- Launch of Phase 3 clinical trial for presbyopia drop candidate
- Topline results for investigational dry eye therapy
- Positive findings for photobiomodulation dry AMD treatment
- Enrollment completed for investigational oral diabetic retinopathy therapy
- Longer-term data from Phase 3 studies evaluating geographic atrophy therapy released
- Orphan drug designation granted to investigational retinitis pigmentosa treatment
- ASCRS news and events
March 25, 2022 • Volume 28, Number 12
Launch of Phase 3 clinical trial for presbyopia drop candidate
Visus Therapeutics launched a Phase 3 pivotal trial for BRIMOCHOL PF (carbachol/brimonidine tartrate), a preservative-free topical ophthalmic solution for the temporary treatment of presbyopia. According to the company, this is the first of two Phase 3 trials, both of which are double-masked, randomized, and multicenter to evaluate safety and efficacy of the therapy in emmetropic phakic and pseudophakic presbyopic patients. The primary efficacy endpoint will be the percentage of patients who gain three lines of binocular near visual acuity without losing one line of distance. Results are expected in the fourth quarter of this year. The studies will evaluate a fixed-dose combination of carbachol and brimonidine tartrate and a proprietary formulation of carbachol monotherapy, according to the company’s press release.
Topline results for investigational dry eye therapy
VivaVision Biotech announced positive topline results from its Phase 2 clinical trial of VVN001 (a second-generation LFA-1 inhibitor) for dry eye disease. The study was randomized, double masked, vehicle controlled, and conducted at 14 U.S. centers. It evaluated safety and efficacy of two concentrations of the drug—VVN001 5% and VVN001 1%—against vehicle. Participants were treated twice daily over 84 days. According to the company, subjects in all groups, including vehicle, improved. The improvement was greater in the 5% treatment group compared to vehicle. Total corneal staining saw a statically and clinically significant improvement and a dose and treatment duration-related improvement, the press release reported. The company stated that both concentrations were safe and well tolerated. The results from this study will inform future Phase 3 trials.
Positive findings for photobiomodulation dry AMD treatment
LumiThera released results from the LIGHTSITE III multicenter clinical trial that evaluated its photobiomodulation treatment in patients with dry AMD. Patients received treatment with the Valeda Light Delivery System every 4 months for 24 months. The analysis included 91 eyes in the treatment group and 54 eyes in the control group and showed a statistically significant improvement in BCVA at 13 months in the treatment group. There was also a sustained mean 5.5 letter increase in ETDRS letter score in the treatment group, according to the company’s press release. The study will continue to treat and follow subjects out to the 24-month mark. The Valeda Light Delivery System has the CE mark but is not yet FDA approved.
Enrollment completed for investigational oral diabetic retinopathy therapy
More than 100 patients have been enrolled in a Phase 2b trial being conducted by Ocuphire Pharma to evaluate the efficacy and safety of APX3330 for treatment of diabetic retinopathy. According to the company’s press release, the study is being conducted at 25 U.S. sites and enrolled patients with moderately severe to severe non-proliferative diabetic retinopathy or mild proliferative diabetic retinopathy. Anti-VEGF injections are among the most common currently approved treatments. Ocuphire is investigating APX3330 as a possible oral therapy for diabetic retinopathy or diabetic macular edema. According to the company’s press release, if approved, a systemic treatment such as this could improve dosing convenience or compliance issues associated with frequent anti-VEGF injections. Study participants will receive 600 mg APX3300 or placebo daily over 24 weeks. The company stated that the primary endpoint is a responder analysis that evaluates the percentage of subjects with a two or more step improvement on the Diabetic Retinopathy Severity Scale score.
Longer-term data from Phase 3 studies evaluating geographic atrophy therapy released
Apellis Pharmaceuticals announced longer-term data from its two Phase 2 studies evaluating intravitreal pegcetacoplan. The data showed that the treatment continued to reduce geographic atrophy lesion growth and demonstrated favorable safety at 18 months for treatment of geographic atrophy secondary to AMD. The company plans to submit a New Drug Application to the FDA in the second quarter of this year.
Orphan drug designation granted to investigational retinitis pigmentosa treatment
Kiora Pharmaceuticals was granted an orphan drug designation by the FDA for its investigational KIO-301 treatment for retinitis pigmentosa. Clinical trials for KIO-301 are expected to begin in the third quarter of this year. The company described KIO-301 (benzyl ethyl aminoazobenzene quaternary ammonium) as “a visible light-sensitive small molecule that acts as a reversible ‘photoswitch,’ specifically designed to restore the eyes’ ability to perceive and interpret light in visually impaired patients.”
ASCRS news and events
- 2022 ASCRS Annual Meeting: Register for the ASCRS Annual Meeting in Washington, D.C., April 22–26. Read this Q&A with EyeWorld Chief Medical Editor Eric Donnenfeld, MD, and ASCRS Program Chair Edward Holland, MD.
- Eyecelerator@ASCRS: Registration is open for Eyecelerator@ASCRS, taking place April 21 ahead of the ASCRS Annual Meeting in Washington, D.C.
- ASCRS Grand Rounds: The first ASCRS Grand Rounds of 2022, presented by NYU Langone Department of Ophthalmology, is available on demand.
- Ophthalmology Quicksand Chronicles: The popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, welcomed guest Amar Agarwal, MD, to kick off Season 2. Watch the podcast here.
Research highlights
- Research published in the journal Ophthalmology evaluated corneal endothelial cell density (ECD) loss following glaucoma surgery with or without cataract surgery. The authors conducted a literature review and included 39 studies in quantitative analysis. Overall, the authors concluded that there is low certainty evidence suggesting that glaucoma surgery with long-term implants has greater ECD loss than glaucoma filtration surgery without implants. “The results of this review support long-term follow-up (beyond 36 months) to assess ECD loss and corneal decompensation following implantation of glaucoma drainage implants,” the authors concluded.
- Corneal sensation and other ocular surface symptoms were evaluated among patients who had multiple intravitreal anti-VEGF injections for AMD and DME. The study published in Cornea included 40 patients (20 treated with anti-VEGF therapy for AMD and 20 with DME) and 30 healthy controls. In vivo corneal confocal microscopy, corneal sensitivity measurements, non-invasive tear breakup time, and OSDI measurements were performed. Corneal nerve fiber density, nerve branch density, length of nerve fibers, and other metrics were evaluated with automatic digital analysis. Corneal nerve fiber density, nerve branch density, total length of nerve fibers, and corneal nerve fiber fractal dimension and corneal sensitivity were significantly decreased in AMD and DME groups compared to control. Corneal nerve fiber width and OSDI scores were increased in AMD and DME groups compared to control. Corneal sensitivity was decreased more in patients with DME than those with AMD. Tear breakup time was not different, the authors reported.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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