A New Drug Application for Dextenza, a sustained release dexamethasone intracanalicular depot for the treatment of ocular pain following ophthalmic surgery, has been accepted by the Food and Drug Administration, said developer Ocular Therapeutix (Bedford, Mass.). The data included in the NDA are from a phase 2 clinical trial and two phase 3 clinical trials, the company said. Dextenza is placed through the punctum into the canaliculus and is designed to deliver dexamethasone to the ocular surface for 4 weeks; after treatment the depot resorbs and exits through the nasolacrimal system without need for removal.

The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 24, 2016.

A phase 2 study on CF101, an oral compound for the treatment of glaucoma, has completed patient enrollment, OphthaliX (Carson City, Nev.) said in a press release. The study has enrolled 88 patients in Europe and Israel; top line results are expected in mid-2016.

The study is being conducted with 2 cohorts. In the first cohort, patients were treated with 1 mg CF101 and placebo. Masked results from this cohort showed that the drug had a favorable safety profile and was well tolerated, OphthaliX said. In the second cohort, dosage was increased, with patients receiving 2 mg of CF101 and matching placebo, given orally every 12 hours for 16 weeks.

A 6-month, randomized, masked, sham-controlled phase 3 study (dubbed "Peachtree") of the safety and efficacy of CLS-TA (triamcinolone acetonide) administered via microinjection to the suprachoroidal space in patients with macular edema associated with non-infectious uveitis has enrolled its first patient, developer Clearside Biomedical (Alpharetta, Ga.) said in a news release.

The primary endpoint of the study is the proportion of patients with a change from baseline of at least 15 letters in BCVA at 24 weeks. Patients will be randomized to receive 2 unilateral injections of 4 mg of CLS-TA or sham injections about 12 weeks apart.

Clearside expects to enroll approximately 150 patients across 50 clinical sites. Assuming the trial is successful, Clearside hopes to file for regulatory approval some time in 2017.

Researchers at the University of Illinois have developed a portable sensor that can quickly and inexpensively determine whether an eye injury is mild or severe, the university said in a news release.

OcuCheck works by measuring levels of vitamin C in the fluids that coat or leak from the eye. The sensor could speed efforts to determine the extent of eye injuries at accident sites, in rural areas lacking ophthalmology specialists, or on the battlefield, the researchers said.

"The sensor takes advantage of the fact that the ocular tear film contains low levels of ascorbic acid, while the interior of the eye contains much higher levels," said University of Illinois bioengineering professor Dipanjan Pan, who is creating the device in collaboration with ophthalmologist Leanne Labriola, MD. "The concept is if there is severe damage to the eye that penetrates deeply, the ascorbic acid will leak out in high concentration."

In tests with clinical samples from 16 patients undergoing eye surgery, the team found that their sensor could, with high sensitivity, accuracy, and specificity, detect a range of ascorbic acid concentrations. The device has not been tested yet on tear samples from trauma patients.

Alcon (Fort Worth, Texas) opened the Alcon Experience Center to provide hands-on training for physicians in a "realistic practice environment," the company said. The center will also host high school and university students throughout the north Texas region as part of its efforts to promote education in science, technology, engineering and math (STEM), Alcon said.