Shire (Lexington, Mass.) has submitted a New Drug Application (NDA) for dry eye treatment lifitegrast to U.S. regulators, the company announced.

Lifitegrast is a novel small-molecule integrin inhibitor. It binds to the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand ICAM-1 (intercellular adhesion molecule-1), Shire said. ICAM-1 is overexpressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction contributes to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.

Intravitreal sirolimus, an investigational mTOR inhibitor, for the treatment of non-infectious uveitis (NIU) of the posterior segment, has been filed for regulatory approval in Europe, developer Santen (Osaka, Japan) said in a press release.

The Xen 45 Gel Stent has completed enrollment in a prospective, multicenter single-arm clinical trial to evaluate the device in subjects with refractory glaucoma where previous glaucoma treatments were not effective, developer AqueSys (Aliso Viejo, Calif.) said in a news release.

The stent is the first glaucoma device designed to achieve similar intraocular pressure reduction as traditional subconjunctival trabeculectomy and tube shunt procedures through a minimally invasive technique with less associated surgical and postoperative risk, AqueSys said.

A phase 2 study of triamcinolone acetonide administered via suprachoroidal injection for the treatment of macular edema associated with retinal vein occlusion has enrolled its first patient, developer Clearside Biomedical (Alpharetta, Ga.) said in a press release.

RESEARCH BRIEFS

• While the surgical case order does not appear to affect complication rates of cataract surgery, the first case of the day was longer than subsequent cases, according to a new study. D. Gupta and colleagues compared intraoperative complication rates and case times for attending and resident surgeons for the first case of the day (considered the warm-up case) versus subsequent cases from the 1,424 patients who underwent phaco between June 2010 and December 2011 at the University of Washington Medicine Eye Institute (Seattle). Simple and complex surgeries were both evaluated, as determined by CPT codes. Cataract surgery complication rates were not statistically different between the first cases of the day and subsequent cases (3.3% versus 4.0%). There was, however, a significant difference in mean case time between these groups. The mean case time for simple phacoemulsification by resident physicians was 49.45±19.38 minutes for first cases and 42.27±15.78 minutes for subsequent cases (P=.021) and by attending physicians, 32.54±12.91 minutes and 26.69±9.17 minutes, respectively (P<.0001). The authors suggested a "preoperative warm-up exercise" might decrease surgical times. The study is published in the Journal of Cataract & Refractive Surgery.
• Two-year changes in severity of lens opacities on the Age-Related Eye Disease Study (AREDS) lens grading scale are predictive of long-term clinically relevant outcomes, making them potential surrogate endpoints in follow-up studies, according to M. Indaram and colleagues on behalf of the AREDS Research Group. They graded baseline and annual lens photographs of 3,466 AREDS participants for severity of cataracts using the AREDS system for classifying cataracts from photographs. The main outcomes measurements were progression of lens opacities on stereoscopic lens photographs at 2 years, cataract surgery, and visual acuity loss of 2 lines or more at 5 years. The adjusted hazard ratios (HRs) for association of progression to cataract surgery at 5 years were: nuclear cataract increase of 1.0 unit or more compared with less than 1.0-unit change at 2 years, 2.77 (P<0.001); cortical cataract increase of 5% or more in lens opacity in the central 5 mm of the lens compared with less than 5% increase at 2 years, 1.91 (P=0.002); and posterior subcapsular cataract increase of 5% or more versus less than 5% in the central 5 mm of the lens, 8.25 (P<0.001). Similarly, HRs of vision loss of 2 lines or more at 5 years for this degree of lens changes at 2 years were the following: nuclear, 1.83, and posterior subcapsular cataract, 3.05, both of which were statistically significant, and cortical, 1.13, which was not statistically significant. The study is published in Ophthalmology.
• Blebitis and bleb-related endophthalmitis are uncommon in the United States, with a 5-year cumulative incidence of 0.55% for blebitis and 0.45-1.3% for bleb-associated endophthalmitis, according to a retrospective, cross-sectional study. K. Vaziri and colleagues used a large commercial health insurance claim-based database to identify 1,461 patients who had undergone trabeculectomy in 2007. Patient data was analyzed through the end of 2011. There were 8 cases of blebitis, 5 cases of confirmed bleb-associated endophthalmitis, and 8 cases of presumed bleb-associated endophthalmitis. The 5-year cumulative incidence of bleb-associated endophthalmitis ranged in incidence when presumed cases were also included. The mean time from procedure to diagnosis was 45 months for blebitis and 33 months for bleb-associated endophthalmitis. The study is published in Clinical Ophthalmology.

NEW PRODUCT BRIEFS

• Carl Zeiss Meditec (Jena, Germany) launched the Humphrey Field Analyzer 3 (HFA3), its next generation perimetry device for visual field testing.
• Practice CoPilot (Jacksonville, Fla.) launched Maestro, a practice management platform that allows Bluetooth beacons strategically placed inside each practice to work in conjunction with mobile technology to pinpoint the exact location of every patient, staff member, and doctor in the practice. Color coding will give real time information about patient wait times in all areas of the practice.
• Opticomfort Therapeutic Eye Patches provide secure and comfortable eye protection by accommodating standard eye shields applied after ophthalmic surgeries or procedures. No placement of surgical tape is required. A specially sized hot/cold pack is also included. Ideal when thermal compress therapy is prescribed for a single eye. This patient-designed eye patch is safe, non-toxic, washable, and reusable. Adjustable adult and children sizes are available.