EW Weekly, March 29, 2019

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March 29, 2019
Volume 24 , Number 12

Top-line results announced from Phase 3 ALLEVIATE trial for allergic conjunctivitis

Aldeyra Therapeutics announced top-line results from the Phase 3 ALLEVIATE trial for 0.25% and 0.5% reproxalap topical ophthalmic solution in allergic conjunctivitis patients. The clinical trial met its primary and secondary endpoints for both concentrations, according to a company press release. The double-masked, randomized, vehicle-controlled, multicenter, parallel-group conjunctival allergen challenge trial focused on the efficacy and safety of both concentrations compared with vehicle in 318 patients with seasonal allergic conjunctivitis. Both concentrations showed a statistically significant reduction of ocular itching relative to patients treated with vehicle. The concentrations also showed an anti-inflammatory profile distinct from standard-of-care antihistamine therapy and supported a differentiated mechanism of action, the company reported. Aldeyra leaders are conducting clinical method development studies now and plan to meet with regulatory authorities in the second half of this year to discuss a potential submission of a New Drug Application to the U.S. FDA.

Phase 2 trial of NCX 4251 for blepharitis begins

A Phase 2 clinical trial to evaluate NCX 4251 (fluticasone propionate nanocrystals, Nicox) for blepharitis has begun. The multicenter, randomized, double-masked, placebo-controlled, dose-escalation trial will focus on the safety and tolerability of the agent compared to placebo in an estimated 30 patients from around the U.S., according to a company press release. The trial's primary objective is to select the dose(s) of NCX 4251 to advance to the next development stage, which will be a larger Phase 2b trial.

Phase 2b study for CSF-1 to treat presbyopia begins

A Phase 2b clinical trial to evaluate the eye drop CSF-1 (Orasis Pharmaceuticals) to treat presbyopia is underway, according to a company press release. The multicenter, double-masked trial is enrolling 150 participants in the U.S. with presbyopia to evaluate the efficacy and safety of CSF-1, which is described as an alternative to reading glasses. All study sites are actively recruiting participants with presbyopia between the ages of 45 and 64.

Clinical trial for retinitis pigmentosa treatment advances

Dosing of a second cohort of three Phase 2 subjects in a trial of an hRPC cell therapy candidate (ReNeuron) has begun, according to a company press release. The next dose cohort includes patients with a greater baseline level of visual acuity than those treated so far in the study. The company previously reported that the three subjects in the first cohort of the Phase 2 study had rapid and significant improvement in vision that was equivalent to reading an additional three lines of five letters on the EDTRS eye chart. ReNeuron expects to report further short-term results from their Phase 1 and 2 studies by the middle of the year.

Adhesive gel that can seal corneal cuts and ulcers could help repair injuries

An adhesive gel with light-activated chemicals that can seal corneal cuts or ulcers could be used in the future to repair injuries. The preclinical findings with the GelCORE (gel for corneal regeneration) were published earlier this month in Science Advances. "Our hope is that this biomaterial could fill a major gap in technology available to treat corneal injuries," said Reza Dana, MD, corresponding author. GelCORE is made of chemically modified gelatin and photoinitiators activated by a short-time blue light exposure. The material hardens when exposed to light and over time, corneal cells gradually grow and merge with the material. Trials in humans are tentatively slated for a year from now.

Alcon spin-off by Novartis planned for April

Completion of the spin-off of Alcon by Novartis is expected on April 9, according to a Novartis press release. Shares in Alcon are expected to be listed and traded on the SIX Swiss Exchange and the New York Stock Exchange under the ticker symbol ALC.

ASCRS ASOA Annual Meeting Tier Two registration deadline April 3

Excitement is building for the 2019 ASCRS ASOA Annual Meeting,* May 3-7, in San Diego. Register by the Tier Two registration deadline, this Wednesday, April 3, to take advantage of the best rates. Browse the Real-Time Program for updated program information. Make the most of the Annual Meeting by selecting the "ASCRS ASOA Annual Meeting + ASCRS Subspecialty Day" category,** which provides attendees with full access to ASCRS programming including instructional courses, symposia, and Friday's ASCRS Subspecialty Day programming.

*Must have current membership to attend the Annual Meeting
**Does not include Skills Transfer Labs

Register now: FDA and ophthalmic community workshop on laser-based imaging

On April 8 from 8:00 a.m. to 4:30 p.m. ET, join ASCRS, the FDA, and ophthalmic community at the Tommy Douglas Conference Center in Silver Spring, Maryland, for a 1-day workshop that will focus on the latest trends and enhancements in ophthalmic laser-based imaging modalities, including: optical coherence tomography and adaptive optics, regulatory and reimbursement considerations, and new topics of interest such as the Medical Device Development Tools program and the emerging role of artificial intelligence. Registration is required to attend. ASCRS members will receive a discounted rate of $295 (in-person) and $275 (webcast). To register for the public workshop, visit Forum on Laser-Based Imaging. If you have any questions or need help registering, contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org.

Research briefs

Research briefs
  • In an assessment with 244 patients, Brian Pall, OD, and researchers demonstrated the efficacy of contact lens delivery of a therapeutic for ocular allergy. The contact lens contained the antihistamine ketotifen and was tested in two parallel, conjunctival allergen challenge-based trials. Both multicenter, randomized, placebo-controlled trials used etafilcon A test lenses with 0.019 mg ketotifen or etafilcon A control lenses with no ketotifen. The primary endpoint was ocular itching measured with a 0 to 4 scale with half-unit steps. Mean itching scores were lower for test lens eyes compared to controls. The mean differences in itching were clinically and statistically significant. The research is published in Cornea.
  • Topography-guided custom treatment led to better achieved visual acuity than the preop corrected distance visual acuity (CDVA) in more than 25% of eyes in a retrospective case series, reported Vinicius De Stefano, MD, and coresearchers. Their research focused on planning strategies for eyes that gained one or more lines of CDVA after topography-guided custom treatment. Among the 256 eyes included in the study, all had topography-guided treatment by the same surgeon. The uncorrected distance visual acuity was 20/20 or better in 95.7% of eyes at 3 months and 20/15 or better in 81.4% of eyes. Nearly 26% of eyes gained one or more lines of CDVA. Tomography and wavefront aberrometry helped to select eyes that would achieve optimum visual outcomes. The study is published in the Journal of Cataract & Refractive Surgery.
Product News
  • The A/B/S Ultrasound Platform ABSolu (Quantel Medical) has received approval from the U.S. FDA.

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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