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Volume 21, Number 04
29 January 2016



Lifitegrast resubmitted to FDA

The New Drug Application for lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults, has been resubmitted to the Food and Drug Administration (FDA), developer Shire (Lexington, Mass.) said in a news release.

Addressing the FDA request for an additional study, Shire included in its NDA resubmission package data from OPUS-3, a phase 3 efficacy and safety trial with a primary endpoint of patient-reported symptom improvement. The resubmission package also included information requested by the FDA regarding product quality.

Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA on October 16, 2015.

The new drug application for lifitegrast now includes data from 1 phase 2 study, 3 phase 3 efficacy and safety studies (OPUS-1, OPUS-2, and OPUS-3), and 1 long-term (1-year) phase 3 safety study (SONATA).




First patient dosed in phase 2/3 GA study

A phase 2/3 study of Zimura (avacincaptad pegol sodium), an inhibitor of complement factor C5, in patients with geographic atrophy, has begun dosing enrolled subjects, developer Ophthotech (New York) said in a press release. A phase 2 study of Zimura in combination with antivascular endothelial growth factor therapy in wet age-related macular degeneration patients has just begun enrollment, the company said.




Topical presbyopia treatment study completes enrollment

EV06, a topical ophthalmic solution for the treatment of presbyopia, has completed enrollment in a phase 1/2 clinical study, developer Encore Vision (Fort Worth, Texas) said in a press release.

EV06 (lipoic acid choline ester, 1.5%) is a first-in-class new chemical entity that targets a biochemical cause of presbyopia believed to be associated with an increase in the formation of disulfide bonds between the crystalline proteins within lens fiber cells. EV06 is intended to increase lens flexibility by breaking these bonds, thereby restoring elasticity, allowing the lens to focus on nearby objects. EV06 is a prodrug that penetrates the cornea and is subsequently broken down into lipoic acid and choline.

The phase 1/2 prospective, randomized, double-masked, multicenter study is examining the safety and efficacy of EV06 compared to placebo over 90 days for the treatment of presbyopia. Four sites across the United States enrolled a total of 75 subjects between the ages of 45 and 55 with distance corrected near visual acuity (DCNVA) worse than 20/40 and best corrected distance visual acuity (BCDVA) of 20/20 or better in each eye. The study has enrolled myopic, hyperopic, and emmetropic presbyopes. The primary outcome is mean change in DCNVA and BCDVA. To date, no safety or tolerability issues have been reported.

Results from the study are expected in the second quarter of 2016.




Chickenpox, shingles vaccine may cause corneal inflammation

The World Health Organization considers the varicella zoster virus vaccine for chickenpox and shingles an essential medicine, but "in rare instances, a link between the vaccine and corneal inflammation" has been found, according to researchers from the University of Missouri School of Medicine, Columbia, Mo.

Frederick W. Fraunfelder, MD, and others at the University of Missouri Mason Eye Institute studied case reports from both national and international registries and found "at least 20 cases of keratitis occurred in children and adults within a month of administration of the chickenpox and shingles vaccine," he said.

For adults, symptoms of keratitis developed within 24 days of vaccination. For pediatric patients, symptoms of inflammation developed within 14 days.




RESEARCH BRIEFS

  • Cataract surgery should be recommended for advanced glaucoma patients with stable intraocular pressure (IOP), according to X. Xuand colleagues. They evaluated the longitudinal postoperative vision-related quality of life and visual acuity changes after cataract surgery in 93 patients with advanced glaucoma (defined here as near total cupping of the optic nerve with severe visual field loss within 10 degrees of fixation). Standard phaco and IOL implantation were performed. The overall changes in the Chinese-version of the Low Vision Quality of Life Questionnaire (CLVQOL) composite scores ranged between 4 and 42 (median=19). Statistically significant increases occurred in the composite scores of all of the subscales, the total CLVQOL, the BCVA in the surgery eye, and the weighted average logMAR (WMAR) (all P<0.001). Greater increases in the CLVQOL composite scores were associated with superior preoperative WMAR and a younger age. The study is published in theJournal of Glaucoma.

  • Strabismus surgery may not be necessary to eliminate diplopia that develops following secondary IOL placement in patients with sensory strabismus from uncorrected monocular aphakia, according to a new study. Y.J. Ahn and colleagues retrospectively compared the clinical characteristics between diplopia-free and diplopia-persistent patients after successful strabismus surgery, when patients complained of diplopia following secondary IOL implantation after prolonged aphakia accompanied by sensory strabismus. Of the 31 patients, the diplopia-persistent group showed longer duration of uncorrected aphakia (P=0.02), less severe corneal astigmatism (P=0.04), a smaller exodeviation angle (P=0.02), and more frequent vertical deviation (P=0.015), extorsion (P=0.022) and monocular nystagmus (P=0.028) than the diplopia-free group. In all patients in the diplopia-free group, diplopia could be eliminated prior to strabismus surgery using loose prisms in free space, whereas 7 patients in the diplopia-persistent group prior to surgery could not resolve diplopia. The study is published in Graefe's Archives of Clinical and Experimental Ophthalmology.

  • The topical nonsteroidal anti-inflammatory drugs (NSAIDs) ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1% were effective for the reduction of postoperative inflammation following phacoemulsification, according to Sabin Sahu and colleagues. In their prospective, randomized case series, patients with age-related cataract having phacoemulsification with PC IOL implantation were randomized into 4 groups receiving topical ketorolac 0.4% (Group A; n=33), bromfenac 0.09% (Group B, n=30), nepafenac 0.1% (Group C, n=31), or no NSAIDs (Group D, control; n=26). The laser flare photometry values at the end of 4 weeks and 8 weeks were minimal in the nepafenac group compared with the other NSAID groups and the no NSAID group (P=.032 at 4 weeks and P=.252 at 8 weeks). The study is published in the Journal of Cataract & Refractive Surgery.

  • Combining ab interno trabeculectomy and cataract surgery reduced short-term postoperative IOP and the incidence of IOP spikes despite the common hyphema, according to Yotam Weiner and colleagues. In this retrospective, interventional, nonrandomized comparative chart review, 73 eyes (combination group) and 75 eyes (cataract-only group) were evaluated. The mean preoperative IOP was 15.8±3.6 mm Hg and 14.9±3.0 mm Hg, respectively. In the combined group, the IOP decrease was significant at 3 to 4 hours (P=.0003) and 20 hours (P=.0007). In the cataract-only group, the IOP increased significantly (P<.0001 and P=.0035, respectively). The mean IOP was significantly lower in the combined group than in the cataract-only group at 3 to 4 hours (12.8±5.9 mm Hg vs. 19.7±7.5 mm Hg) and 20 hours (12.7±7.0 mm Hg vs. 17.2±5.9 mm Hg) (both P<.0001). Significantly fewer eyes in the combined group than in the cataract-only group had IOP spikes. Hyphema occurred in 35 eyes (47.9%) in the combined group; however, the IOP was similar with or without hyphema. The study is published in the Journal of Cataract & Refractive Surgery.



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