The U.S. Food and Drug Administration expanded the approved use for Eylea (aflibercept, Regeneron Pharmaceuticals, Tarrytown, N.Y.) injection to include diabetic retinopathy (DR) in patients with diabetic macular edema (DME), the FDA said in a news release.

Eylea has been approved with a 5-month loading dose and then every 2 months, the FDA said. Additionally, the treatment has been granted "breakthrough therapy designation" for this indication, FDA said.

The European Commission granted approval of the Marketing Authorization Application (MAA) for Ikervis (ciclosporin) for treatment of severe keratitis in adult patients with dry eye disease that has not improved despite treatment with tear substitutes, developer Santen (Osaka, Japan) said in a news release. Ikervis is the first pharmacologic intervention for the treatment of severe keratitis in adult patients with dry eye disease in Europe.

A phase 3 registration trial, dubbed "Rocket 2," on Rhopressa, a once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, has completed enrollment, developer Aerie Pharmaceuticals (Irvine, Calif.) said in a news release.

Rocket 2 will measure efficacy over 3 months, as well as safety over 1 year. The primary efficacy endpoint of the trial is to demonstrate non-inferiority of IOP lowering for Rhopressa compared to timolol.

Data from the company's Rocket 1 study, a 90-day efficacy registration trial, are expected mid-second quarter.

Ocata Therapeutics (Marlborough, Mass.) will enroll about 100 patients in its retinal pigment epithelium program for Stargardt macular degeneration (SMD) after receiving written formal guidance from European regulators, the company said.

Positive topline results from the OASIS study on Jetrea (ocriplasmin, ThromboGenics, Leuven, Belgium) found 41.7% of those treated with Jetrea achieved vitreomacular adhesion (VMA) resolution at day 28 post-injection, the company said.

The University of Washington and Avalanche Biotechnologies will jointly develop potential treatments for color vision deficiency (CVD). University of Washington researchers used gene therapy to confer color vision in 2 adult male squirrel monkeys that had been colorblind since birth. Avalanche is developing 2 separate gene therapies for this disorder, 1 that treats the protan defects and 1 that treats the deutan defects (long and middle wavelengths, respectively). The most common forms of CVD are due to genetic defects that lead to missing either the L-opsin (protan defects) or the M-opsin (deutan defects).

RESEARCH BRIEFS

• A new study shows the beneficial effect of collagen crosslinking (CXL) in patients with moderate bacterial keratitis. S. Bamdad and colleagues enrolled 32 patients with moderate bacterial keratitis who were randomized to either case or control. The case group received CXL treatment. In the CXL group, corneal epithelium was removed and 0.1% riboflavin drops were applied. Then the corneas were irradiated with UV-A (365 nm) with an irradiance of 3 mW/cm for 30 minutes. The grade of ulcers, size of epithelial defects, and area of infiltrates were recorded on days 1, 7, and 14 of treatment. The mean treatment duration was 17.2±4.1 days in the CXL group and 24.7±5.5 days in the control group. The epithelial defects were smaller in the CXL group at 7 days (P=0.001) and 14 days (P=0.001) after the beginning of treatment. The area of infiltrates in the CXL group was smaller than the control group at both 7 days (P=0.001) and 14 days (P<0.001) after the start of treatment. The study is published in Cornea.
• Perfluorocarbon liquid (PFCL) and fibrin glue-assisted IOL sutureless scleral refixation or exchanged fixation was an effective surgical treatment for IOL dislocation in a small study. S.Y. Oh and colleagues evaluated 25 eyes (25 patients) who underwent surgery for dislocated IOLs with PFCL and fibrin glue-assisted scleral fixation; 13 eyes experienced IOL refixation (in-the-bag and out-of-the-bag), and 12 eyes experienced IOL exchange. At postoperative 6 months, best corrected visual acuity and spherical equivalent of IOL refixation and exchange were significantly improved (P=0.042, P=0.001), and endothelial cell density was significantly decreased in the 2 groups with no significant difference between them. Surgically induced astigmatism of IOL refixation improved from 0.90±0.47 to 0.61±0.37 (P=0.012), and IOL exchange improved from 1.17±0.64 to 0.73±0.37 (P=0.037) at postoperative 6 months, with no significant difference between the 2 groups. The study is published in Eye.
• Visual and economic benefits for the patient can be achieved with same-day bilateral cataract surgery, according to S.W. Rush and colleagues. They age-matched a cohort of patients having same-day bilateral cataract surgery with a cohort of control patients who had standard separate-day bilateral cataract surgery. The same-day cohort (42 patients, 84 eyes) had less total distance traveled for care (P=.0039 and P<.0001 for in-town and out-of-town residents, respectively), less total time spent traveling for care (P=.0008 and P<.0001 for in-town and out-of-town residents, respectively), less total number of visits required for care (P<.0001), and less total time for vision recovery (P<.0001) than the control cohort (42 patients, 84 eyes). Both physician and ASC reimbursements were lower in the same-day cohort, but total physician time spent on patient care did not differ between the 2 cohorts. The total ASC expenses were higher in the same-day cohort (P<.0001). The total third-party payer cost was significantly less in the same-day cohort (P<.0001). The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

• Akorn (Lake Forest, Ill.) launched Phenylephrine HCl Ophthalmic Solution, USP, 2.5% and 10%, a topical mydriatic solution. The solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil and is available in 2-, 10-, and 15-mL fill sizes, depending on concentration.
• Bausch + Lomb (Bridgewater, N.J.) introduced an enhanced BLIS Injector System to allow physicians to implant the company's enVista IOL through an unenlarged 2.2 mm incision.
• Reichert Technologies (New York) launched its Phoroptor VRx digital refraction system. The Phoropter features fast and quiet lens exchanges, motorized prism compensators, and a split cylinder lens.
• TrueVision 3D Surgical (Santa Barbara, Calif.) introduced an ultra high-definition 4K 3D display for the digital platform for surgical microscopes, "a unique technology that converts an optical microscope into a powerful digital imaging system," the company said.