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New Medidur study begins

Alimera Sciences and pSivida have announced that enrolment has begun for the first human pharmacokinetic study of fluocinolone acetonide (FA) in Medidur, the companies' product for the treatment of diabetic macular oedema (DME).

Ophthotech Corporation has announced deals with two companies to obtain the rights to treatments for age-related macular degeneration (AMD).

The decline in quality of life (Qol) and the increased need for daily living assistance in patients with wet age-related macular degeneration (AMD) substantiates the need for new treatments that can halt disease progression, according to a multi-country study published in the September issue of Archives of Ophthalmology.

Intravitreal injections for the treatment of retinal diseases, such as neovascular age-related macular degeneration (AMD), could be replaced by a non-invasive gel formulation, applied under the eyelid, according to a presentation made at this month's meeting of the British Royal Pharmaceutical Society in Manchester, UK.

TareGen has initiated a multicentre Phase II clinical trial for the topically applied TG100801 in patients with age-related macular degeneration (AMD).

Opko Health has initiated the Phase III COBALT (Combining Bevasiranib And Lucentis Therapy) clinical trial of bevasiranib for the treatment of wet age-related macular degeneration (AMD).

Regeneron Pharmaceuticals and Bayer HealthCare have initiated a Phase III study of the VEGF Trap-Eye for the treatment of wet age-related macular degeneration (AMD).

The National Institute for health and Clinical Excellence (NICE) in England is to delay issuing guidance on Lucentis and Macugen after an unprecedented patient outcry over its decision to block access to them.

C3 gene linked to AMD

The gene, complement C3, has been identified as playing an important role in the pathogenesis of age-related macular degeneration.

Results from Phase II continuation studies of pegaptanib sodium (Macugen) for the treatment of diabetic retinopathy (DR) and Central Retinal Vein Occlusion (CRVO), found that the relative benefits of the treatment were maintained throughout the continuation period with no new safety signals to report.

A potential new treatment approach for retinopathy of prematurity (ROP) may be possible now that insulin-like growth factor binding protein 3 (IGFBP-3) has been found to play an important role in promoting the development of retinal blood vessels.

Researchers from University College London (UCL), Moorfields Eye Hospital and the University of Sheffield, UK are launching a pioneering project that plans to use stem cells to cure blindness resulting from age-related macular degeneration.

Fluorescein angiography (FA) remains a valuable tool for monitoring anti-VEGF drugs after intravitreal injections, however, optical coherence tomography (OCT) is becoming and increasingly popular method.

Intravitreal injection of up to 4 mg of a fusion protein that is an anti-vascular endothelial growth factor agent (VEGF Trap-Eye, Regeneron Pharmaceuticals Inc.) is well tolerated and yields no evidence of ocular inflammation. The agent appears to produce rapid and durable clinical increases in best-corrected visual acuity, along with improvements in anatomic features, in patients with neovascular (wet) age-related macular degeneration.

Interim results of a study of pegaptanib sodium as maintenance therapy for age-related macular degeneration show that patients previously treated successfully with other agents maintain visual and anatomic stability.

The National Institute for Health and Clinical Excellence (NICE) in England produced its first Appraisal Consultation Document (ACD) regarding the use of anti-vascular endothelial growth factor (anti-VEGF) drugs for the treatment of wet age-related macular degeneration (AMD) recently. Essentially, the document recommended that the new anti-VEGF inhibitor Lucentis (ranibizumab; Novartis Ophthalmics) may be used only to treat predominantly classic subfoveal choroidal neovascularization (CNV) which shows evidence of progression in the second affected eye, provided the visual acuity is between 6/12 and 6/96.1 After considering feedback from formal consultees, the Appraisal Committee will prepare a Final Assessment Document (FAD) for submission to NICE who will then issue guidance.

Ninety percent achieved the efficacy endpoint, and, furthermore, over two-thirds of patients improved by at least three lines and one-quarter improved by at least five lines in distance vision

QLT has announced that the Committee for Medicinal Products for Human Use (CHMP) will recommend to the European Commission that the occult indication for Visudyne be removed from the product's European label.

Neurotech Pharmaceuticals has begun enrolment for two Phase II/III clinical trials of NT-501; it's lead Encapsulated Cell Technology (ECT) product for the treatment for retinitis pigmentosa (RP).

Alimera Sciences has announced that enrolment for its Phase III global clinical trial, FAME (Fluocinolone Acetonide in Diabetic Macular Edema), has exceeded 50%.

CoMentis (formerly Athenagen) has initiated a Phase II trial of ATG3, a topical eye drop therapy for the treatment of neovascular age-related macular degeneration (AMD).

Optical coherence tomography (OCT) is a useful tool for determining when re-treatments with ranibizumab are required in patients with neovascular age-related macular degeneration (AMD).

Optical coherence tomography (OCT) is an effective screening tool for wet age-related macular degeneration (AMD).