The Food and Drug Administration sent a complete response letter to Avedro (Waltham, Mass.) on its riboflavin ophthalmic solution/KXL System for corneal crosslinking (CXL), the company said. FDA identified "a small number of areas of the application concerning the device that require additional information, none of which pertain to the clinical study safety or efficacy data presented in the New Drug Application," Avedro stated in a press release.

LENSAR (Orlando, Fla.) received 510k clearance from the Food and Drug Administration for a suite of 5 new application technologies integrated into the company's laser system. The 5 new applications are wireless integration with the Cassini Corneal Shape Analyzer, iris registration, cataract density imaging, customized fragmentation patterns, and arcuate incision planning.

Positive top-line results from a phase 3 clinical trial of KPI-121, a nanoparticle loteprednol etabonate mucus-penetrating particle (MPP) product candidate, for the treatment of inflammation and pain in patients who had undergone cataract surgery, have been released, developer Kala Pharmaceuticals (Waltham, Mass.) said in a press release. KPI-121 achieved all primary efficacy endpoints and was generally well tolerated, with no significant treatment-related safety findings observed during the course of the trial.

The phase 3 multicenter, randomized, double-masked, vehicle-controlled, parallel-group trial in 380 patients was designed to evaluate 2 dosing regimens of KPI-121 ophthalmic suspension versus vehicle in patients undergoing cataract surgery. At day 8, statistically significant differences favoring KPI-121 were achieved for the primary endpoint of complete resolution of inflammation with both 1% KPI-121 dosed twice a day (P=0.0024) and 0.25% KPI-121 dosed 4 times a day (P<0.0001).

The phase 1/2 studies for dry age-related macular degeneration (AMD) and Stargardt macular degeneration (SMD) have completed dosing, Ocata Therapeutics (Marlborough, Mass.) said in a news release. The SMD trial will assess the safety and efficacy of subretinal transplantation of retinal pigment epithelial cells compared to an untreated control group. The endpoints of the trial include functional and anatomic outcome parameters. The AMD trial will evaluate the safety of different regimens of immunosuppressive therapy while exploring functional and anatomic efficacy outcome parameters.

RESEARCH BRIEFS

• Flap creation with the 150 kHz system and the 60 kHz system resulted in excellent LASIK outcomes, but patients preferred the 150 kHz system, which yielded better uncorrected distance visual acuity (UDVA) in the early postoperative period, according to Charles Q. Yu, MD, and Edward E. Manche, MD. They compared LASIK outcomes between 2 femtosecond lasers in 122 eyes of 61 patients. The prospective, randomized eye-to-eye study evaluated a flap created by the IntraLase FS 60 kHz femtosecond laser, and the fellow eye was treated with the IntraLase iFS 150 kHz femtosecond laser (Abbott Medical Optics, Abbott Park, Ill.). The mean preoperative spherical equivalent refraction was −4.62 D and −4.66 D in the 150 kHz group and 60 kHz group, respectively. Patients preferred the 150 kHz laser to the 60 kHz laser intraoperatively (52.5% versus 26.2%; P=.005). One week postoperatively, UDVA was 20/16 or better in 85.2% in the 150 kHz group and 70.5% in the 60 kHz group; the difference was statistically significant (P<.05). At 12 months, there were no significant differences in refractive outcomes or higher-order aberrations between the 2 groups. The study is published in the Journal of Cataract & Refractive Surgery.
• The single instillation of trehalose 30 mg/mL and sodium hyaluronate 1.5 mg/mL (TH-SH, Thealoz Duo) and hyaluronate, 0.15% (HA, Hyabak) eye drops increases tear film thickness (TFT) in patients with dry eye disease, according to a study. D. Schmidl and colleagues randomized 60 patients to TH-SH, HA, or sodium chloride 0.9% (NaCl, Hydrabak) in a double-masked, controlled parallel group design. The mean TFT before treatment was 2.5±0.4 μm. Ten minutes after instillation, TFT significantly increased in the TH-SH group from 2.4±0.4 to 3.1±0.9 μm (P<0.01) and in the HA group from 2.4±0.3 to 2.9±0.5 μm (P<0.01), whereas no significant change was observed in the NaCl group (from 2.6±0.4 to 2.7±0.4 μm, P=0.76). The increase in TFT remained statistically significant up to 240 minutes after administration of TH-SH. In contrast, the increase in TFT after administration of HA was only statistically significant at 10, 20, and 40 minutes after drop instillation. The study is published in Cornea.
• A new version of the Glaucoma Treatment Compliance Assessment Tool showed acceptable psychometric properties, according to G.T. Barker and colleagues. They administered the 47-statement Glaucoma Treatment Compliance Assessment Tool to 201 participants who were using a single bottle of an ocular hypotensive agent and objectively measured adherence with Medication Event Monitoring System devices over 60 days. The mean (+/-SD, range) adherence percentage was 79.9% (+/-18.5%, 20.3% to 100.0%). Multiple regression analysis showed 4 Health Belief Model statements, white race, older age, and married marital status to be associated with higher adherence (adjusted R2=0.27, P<.001). The study is published in the American Journal of Ophthalmology.

NEW PRODUCT BRIEFS

• Optos (London) launched the California, the company's next generation ultra-widefield imaging platform, the company said. California introduces Optos' newest imaging modality, indocyanine green angiography, while maintaining all current color imaging modalities, autofluorescence and fluorescein angiography. 
• FCI Ophthalmics (Pembroke, Mass.) has begun distributing the InVitria intravitreal injection assistant in several models to accommodate the syringes of various popular injectable therapeutic agents for age-related macular degeneration. The InVitria injection assistant, designed by Arnaldo Gonçalves, MD, the Netherlands, is a disposable device equipped with a guide tube that is specially oriented to ensure a fixed injection angle, position, and depth.