the 5-year study; however, 80% of patients in the initial IVTA group developed elevated intraocular pressure and 56% of them required therapy, the university said. Also, two-thirds of all patients required during the study period. Similar outcomes have been noted in other studies of steroid-based treatment and thus were not considered new safety concerns by the group.

Bausch & Lomb Introduces the Crystalens® Aspheric Optic (AO) Lens

Bausch & Lomb today announced that it is launching the Crystalens® AO, the first aberration-free accommodating intraocular lens (IOL) with aspheric optics to cataract surgeons worldwide.

Alcon to Enter Surgical Glaucoma Market by Acquiring Optonol

Acquisition reflects increasing importance of glaucoma surgery to preserve visionEntry into glaucoma surgery provides additional near term growth opportunity for AlconHUENENBERG, Switzerland, Dec 14, 2009 (BUSINESS WIRE) — Alcon
(NYSE:ACL)
announced today that it has entered into a definitive agreement to
acquire Optonol, Ltd., a medical device company that develops,
manufactures and markets novel miniature surgical implants used to lower
intraocular pressure (IOP) in patients with glaucoma. With this
acquisition, Alcon will acquire Optonol’s Ex-PRESS(TM) Mini Glaucoma Shunt.
This agreement will complement Alcon’s pharmaceutical produc…

Iluvien study shows promising early results

The 18-month results from the first human pharmacokinetic study (PK Study) of Iluvien in patients with diabetic macular edema has found the compound safe, licensee Alimera Sciences (Atlanta) said in a news release. Iluvien delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME). Formerly known as Medidur FA for DME, Iluvien is in fully recruited Phase III clinical trials, developer pSivida Corp. (Watertown, Mass.) said in a separate news release. Alimera’s 36-month, open-label, Phase II study, running concurrently with the pivotal Phase III FAME Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid FA, after administration of Iluvien in patients with DME.

There were a total of 37 patients enrolled in the PK study, 20 patients on the low dose of Iluvien (an approximate 0.23 μg per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45 μg per day dose). In the high dose group, 55% had at least a 10 letter improvement in best corrected visual acuity from baseline, and 36% achieved an improvement of 15 letters or greater. In the low-dose group, 23% had an improvement in BCVA of at least 10 letters from baseline, but none had an improvement of 15 letters or more. Intraocular pressure increases were not affected by the low dose version, but the high dose version yielded 29% with an IOP increase to 30 mm Hg or more. Iluvien is an extended release intravitreal insert designed to provide a sustained therapeutic effect of up to 36 months, for the low dose of Iluvien, and up to 24 months for the high dose of Iluvien. Iluvien is inserted into the patient’s eye with a 25-gauge needle, allowing for a self-sealing wound.

iSONEP well-tolerated in early studies

A Phase I clinical trial of iSONEP for the treatment of wet age-related macular degeneration found the compound met its primary endpoint of being well tolerated at dose levels ranging from 0.2 mg to 1.8 mg per intravitreal injection, developer Lpath (San Diego) said.
The preliminary study enrolled 15 patients with three patients in each dose level, Lpath said. Of the seven patients that had a baseline lesion that was considered “large,” four experienced a reduction exceeding 5 mm2 and three experienced a reduction of greater than 75%—with a single dose of iSONEP, the company said.

According to Lpath, of the two patients who were diagnosed with retinal pigment epithelial detachment in the Phase I study, both experienced complete or near-complete resolution of the condition—again, with only a single dose of iSONEP. iSONEP is the ocular formulation of a monoclonal antibody that targets sphingosine-1-phosphate (S1P), a bioactive lipid that is dysregulated in cancer and other disorders of inappropriate angiogenesis and inflammation. S1P promotes angiogenesis, inflammation, cell survival, and cell proliferation, all of which have been implicated in AMD.

Next Page »