FDA approves Omidria 

Omidria (phenylephrine and ketorolac injection) 1%/0.3% is the only Food and Drug Administration-approved product for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain, developer Omeros (Seattle) said in a news release.

In pivotal trials, Omidria demonstrated statistically significant and clinically meaningful improvement in the prevention of miosis and reduction of postoperative pain relative to placebo. Ocular adverse reactions in the clinical trials were similar between the Omidria and placebo groups and included eye irritation, posterior capsule opacification, increased intraocular pressure and anterior chamber inflammation. Omeros plans to launch the product in late summer/
early fall.

The company will undertake a study on Omidria in pediatric patients, which may grant an additional six months of marketing exclusivity if the study is successfully completed. 

2014 Helen Keller Achievement
Awardees announced

The American Foundation for the Blind (AFB, New York) has announced the recipients of its prestigious Helen Keller Achievement Awards: Christine Ha, winner of U.S. MasterChef Season 3, AT&T, and Genentech for their extraordinary efforts to improve quality of life for people with vision loss. Ms. Ha gained fame by being the first-ever blind winner of a major cooking show.

The 2014 awards will be presented June 17 in New York. Past awardees include companies such as IBM, The New York Times, Bank of America, and Time Warner, and individuals such as Stevie Wonder, Patty Duke, and Ray Charles.

A group of German researchers have started pre-clinical studies for the first implantable, permanent extraocular sensor, measuring intraocular pressure (IOP), developer Implandata Ophthalmic Products (Hannover, Germany) stated in a news release.

This proof-of-concept study hopes to demonstrate product and procedure safety, Implandata said. The permanent sensor is implanted in pseudophakic patients, and the less invasive extraocular sensor implants can be used in phakic patients.

Patients can perform IOP measurements by themselves at home under normal life conditions, the company added. Study investigators said the device is "the next step to personalized glaucoma therapy and will be an effective tool to monitor IOP even out of medical practice hours and thus help us prevent progression of IOP-associated optic neuropathy."

Trabodenoson shows promise in
glaucoma study

A preclinical study demonstrated the ability of trabodenoson, an adenosine A1 mimetic in development for glaucoma, to protect against the loss of retinal ganglion cells in an acute high ocular pressure animal model of glaucoma, developer Inotek (Lexington, Mass.) said in a
news release.

This preclinical neuroprotection study was designed to compare the protective effects of trabodenoson and brimonidine in a rat model of ischemia-induced retinal ganglion cell (RGC) death. Trabodenoson was delivered as an eye drop at a clinically relevant dose. Results of the study showed that trabodenoson provided 100% protection against the thinning of the ganglion cell layer (P≤0.001 compared to vehicle-treated eyes).

In a clinical Phase 2b trial, trabodenoson was found to be safe and well tolerated as a single agent, with intraocular pressure (IOP) lowering efficacy in the range of the prostaglandin analogs. Another Phase 2b clinical study of trabodenoson in combination with latanoprost is ongoing. Top line data from the latter study is expected in the fourth quarter. 

IOPtiMate to be distributed in China

IOPtima (Tel Aviv, Israel) has signed an exclusive distribution agreement for the sale and marketing of the IOPtiMate system in China, parent company BioLight Life Sciences said, adding part of the agreement is a guarantee of at least 100 systems.

The IOPtiMate system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in postoperative complications and use of eye drops compared with alternatives, BioLight said.

RESEARCH BRIEFS

• Eyes that underwent Descemet's stripping automated endothelial keratoplasty (DSAEK) surgery have thicker corneas with steeper posterior corneal curvature than fellow eyes that underwent Descemet's membrane endothelial keratoplasty (DMEK), according to Y. Goldich and colleagues. This difference may explain the hyperopic shift commonly observed after DSAEK and should be considered when choosing an intraocular lens for cataract surgery, the group advises. In their retrospective analysis of 20 eyes of 10 patients that underwent DSAEK in one eye and DMEK in the fellow eye, no significant differences were observed between front flat Ks (43.01±1.6 vs. 43.5±0.9, P=0.27) and front steep Ks (44.17±1.5 vs. 44.52±0.7, P=0.39) in DMEK vs. DSAEK eyes, accordingly. Posterior curvature was statistically significantly flatter in DMEK compared with DSAEK eyes; back flat Ks, back steep Ks, and back Km, accordingly. Corneas in DMEK eyes were significantly thinner than in DSAEK eyes (541.0±61 vs. 627.9±70 μm, P=0.007). The study is published in Cornea.
• Bromfenac ophthalmic solution 0.07% dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures, according to Steven M. Silverstein, MD, and colleagues. In two phase 3 double-masked, placebo-controlled, multicenter clinical trials, the researchers randomized 440 subjects to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with IOL implantation (day −1) and again on the day of surgery (day 0) and for 14 days postoperatively. The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 and continued through day 15. At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects in the placebo group. The overall anterior chamber cell scores and summed ocular inflammation scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15. The study is published in Clinical Ophthalmology.
• Phacoemulsification with posterior chamber IOL implantation results in a higher anterior chamber depth, angle, and volume, when compared to laser peripheral iridotomy (LPI) in the management of chronic primary angle closure (CPAC), according to A. Dias-Santos and colleagues. Their prospective case control study randomly divided 30 eyes (30 patients) into one of the two groups. Patients in the LPI group underwent LPI using argon and Nd:YAG laser. Patients in the IOL group underwent phacoemulsification with posterior chamber intraocular lens (IOL) implantation. The mean follow-up time was 31.13±4.97 months. There was a statistically significant reduction in the intraocular pressure (IOP) and number of anti-glaucoma medications (P<0.01) only in the IOL group. Anterior chamber depth, angle, and volume were all higher in the IOL group (P<0.01) at the end of the follow-up period. The study is published online ahead of print in International Ophthalmology.