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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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.

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 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.

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.

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.