EW Weekly, October 30, 2020

FDA approves new short-term dry eye drop
Kala Pharmaceuticals announced FDA approval of EYSUVIS (loteprednol etabonate ophthalmic suspension, 0.25%), for short-term treatment of dry eye disease. According to the company’s press release, this is the first prescription drop for short-term (up to 2 weeks) dry eye signs and symptoms. The company noted that EYSUVIS uses Kala’s AMPPLIFY mucus-penetrating particle technology to enhance penetration of the medication. Launch of the product in the U.S. is expected by the end of the year.

Positive topline results for investigational presbyopia drop
Allergan announced Phase 3 GEMINI 1 and GEMINI 2 clinical trial topline results for AGN-190584 (pilocarpine 1.25%) as a treatment for presbyopia symptoms. The primary efficacy endpoint in each study was met. According to the company’s press release, in GEMINI 1, more people treated with the investigational drop gained three lines or more in low-light, high-contrast conditions with binocular distance-corrected near visual acuity at day 30, hour 3 compared to those on the vehicle drop. The GEMINI 2 trial also had more patients meeting this same endpoint without loss of CDVA of more than 5 letters with the same refraction at day 30, hour 3 compared to the control group. Patient-reported outcomes included a significant increase in reading ability and reductions of presbyopia’s impact on their daily life. There were no serious adverse treatment-related events in either study, and non-serious events that occurred in less than 3% of participants included headache, conjunctival hyperemia, blurred vision, and eye pain. The company stated that it plans on submitting its NDA to the FDA in the first half of 2021.

Positive topline results for Phase 1/2a keratoconus drop study
iVeena released topline results from its Phase 1/2a clinical trial of IVMED-80 eye drops for keratoconus. The study compared the drop against a placebo, evaluating a 6- or 16-week course of the twice-daily drop and its effect on maximum corneal keratometry and BCVA. Patient follow-up was 6 months to assess duration. Thirty-one patients, who had similar demographics, baseline Kmax, and clinical characteristics, completed follow-up. Those who received 16 weeks of IVMED-80 showed a 1.8 D mean reduction in Kmax, a statistically significant reduction in Kmax compared to the placebo group, an 11.3 letter improvement in BCVA compared to baseline, and no adverse treatment-related events. The company stated that these results currently show a faster Kmax reduction than epi-off crosslinking along with a better tolerability and safety profile. iVeena stated that IVMED-80 upregulates lysyl oxidase to induce corneal crosslinking pharmacologically.

FDA accepts NDA for severe vernal keratoconjunctivitis drug
Santen announced the FDA’s acceptance of its NDA for cyclosporine topical ophthalmic emulsion, 0.1%, for severe vernal keratoconjunctivitis. Supporting this NDA is data from a 12-month, randomized, multicenter, masked, vehicle-control, pivotal trial that had drops administered 4 times a day (high dose) or 2 times a day (low dose). Santen’s press release stated that while cyclosporine topical ophthalmic emulsion, 0.1%, is investigational for severe vernal keratoconjunctivitis in patients 4–18 years old in the U.S., it is available for this indication in 10 other countries.

IND approved for possible allergic conjunctivitis treatment
Vanda Pharmaceuticals received approval for its Investigational New Drug (IND) application from the FDA to further study VSJ-110 (cystic fibrosis transmembrane conductance regulator [CFTR] activator) as a treatment for allergic conjunctivitis. According to the company’s press release, a Phase 2 clinical trial will evaluate the anti-inflammatory and prosecretory effects. The company stated that the small-molecule compound has shown efficacy in a dry eye model and showed anti-inflammatory properties in both in vitro and in vivo assays.

Research moving forward on nitric oxide-mediated IOP-lowering agent
Nicox announced that it is moving forward with development of a new drug candidate NCX 1728, a nitric oxide (NO)-mediated IOP-lowering agent. An analog of this molecule, according to the company’s press release, showed positive results in ocular hypertensive non-human primates compared to travoprost, 0.1%. NCX 1728 is considered a new class of compounds with NO-mediated effects enhanced with concomitant PDE5 inhibition within the same molecule. According to Nicox, the role of NO in the regulation of IOP was established with the company’s lead development candidate NCX 470, a NO-donating prostaglandin analog, and its first-generation product Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%).

Research Highlights
  • Novel evidence based on objective data supports the association of near work, light intensity, and myopia. The research published in the British Journal of Ophthalmology included 86 children who wore a device that measured working distance and light levels for a week. Children with myopia were exposed to more intense light conditions for less time daily compared to non-myopic children. The research also found myopic children spend more time daily on activities that were considered near work. While this research supports the association of near work and light intensity with myopia, the researchers stated that causality and the dose-effect relationship need further study.
  • Global productivity losses due to uncorrected or under corrected presbyopia were estimated at $11 billion in 2011—increasing to $25.4 billion if it’s assumed that patients 65 and older are productive—according to a new systematic literature review. The review, in addition to evaluating productivity losses, also looked at patient perception and burden. According to the research published in Clinical Ophthalmology, patients with presbyopia reported up to a 22% decrease in quality of life scores, and up to 80% of those with uncorrected presbyopia reported difficulty in near-vision tasks. The study authors reported that these visual challenges can induce distress and low self-esteem.
  • According to a study published in Clinical Ophthalmology, it is common practice for ophthalmologists to manually center IOLs within the visual axis. Researchers sought to determine if doing this results in better postop centration. A single surgeon implanted monofocal, toric, or multifocal IOLs in 125 consecutive eyes that had either FLACS or standard phaco cataract surgery. Some IOLs were manually centered while others were not. At 4 weeks, a masked observer assessed and measured centration. Seventeen (13.6%) of all IOLs were off-centered to a minimal or mild amount at evaluation. The researchers said there was no statistically significant difference in the decentered IOLs that were manually centered intraoperatively and those that were not. Thus, they concluded that the position of the IOL “is not dependent on manual centration but rather on the design and symmetry of the IOL, as well as the integrity of the capsular bag.”

Product News
  • Bausch + Lomb introduced its SimplifEYE IOL delivery system for the enVista MX60PL and enVista toric MX60PT, which the company noted in a press release is the first pre-loaded toric IOL.
  • Visible Genomics launched a non-invasive genetic test that determines likelihood of developing AMD and/or risk of progressing to late-stage AMD if a patient already has the disease.
  • Rayner launched an updated, web-based IOL calculator, Raytrace 3.5, with improvements that include posterior corneal astigmatism, among other features.
  • Aerie and Santen Pharmaceuticals entered into a development and commercialization agreement for Rhopressa (netarsudil ophthalmic solution, 0.02%) and Rocklatan (netarsudil/latanoprost ophthalmic solution, 0.02%/0.005%) in Japan and rights for several other countries in Asia.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

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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