- FDA approves generic Restasis
- Phase 3 trial for novel, preservative-free drug delivery platform
- Enrollment complete for Phase 3 blepharitis trial
- Enrollment complete for Phase 3 mydriasis reversal study
- Path forward for resubmission of drug-device combination product
- ‘Immunity and Inflammation in the Anterior Segment of the Eye’ report
- ASCRS news and events
February 11, 2022 • Volume 28, Number 6
FDA approves generic Restasis
The FDA announced that it has approved the first generic option for Restasis (cyclosporine ophthalmic emulsion, Allergan), in single-use vials for increased tear production in patients with ocular inflammation associated with dry eye. According to the FDA’s press release, Restasis was approved nearly 20 years ago. Generic drugs, the FDA continued, must meet the same standards for safety and efficacy as brand-name counterparts. The generic is being produced by Viatris, a subsidiary of Mylan Pharmaceuticals.
Phase 3 trial for novel, preservative-free drug delivery platform
TearClear has begun a Phase 3 trial to assess the safety and efficacy of TC-002 ophthalmic solution (TearClear preservative-free latanoprost ophthalmic solution) compared to marketed latanoprost ophthalmic solution. According to the company’s press release, TearClear’s drug delivery platform ensures that topical drugs are preserved in a multidose bottle but are delivered in a preservative-free format, which is more friendly to the ocular surface.
Enrollment complete for Phase 3 blepharitis trial
Tarsus Pharmaceuticals completed enrollment of 408 patients for its Phase 3 Saturn-2 trial, the second of its pivotal Phase 3 trials, for TP-03 (lotilaner ophthalmic solution) for treatment of Demodex blepharitis. Topline results, according to the company, are expected in April, with an NDA filing anticipated later in the year.
Enrollment complete for Phase 3 mydriasis reversal study
Ocuphire Pharma announced that it completed enrollment for its Phase 3 MIRA-3 study set to evaluate the safety and efficacy of Nyxol (phentolamine), a topical, investigational drop for the reversal of pharmacologically induced mydriasis. Nearly 368 patients, 12 years and older, were enrolled at 16 U.S. centers for this randomized, double-masked, placebo-controlled pivotal trial. Topline results are expected by the end of the first quarter of 2022 with submission of an NDA to the FDA for Nyxol in late 2022, according to the company’s press release.
Path forward for resubmission of drug-device combination product
Eyenovia announced that it had a Type A meeting with the FDA for MydCombi, a tropicamide/phenylephrine pupil dilation product dispensed with the company’s Optejet device. This combination had been reclassified by the FDA in October as a drug-device combination product. According to the company’s press release, this latest meeting put Eyenovia on the path forward to NDA resubmission. The company stated that the FDA requested additional testing for the dispenser, but no additional studies were required for MydCombi.
‘Immunity and Inflammation in the Anterior Segment of the Eye’ report
The National Eye Institute Anterior Segment Initiative hosted a workshop and produced a report on “Immunity and Inflammation in the Anterior Segment of the Eye.” This workshop, according to a news release from the National Eye Institute, identified gaps in knowledge, barriers to development of new therapies, and areas for future research.
ASCRS news and events
- 2022 ASCRS Annual Meeting: Browse the recently released Preview Program for the ASCRS Annual Meeting in Washington, D.C., April 22–26. There is also an open call for complicated case video submissions.
- Beyond 20/20: Beyond 20/20:An ASCRS Series in Modern Refractive Surgery and Presbyopia Therapy is a new, four-part educational series sponsored by the Refractive Clinical Committee that features CME and non-CME components. Learn more about the series and register here.
- Eyecelerator@ASCRS: Eyecelerator@ASCRS is welcoming the Winning Pitch Challenge to its program, taking place April 21 ahead of the ASCRS Annual Meeting in Washington, D.C. The Winning Pitch Challenge supports physician entrepreneurs and is accepting submissions now. Learn more about the challenge, the submission process, and deadlines here.
Research highlights
- The results from the FDA clinical trial for the CUSTOMFLEX Artificial Iris (HumanOptics) for treatment of congenital and acquired iris defects were published in the journal Ophthalmology. The devices were implanted between November 2013 and December 2017 with one of four different surgical techniques used depending on pathology. Patients were evaluated out to 12 months postop. According to the paper, there was a 59.7% reduction in daytime light sensitivity, a 41.5% reduction in nighttime light sensitivity, and a 48.5% reduction in severe nighttime glare sensitivity. More than 90% of patients reported an improvement in cosmesis. There was also no loss of CDVA greater than 2 lines related to the use of the artificial iris. Median endothelial cell loss was 5.3% at 6 months postop and 7.2% at 12 months postop. The authors stated that this artificial iris “surpassed all key safety endpoints for adverse events related to the device, IOL, or implant surgery.” All key efficacy endpoints were met. “The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects,” the authors concluded.
- A parallel-arm, single-masked, randomized, controlled trial evaluated the effect of “mindfulness-based stress reduction (MBSR)” on IOP in patients with ocular hypertension. Sixty patients with an IOP between 21–30 mm Hg were included in the study; 30 had 6 weeks of a 1-hour daily MBSR session (group 1) and 30 were waitlisted and kept for follow-up (group 2). At 6 weeks, there was a significant decrease in IOP in group 1 (23.05±1.17 mm Hg to 19.15±1.45 mm Hg) compared to group 2 (22.55±0.98 mm Hg to 22.37±1.07 mm Hg). The mean change in IOP was significantly greater in group 1 as well. There was a decrease in diurnal IOP fluctuation in group 1 and a significant improvement in vessel perfusion, vessel density, and flux index on OCT-A. Serum cortisol levels were decreased in group 1. With these findings, the authors concluded that MBSR could be considered a potential treatment for the management of ocular hypertension. This research was published in the American Journal of Ophthalmology.
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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