Posted by Jim Marino on January 2, 2009
InSite Vision Incorporated has announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision’s DuraSite® patented drug delivery system. DuraSite is a synthetic polymer of cross-linked polyacrylic acid that stabilizes small molecules in an aqueous matrix, allowing for targeted and sustained administration. DuraSite enables a less frequent dosing schedule, increased patient compliance, and increased efficacy.
Posted by Jim Marino on December 18, 2008
Akorn, Inc. has announced that the U.S. Food and Drug Administration has granted approval for Akorn’s Abbreviated New Drug Application (ANDA) for Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%. Ciprofloxacin HCl Ophthalmic Solution is indicated for the treatment of infections caused by microorganisms in corneal ulcers and conjunctivitis. Annual sales for Ciprofloxacin HCl Ophthalmic Solution are approximately $20 million, according to IMS sales data. Akorn expects to launch Ciprofloxacin in 2009. Of the 20 product approvals received in 2008, 8 were launched in 2008 and 10 are scheduled for launch in the first half of 2009.
Posted by Jim Marino on December 9, 2008
Bausch & Lomb has announced that its pink eye drug besifloxacin is currently is likely to get recommended by the FDA. Its Dermatologic and Ophthalmic Drugs Advisory Committee voted to recommend approval for besifloxacin 0.6. The drug is required for treatment of bacterial conjunctivitis. Bausch & Lomb plans to start marketing besifloxacin in the U.S. in 2009, pending FDA approval. It can be added that Conjunctivitis is an inflammation of the conjunctiva most commonly due to an allergic reaction or an infection.
Posted by Jim Marino on December 2, 2008
Regenerx Biopharmaceuticals, Inc. has announced that its ophthalmic drug candidate, RGN-259, was used to treat four neurotrophic keratitis patients with non-healing eye ulcers caused primarily by the herpes zoster virus under a “Compassionate Use” IND (Investigational New Drug application). RGN-259 is a sterile eye drop formulation of Tβ4 being developed by RegeneRx for use in treating ophthalmic wounds and related disorders. In all four patients, the eye ulcers either completely healed or demonstrated significant improvement by treatment day 28, the maximum treatment period allowed under the clinical protocol.
Posted by Jim Marino on November 18, 2008
Carl Zeiss Meditec has announced the newest innovations OPMI Lumera® i Surgical Microscope and VISULAS Trion™ Combi System. These new systems include diagnostic and surgical applications covering the entire spectrum of patient care and supporting all major segments of ophthalmology, including cataract/refractive, retina and glaucoma. These innovations are designed to provide the clinician with better diagnostic and treatment options while streamlining efficiency in the practice. OPMI Lumera® i Surgical Microscope includes a touch-screen control panel, integrated camera control and an ergonomic foot pedal whereas VISULAS Trion™ Combi System is world’s first multi-color photocoagulator.
Posted by Jim Marino on November 6, 2008
A novel technology called Zyoptix Advanced Control Eyetracking (ACE) can emerge as an effective treatment for the treatment of astigmatism and severe myopia. The innovative technique has the ability to track eyeball’s rotation during a laser eye surgery. Earlier, eye rotation during surgery influenced the predictability of surgical outcomes. That is why doctors discouraged patients of short-sightedness and astigmatism from going for LASIK. Designed to advance the patient safety, ACE also adjusts the laser ablation pattern for the duration of the laser surgery.
Posted by Jim Marino on October 31, 2008
A new surgery known as sutureless eye surgery has helped carry out around 80 successful operations. It heals wounds much faster than through conventional procedures. The specialty of the surgery is the use of exceptionally smaller and disposable instruments that are inserted into the eye of the patient with the use of a tiny cannula. When it is removed from the eye, the wound is much smaller and less painful. The procedure also takes lesser time. The surgery is being carried out at Bristol Eye Hospital.
Posted by Jim Marino on October 29, 2008
The U.S. Food and Drug Administration has given the final approval to Hi-Tech Pharmacal Company’s dorzolamide and timolol ophthalmic solution, the generic for Merck’s Cosopt®. Indicated for lessening elevated intraocular pressure in patients suffering from ocular hypertension or open-angle glaucoma, the generic solution will be launched in the markets soon. Hi-Tech Pharmacal Co. Inc. specializes in manufacturing semi-solid and liquid dosage forms of sterile ophthalmic and inhalation products.
Posted by Jim Marino on October 29, 2008
Scientists from the Moorfields Eye Hospital have invented a technology, Motion Displacement Test that will reduce the time taken for the detection of glaucoma. The novel technology is designed to catch one of the first symptoms of glaucoma, that is, the ability of the patient to spot speedy movement. The test is taken on a computer. The patient is asked to look at a dot in the centre which is surrounded by a number of white lines with a grey background. They are required to click a mouse when they notice a white line moving. Failure in spotting such movement indicates that they suffer from glaucoma.
Posted by Jim Marino on October 23, 2008
Researchers from the University of Texas Southwestern Medical Center (Dallas) have reported that long-term anti-retroviral therapy (ART) used for the treatment of HIV-1 infection can cause ptosis and external ophthalmoplegia (progressive paralysis of the extraocular muscles. Thus, the authors of the study have recommended that clinicians should be aware of potential adverse effects of the treatment such as myopathic complications, weakness, neuropathy, deafness etc.
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