EyeWorld Weekly Update, May 4, 2018

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May 4, 2018
Volume 24 , Number 15

Clinically significant activity found for topical ocular 0.1% reproxalap for dry eye

Data from a Phase 2a randomized, double masked, parallel group Phase 2a clinical trial of topical ocular reproxalap (Aldeyra Therapeutics, Lexington, Massachusetts) found that dry eye patients treated with the agent had statistically significant improvement from baseline in tear volume and statistically and clinically significant improvement in the Overall 4-Symptom Score and the Ocular Discomfort Score. Tear levels of pro-inflammatory reactive aldehyde species, which are sequestered by reproxalap, significantly lowered after treatment. In the study, 51 subjects with active dry eye disease were randomized to receive 0.1% reproxalap, 0.5% reproxalap, or a 0.5% liquid formulation of reproxalap four times a day. All groups had significant changes in various symptom scores, osmolarity, and corneal staining. Tolerability was consistent with standard of care in dry eye, according to the company. A Phase 2b trial for topical ocular reproxalap began in January and is expected to enroll 300 patients; those trial results are expected to be announced in the second half of this year.

Topline final data presented for Lightsite 1 for dry AMD

Final results from the Lightsite 1 clinical trial to treat dry age-related macular degeneration (AMD) showed that Lightsite 1 (LumiThera, Seattle) led to reductions in central drusen volume over the study's 1-year time period compared with sham treatment, with statistical significance at 1 year, according to a company press release. "Results from the Lightsite 1 study following treatment with a multi-wavelength photobiomodulation [PBM] treatment demonstrated clinical improvements in vision outcome measures, providing a strong foundation for initial therapy as well as the need for follow-up maintenance therapy," said co-principal investigator Samuel Markowitz, MD, in a press release. The PBM therapy appeared to help patients the most when done immediately after treatment sessions. The pilot study included 30 subjects and was partially funded by a Small Business Innovation Research grant from the National Institutes of Health and the National Eye Institute. Each subject's vision and disease pathology after PBM treatment was evaluated for up to 1 year.

Phase 3 data for neovascular AMD treatment shows reliability

Phase 3 data for brolucizumab (RTH258, Novartis, Basel, Switzerland) for neovascular AMD were announced from a pre-specified secondary analysis of the Phase 3 HAWK and HARRIER trials, according to a company release. Patients deemed appropriate for a 12-week treatment frequency during the first 12-week cycle after loading were able to reliably stay on that quarterly interval through week 48. "This is the first time a high level of reliability has been prospectively demonstrated for a pre-specified secondary endpoint of a 12-week dosing interval with an anti-vascular endothelial growth factor therapy in Phase 3 trials," the company press release reported. The findings showed that brolucizumab 6 mg was suitable for 12-week treatment intervals during the first 12-week cycle after the loading phase and that patients had an 87% (HAWK) and 83% (HARRIER) probability of remaining on the quarterly treatment interval through week 48. Safety was comparable to aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York), with an overall incidence of adverse events balanced across all treatment groups.

Results presented from comparison study of RGN-259 for dry eye

Results from a dry eye mouse model of RGN-259 (ReGenTree, Rockville, Maryland) and marketed products for dry eye were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting. Treatment with RGN-259 promoted recovery of mucins and goblet cells, improved corneal integrity, increased tears, and lowered inflammation in a dry eye mouse model. The RGN-259 improvements were comparable to or better than those seen with approved prescription treatments such as cyclosporine (Restasis, Allergan, Dublin, Ireland), lifitegrast (Xiidra, Shire Pharmaceuticals, Lexington, Massachusetts), and diquafosol (Diquas, Santen, Osaka, Japan). A Phase 3 clinical program from the company includes two completed studies that have shown positive clinical results for dry eye within the RGN-529 group compared with placebo and an ongoing study in patients with chronic neurotrophic keratopathy.

Rhopressa launches in the U.S.

The glaucoma medication Rhopressa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals, Durham, North Carolina) is now available in the U.S. via national and regional pharmaceutical distributors, according to a company press release. The agent was approved by the U.S. Food and Drug Administration in December.

Registration open for the 2018 Combined Ophthalmic Symposium

Registration is now open for the 2018 , August 24-26 in Austin, Texas, at the JW Marriott. The Combined Ophthalmic Symposium provides education for an entire ophthalmic practice in one weekend and offers opportunities for integrated staff development through educational tracks for ophthalmologists, optometrists, practice management staff, and nurses and technicians. In addition, there is a specialized track designed for residents and fellows.

RESEARCH BRIEFS

  • Among a large group of patients receiving treatment for endophthalmitis after an anti-vascular endothelial growth factor injection, there was no significant difference in 6-month best corrected visual acuity (BCVA) between those receiving an immediate tap and injection of intravitreal antibiotics and those having pars plana vitrectomy. Patients who were younger and had a lower IOP at presentation had better visual outcomes, reported Kunyong Xu, MD, and coresearchers. The retrospective, single-center study included 40 patients (0.016%) who had endophthalmitis within 3 weeks among a total of 258,357 intravitreal injections. There were 24 culture-positive cases, 66.7% of which were coagulase-negative Staphylococcus and 10% of which were Streptococcus species (10%). The 6-month follow-up BCVA results were significantly worse for patients who had a positive culture for Streptococcus. A higher proportion of samples were culture-positive in the pars plana vitrectomy group (90.9% vs. 48.3%, P=0.03). Initial management, symptom duration, pain, hypopyon presence, presenting BCVA, and culture status were not predictive of 6-month visual outcomes. The study is published in Ophthalmology.
  • A case report of cataract surgery in three brothers with megalocornea found that among all six eyes, postoperative corrected distance visual acuity (CDVA) was 6/6. Two eyes received a posterior chamber IOL (PC IOL) sutured to the iris with 10-0 nylon sutures. An iris-clip anterior chamber IOL (AC IOL) was used in the other four eyes. One IOL dislocated in the posterior chamber IOL group and was replaced with an iris-clip anterior chamber IOL. Among the AC IOL group, one IOL subluxated and was reenclavated. Both eyes with dislocation had a CDVA that improved to 6/6. Cataract surgery in patients with megalocornea can be challenging because of the large capsular bag in which a conventional IOL does not fit, reported Marco Messina, MD, and coauthors. The report appears in the Journal of Cataract & Refractive Surgery.
  • Contrast sensitivity and visual acuity were significantly higher 2 hours after participants in a randomized clinical trial ate a dark chocolate bar compared with a milk chocolate bar, reported Jeff Rabin, PhD, and coauthors. Dark chocolate can improve blood flow, mood, and cognition in the short term, but little is known about its effects on visual performance, the authors noted. Their trial included 30 participants without pathologic eye disease who had dark and milk chocolate in separate sessions; within-participant paired comparisons were used to assess outcomes. Small-letter contrast sensitivity was markedly higher after dark chocolate consumption versus milk chocolate, and large-letter contrast sensitivity and visual acuity were slightly higher after dark chocolate consumption. There was a significant improvement after dark chocolate consumption when composite scores combined results from all tests. Duration of these effects and real-world performance need further testing, the authors concluded. The study appears in JAMA Ophthalmology.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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