Ozurdex granted U.S. approval

The Food and Drug Administration has granted approval for Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of diabetic macular edema (DME) in adult pseudophakic patients, developer Allergan (Irvine, Calif.) said in a news release. The implant uses a solid polymer delivery system that releases medicine over an extended period of time.

Eylea recommended for DME in Europe

Eylea (aflibercept, Bayer Healthcare, Leuven, Germany) has been recommended for approval by the European Committee for Medicinal Products for Human Use for the treatment of visual impairment due to DME. The decision of the European Commission is expected in the second half of 2014, the company announced.

Telemedicine catches blinding disease in premature babies

Telemedicine is an effective strategy to screen for the potentially blinding disease known as retinopathy of prematurity (ROP), according to a study funded by the National Eye Institute (NEI, Bethesda, Md.). The investigators say that the approach, if adopted broadly, could help ease the strain on hospitals with limited access to ophthalmologists and lead to better care for infants in underserved areas of the country.

The telemedicine strategy consisted of electronically sending photos of babies' eyes to a distant image reading center for evaluation. Staff at the image reading center, who were trained to recognize signs of severe ROP, identified whether infants should be referred to an ophthalmologist for evaluation and potential treatment. The study tested how accurately the telemedicine approach reproduced the conclusions of ophthalmologists who examined the babies onsite.

The study evaluated telemedicine for ROP screening during the usual care of 1,257 premature infants who were born, on average, 13 weeks early. About every nine days, each infant underwent screening by an ophthalmologist, who assessed whether referral for treatment was warranted. Those who were referred were designated as having referral-warranted ROP (RW-ROP). Either immediately before or after the exam, a non-physician staff member in the neonatal intensive care unit (NICU) took images of the infant's retinas and uploaded them to a secure server at the University of Oklahoma, Oklahoma City. Trained non-physician image readers at the University of Pennsylvania, Philadelphia, then downloaded the photos, independently evaluated them following a standard protocol, and reported the presence or absence of RW-ROP.

Through the telemedicine approach, non-physician image readers correctly identified 90% of the infants deemed to have RW-ROP based on examination by an ophthalmologist. They were correct 87% of the time when presented with images from infants who lacked RW-ROP. The examining ophthalmologists documented 244 infants with RW-ROP on exam. After referral, 162 infants were treated. Of these, non-physician image readers identified RW-ROP in all but three infants (98%).

Squalamine/Lucentis combo show positive interim results

Patients treated with a combination of squalamine eye drops and antivascular endothelial growth factor intravitreal injection Lucentis (ranibizumab, Genentech, South San Francisco) demonstrated a 65% "additional relative benefit in visual acuity versus placebo eye drops plus Lucentis PRN," Ohr Pharmaceuticals (New York) said in a news release.

Top-line interim results from a double-masked, placebo-controlled phase 2 clinical trial demonstrated a positive benefit in visual function across multiple clinically relevant endpoints, including a mean change in visual acuity at the end of the study visit for the interim analysis group of +10.4 letters with squalamine eye drops plus Lucentis PRN versus +6.3 letters in the placebo eye drops plus Lucentis PRN arm (P=0.18). The primary endpoint was the mean number of Lucentis injections, and secondary endpoints included visual acuity as well as diagnostic imaging outcomes. This analysis failed to meet the primary endpoint of reducing the number of Lucentis injections needed when squalamine was added to the treatment regimen.

The interim analysis was conducted on the first 62 patients (29 in the squalamine arm) who completed the entire 9-month study. In the interim analysis group, 48.3% of squalamine-treated patients showed BCVA gains of ≥ 15 letters on a standard ETDRS eye chart, compared with 21.2% in the placebo arm at the end of the study (P=0.025).

RESEARCH BRIEFS

• Preoperative biometry can be used to estimate contact lens power for distance if an accurate refraction cannot be obtained initially, according to R. H. Trivedi and colleagues for the Infant Aphakia Treatment Study (IATS). They retrospectively analyzed 34 eyes of 34 patients that had both a preoperative immersion axial length measurement and a 1-month postoperative refractive value. The target contact lens power for distance was determined using 1-month postoperative spherical equivalent refraction (after adjusting for a vertex distance) over the known contact lens power. Age at the time of cataract surgery was 2.4±1.7 months. Follow-up refraction was performed at 31±3 days after surgery. Target contact lens power for distance was 26.0±4.5 D for the IATS cohort (which excluded infants with corneal diameter <9 mm). The mean prediction error was -4.0, -1.0, and -2.0 D, and mean absolute prediction error was 4.4, 2.2, and 2.9 D, respectively, for 30 D contact lens, regression, and SRK/T-estimated power. The study is published in the Journal of the AAPOS.
• The Supracor presbyopia procedure showed good near visual acuity outcomes over 6 months of follow-up, but loss of corrected distance visual acuity (CDVA) occurred in 39.1% of eyes, according to a study from C.B. Cosar and A.B. Sener. They prospectively enrolled 123 eyes from 68 presbyopic patients with hyperopia in their nonrandomized, clinical trial. The Supracor procedure was performed using the Technolas excimer laser 217P (Technolas Perfect Vision, Munich, Germany). Follow-up eye examinations were performed at postoperative day 1, month 1, and month 6. At 6 months postoperatively, uncorrected distance visual acuity was 20/20 or better in 27 (22.0%) eyes and 20/25 or better in 45 (36.6%) eyes. At 6 months postoperatively, 35 (28.5%) eyes lost 1 line and 13 (10.6%) eyes lost 2 lines of CDVA. Uncorrected near VA was 20/20 or better in 95 (77.2%) eyes and 20/25 or better in 110 (89.4%) eyes. The study is published in the European Journal of Ophthalmology.
• The duration and pattern of the action may vary according to types of nonsteroidal anti-inflammatory drugs (NSAIDs) after photorefractive keratectomy (PRK), according to Jin Pyo Hong, MD, and colleagues. They randomly assigned 94 patients to one of two groups: ketorolac group (ketorolac 0.5% in 1 eye and ofloxacin 0.3% in the other eye) and diclofenac group (diclofenac 0.1% in 1 eye and ofloxacin 0.3% in the other eye). One drop of each ophthalmic drug was applied 3 times to each eye 30 minutes before PRK; no other NSAID was prescribed until 4 days postop. Peak of pain was located between 24 and 36 hours. Initially, the degree of pain reduction was constant for both NSAIDs; it dropped after 24 hours and 36 hours in the ketorolac group and the diclofenac group, respectively. The visual outcome was not affected by either NSAID, and significant complications were not noticed for a mean of 7 months. The article is published online ahead of print in Journal of Cataract & Refractive Surgery.