The China Food and Drug Administration has granted regulatory approval for the KXL Cross-Linking System, developer Avedro (Waltham, Mass.) said in a news release. The device is indicated to treat keratoconus and post-LASIK ectasia. The KXL Cross-Linking System is the first and only corneal cross-linking device to receive marketing approval in China, Avedro added. 

The system is awaiting regulatory approval in the U.S.

The European Commission has approved Eylea (aflibercept) for the treatment of visual impairment due to myopic choroidal neovascularization (mCNV), Bayer Healthcare (Berlin, Germany) said. Approval was granted based on phase 3 study results where "the majority of patients experienced a significant 2-line improvement in visual acuity on a standard eye chart," the company said.

A topical formulation of a novel small molecule TrkA agonist for the treatment of dry eye disease, tavilermide, will be jointly developed and commercialized by Allergan (Dublin) and Mimetogen Pharmaceuticals (Montreal), the companies announced. Tavilermide is currently in two multicenter phase 3 studies; phase 2 study results indicated "significant improvements in both signs and symptoms [of dry eye] with 1% tavilermide versus placebo, together with strong safety, comfort and tolerability profiles," Allergan said.

Tavilermide is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye responsible for the maintenance of corneal nerves and epithelium. Tavilermide is differentiated from other investigational therapies in dry eye disease "because it induces the production of mucin, a naturally occurring component of the tear film, and works upstream prior to inflammation," Allergan said.

"It's not everyday that one newly discovers parts of the human body," says Roy S. Chuck, MD, PhD, Chairman Department of Ophthalmology and Visual Sciences, Albert Einstein College of Medicine (New York). Yet his lab team, in collaboration with Prof. Choul Yong Park, a visiting scientist on sabbatical from Dongguk University, South Korea, have done just that.

In a recent published study, they describe two novel structures in the cornea of the human eye: the anterior limbal cribriform layer and presumed anchoring fibers. These structures have never been described by any means before, and were discovered by using an advanced spectroscopic technique (second harmonic generation imaging microscopy).

While the function of the collagen/elastin-containing anterior limbal cribriform layer remains unknown, it may play a supportive function as it is composed of structural proteins, passes vasculature, and underlies a stem cell region of the eye.

A multi-center, prospective study that evaluated the visual acuity of 188 subjects with presbyopia who received the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, Calif.) in their non-dominant eye resulted in mean postoperative visual acuities of 20/25 for near vision, 20/25 for intermediate vision, and 20/32 for distance vision, the company said. Binocularly, the subjects were all 20/25 at distance. The company said this clinical data demonstrates "significant improvements" in near and intermediate vision. Detailed results from the study are published in Journal of Cataract & Refractive Surgery.

EGP-437, an iontophoretic ophthalmic solution for patients with macular edema, has shown promising interim results in a phase 1b/2a trial, developer Eyegate Pharmaceuticals (Waltham, Mass.) said, with pseudophakic eyes responding better than phakic eyes. 

The ongoing study is a multicenter, open-label trial that has enrolled 19 patients with macular edema associated with retinal vein occlusion, diabetic retinopathy or cystoid macular edema. The primary objective of this trial was to evaluate the safety and efficacy of iontophoretic EGP-437 in patients suffering from macular edema. Three treatments at 14.0 mA-min (3.5mA) were administered on day 0, day 4 and day 9. Primary outcome of the trial measured reduction in mean central subfield thickness on day 4, day, 9 and day 14. Ozurdex (dexamethasone, Allergan, Dublin) was administered as control to patients that did not respond to the investigational therapy at day 14 and were re-evaluated at day 28.

To date, there have been no serious treatment emergent adverse effects including no increase in ocular pressure even at three times the iontophoretic dose that was used for the EyeGate's Phase 3 non-infectious anterior uveitis trial. 

An extension stage of the trial will recruit an additional 15 patients and is scheduled to begin by the end of the year, with topline results in mid-2016. 

The inaugural PGBio Innovation in Ophthalmology Award will support entrepreneurs in the area of ophthalmology by providing financial help as well as assistance with strategic planning, Point Guard Biosciences (Tampa, Fla.) said. The PGBio team will choose the winner based on novelty of the medical research and the ability of the project to improve the patients' quality of life. The winner will be awarded a cash prize of $10,000, and will receive assistance from the PGBio team with the development of a business plan.

The submission deadline is January 22, 2016, and the award recipient will be announced April 21, 2016.