Ophthalmology Product Guide

Study shows increased occurrence of dry eye in men aged 80 years or more

Jim Marino — Thu, 09 Jul 2009 03:45:41 +0000

A recent study conducted over 6,848 participants depicted that the occurrence of dry eye disease increased in men aged 80 years or more. High blood pressure, benign prostatic hyperplasia and the use of antidepressant raise the risk of the disease, the study conducted by Physicians’ Health Studies found. Dry eye is the “presence of clinically diagnosed dry eye” or symptoms that included severe dryness or irritability.

FDA approves Besivance for bacterial conjunctivitis

Jim Marino — Wed, 08 Jul 2009 18:18:45 +0000

The FDA has approved a new antibacterial eyedrop called Besivance for the treatment of a contagious eye infection called bacterial conjunctivitis, commonly known as “pinkeye.” Symptoms of bacterial conjunctivitis include red eyes, swelling, eyelids sticking together, itching, watering, and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis generally runs its course in seven to 14 days. Although this infection is common among kids, it can also affect people of other ages.

FDA Recommends Approval for Ophthalmic Product Enabled By InSite’s DuraSite® Technology

Jim Marino — Fri, 02 Jan 2009 12:14:32 +0000

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.

Akorn Announces FDA Approval Of Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%

Jim Marino — Thu, 18 Dec 2008 12:20:32 +0000

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.

Bausch & Lomb’s pink eye drug likely to get FDA recommendation

Jim Marino — Tue, 09 Dec 2008 07:08:51 +0000

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.

Experimental Drug RGN-259 Promotes Healing In Patients With Non-Healing Corneal Ulcers

Jim Marino — Tue, 02 Dec 2008 09:55:25 +0000

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.

Carl Zeiss Meditec announces new ophthalmology innovations that improve clinical efficiency

Jim Marino — Tue, 18 Nov 2008 15:07:50 +0000

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.

New ACE technology tracks eye rotation during LASIK

Jim Marino — Thu, 06 Nov 2008 08:58:56 +0000

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.

Special eye surgery lessens post-operative discomfort

Jim Marino — Fri, 31 Oct 2008 08:18:33 +0000

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.

FDA approves Hi-Tech Pharmacal’s generic ophthalmic solution

Jim Marino — Wed, 29 Oct 2008 12:54:20 +0000

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.