Ophthalmology Product Guide » cataract surgery

Icon Bioscience Initiates Phase 2/3 Pivotal Clinical Study Of Novel Ophthalmic Drug Candidate

Jim Marino — Fri, 08 Jan 2010 12:37:01 +0000

Icon Bioscience, Inc. has announced that it has initiated its Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090 in patients undergoing cataract surgery. IBI-10090 is a novel anti-inflammatory drug product, based on IBI’s proprietary Verisome(TM) drug delivery platform technology, administered as a single injection into the anterior chamber of the eye that is designed to last approximately two to three weeks.

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Multicenter Study Finds AMD Patients Benefit from Cataract Surgery

Jim Marino — Thu, 03 Dec 2009 11:26:59 +0000

Cataract surgery improved vision in patients with any stage–from mild to advanced– AMD in the first study to include an adequate number of advanced AMD patients. Data was obtained from the multicenter, prospective Age-Related Eye Disease Study (AREDS), funded by the National Eye Institute (NEI), which was organized primarily to evaluate the effects of high-dose vitamin and mineral supplements on cataract and AMD.

Six-Month Neuroadaptation Period Found for Tecnis Multifocal IOL

Jim Marino — Thu, 26 Nov 2009 15:19:06 +0000

Abbott Medical Optics conducted a 250-eye study of the Tecnis multifocal intraocular lens (IOL) and measured results at three days, 30 days, 90 days, 150 days and 210 days after cataract surgery. Most of the study participants achieved their best vision after 180 days, which the researchers called a neuroadaptation period. During the last checkup, 96.8 percent of eyes could read at 20/20 (J2) without correction, with 83.2 percent reading at 20/15 (J1).

ISTA planning on FDA approval for bromfenac label change

Jim Marino — Thu, 10 Sep 2009 04:42:16 +0000

ISTA Pharmaceuticals is planning to ask the FDA to approve a change to the label of its bromfenac 0.09% ophthalmic solution. It has obtaining positive preliminary phase III results in a confirmatory clinical study of once-daily bromfenac (Xibrom QD) for the treatment of inflammation and pain after cataract surgery. The topical non-steroidal anti-inflammatory compound currently is labeled for twice-daily use beginning 24 hours after such surgeries.

Study indicates Avastin can improve loss of vision

Jim Marino — Thu, 06 Aug 2009 11:33:34 +0000

Researchers have found that the cancer drug bevacizumab medication (sold as Avastin) may prove useful in improving vision loss in diabetic patients, as well as in those who have undergone cataract surgery. Diabetic retinopathy (DR) is the major threat to vision in working-age people. While laser treatment is usually able to reduce vision loss, widespread, diffuse DME (DDME) is often resistant to laser and other standard treatments.

Acuvail receives FDA approval

Jim Marino — Thu, 30 Jul 2009 04:41:56 +0000

Allergan Inc has received the FDA approval for its post-cataract surgery eye solution Acuvail (ketorolac tromethamine ophthalmic solution). The eye solution is aimed at treating pain and inflammation following cataract surgery. Allergan said that more than 3 million cataract surgeries are performed in the US every year. Acuvail is expected to reach the market in September.

FDA nod to Akorn’s Akten™ Ophthalmic Gel 3.5%

Jim Marino — Fri, 10 Oct 2008 10:59:25 +0000

The U.S, Food and Drug Administration has approved Akorn, Inc.’s Akten™ Ophthalmic Gel 3.5%, the first approval to an ocular anesthetic in the last 40 years. The preservative free product is stored at room temperature and can be used in any ocular applications such as cataract surgery, Lasik surgery and refractive surgery that need a topical anesthetic. This is the company’s first NDA drug product developed internally.