The European Medicines Agency has granted orphan drug designation to MI-100 for the treatment of Stargardt disease, developer Makindus (Doylestown, Pa.) said in a news release.

MI-100 is a novel formulation of a legacy compound that has been shown to have a clinical effect in improving visual acuity for Stargardt patients in an investigator-initiated clinical trial. The proprietary packaging for MI-100 is a single bottle, closed container mixing system that allows for a ready-to-use multi-dose eye dropper for easy administration, the company said.

A first-in-class peptide for inducing posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (DR) has begun enrolling patients in a phase 2 study, developer Allegro Ophthalmics (San Juan Capistrano, Calif.) said. Luminate targets integrin receptors involved in cell signaling and regulation.

This phase 2 study is a randomized, double-masked, placebo-controlled, multicenter dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of Luminate in patients with non-proliferative DR. Patients will be randomized to one of 4 treatment groups that include 3 Luminate groups (1.0 mg, 2.0 mg, or 3.0 mg) and a placebo group. All study subjects will return for examinations every 4 weeks for 3 months. Total planned enrollment for the trial is 100 subjects.

The sixth annual ARMOR (Antibiotic Resistance Monitoring in Ocular MicrooRganisms) surveillance study in the United States found high levels of resistance (both full and intermediate), Bausch + Lomb (Bridgewater, N.J.) said in a news release.

Researchers presented data on 496 bacterial isolates collected from 22 participating sites and preliminary 2014 data on 141 isolates collected from 7 participating sites. The survey included all of the organisms most frequently implicated in serious bacterial eye infections.

RESEARCH BRIEFS

• Two novel investigational artificial tear formulations (CHO-1 and CHO-2) were equally effective and safe in the treatment of dry eye, according to P.A. Simmons and colleagues. The drops contain carmellose sodium, hyaluronic acid at different concentrations, and osmoprotectants, with a standard carmellose sodium-containing formulation (Refresh Tears [RT]). The 3-month, double-masked, multicenter study randomized 305 subjects 1:1:1 to receive CHO-1, CHO-2, or RT, used as needed but at least twice daily. Ocular Surface Disease Index scores (OSDI) and dry eye symptoms showed a rapid and sustained reduction from baseline in each group. Both CHO-1 and CHO-2 met the primary efficacy endpoint of non-inferiority to RT in day 90 OSDI score change from baseline. OSDI ocular symptoms subscale improved more with CHO-1 than CHO-2 (P=0.048). In subjects with clinically relevant baseline ocular surface staining (>14 total score of a maximum of 55), day 90 improvements were greater with CHO-1 and CHO-2 than RT (P≤0.044). Day 90 improvements in OSDI ocular symptoms subscale scores were also greater with CHO-1 than RT (P<0.007) in subjects with clinically relevant ocular staining. The study is published in Clinical Ophthalmology.
• When comparing monocular and binocular mesopic contrast sensitivity and through focus after corneal inlay, accommodating, or multifocal IOL implantation, the demonstrated performance of these devices should be considered, along with subjects' visual demands and expectations, degree of crystalline lens dysfunction and other ocular characteristics, said S. Vilupuru and colleagues. They evaluated 507 subjects with KAMRA inlays (AcuFocus, Irvine, Calif.), with predetermined subgroups of 327 subjects who underwent contrast sensitivity testing and another 114 subjects for defocus curve testing, along with 78 subjects randomized among bilateral Crystalens Advanced Optics (AO) (Bausch + Lomb, Bridgewater, N.J.) and AcrySof IQ ReSTOR +3.0 D (Alcon, Worth, Texas) or Tecnis +4D Multifocal (Abbott Medical Optics, Abbott Park, Ill.) IOLs. The inlay subjects demonstrated improved intermediate and near vision with minimal to no change to distance vision, better contrast sensitivity in the inlay eye when compared to the multifocals, and better binocular contrast sensitivity when compared to all three intraocular lenses. Crystalens AO was superior in uncorrected intermediate vision to the KAMRA inlay but not distance-corrected intermediate and was worse in near vision. The multifocals were superior in near vision at their respective optimum near focus points, but worse in intermediate vision compared to both the KAMRA inlay and Crystalens AO. The study is published online ahead of print in the American Journal of Ophthalmology.
• Vacuum improved efficiency only up to 300 mm Hg and was more dependent on increasing flow, according to a new study in the Journal of Cataract & Refractive Surgery. Similarly, chatter correlated with 200 mm Hg vacuum only and was more correlated with flow. Isha Gupta, BS, and colleagues at the John A. Moran Eye Center (Salt Lake City) divided formalin-soaked porcine lenses into 2.0 cubes, and 0.9 mm, 30-degree beveled 20-degree bent tips were used with micropulse ultrasound (US) (6 milliseconds on and 6 milliseconds off) and a peristaltic flow system. Vacuum levels and aspiration rates were evaluated, as was time to lens removal and chatter. Increasing vacuum increased efficiency only when going from 200 mm Hg to higher vacuum levels. Increasing aspiration increased efficiency at all points measured. Chatter was highest at 200 mm Hg and decreased when vacuum was increased from 200 mm Hg to 300 mm Hg and up.

NEW PRODUCT BRIEFS

• Geuder (Heidelberg, Germany) introduced the Brilliant Peel Dual Dye for selective staining of the internal limiting membrane (ILM). The new dual dye stains much more intensely and features a selective and in contrast clearly differentiable staining of ILM, epiretinal membranes (ERM) and vitreous remnants, the company said. Brilliant Peel Dual Dye is available as a 0.5 ml vial or syringe.
• Vital Art and Science (Richardson, Texas) introduced the mVT Service, a medical device and physician portal that tracks the progression of vision damaging diseases such as age-related macular degeneration (AMD) and diabetic retinopathy (DR), according to a company news release. The device is available only by prescription and consists of an easily downloaded app that can be used on any Apple smartphone or tablet. The mVT Service is "the only simple, low cost, mobile, validated method available for these patients to test their vision at home," according to Vital Art and Science.