- FDA clearance for viscodelivery system
- FDA approves IND application for immunomodulatory agent for dry eye
- Phase 2b results for sustained-release, IOP-lowering implant
- Positive topline Phase 2 results for investigational dry eye drug
- Phase 2 trials begin for two transdermal drug formulations
- Second pivotal trial begins for wet AMD gene therapy
- Alcon completes acquisition of Ivantis
- ASCRS news and events
January 14, 2022 • Volume 27, Number 2
FDA clearance for viscodelivery system
The FDA issued 510(k) clearance to Glaukos’ iPRIME Viscodelivery System, which the company described as a sterile, single-use, minimally invasive device that delivers viscoelastic during ophthalmic surgery.
FDA approves IND application for immunomodulatory agent for dry eye
Aramis Biosciences announced FDA clearance of its IND application for A197, a novel immunomodulatory agent for the treatment of dry eye disease. The company will now be able to proceed with its Phase 2 proof-of-concept trial with the agent, which it thinks targets the immunopathogenesis of dry eye.
Phase 2b results for sustained-release, IOP-lowering implant
Glaukos announced 36-month results from its Phase 2b clinical trial of iDose TR for sustained release of travoprost for IOP lowering. According to the company’s press release, iDose TR (still under investigation) is designed to release the prostaglandin analog continuously for a year, at which point it could be replaced with another implant. This analysis showed well-controlled IOP lowering with the same or fewer topical glaucoma medications at a 36-month screening in 70% and 68% of study participants who received fast- and slow-release iDose TR, respectively, compared to 46% in the topical timolol control arm. The company reported an IOP reduction from baseline of 8.3 mm Hg and 8.5 mm Hg, in the fast- and slow-release iDose TR groups, respectively (8.2 mm Hg in the timolol control arm). Patient enrollment and randomization for the Phase 3 clinical program for iDose is complete with 12-month results expected later this year. The company plans to submit an NDA in 2022 and estimates possible FDA approval for iDose TR in 2023.
Positive topline Phase 2 results for investigational dry eye drug
Positive Phase 2 results were announced by Aldeyra Therapeutics for reproxalap ophthalmic solution 0.25%. The study compared ocular discomfort and itching symptom scores of reproxalap to Xiidra (lifitegrast ophthalmic solution 5%, Novartis). Aldeyra reported statistically lower discomfort scores in the study participants who received reproxalap compared to Xiidra. According to the company’s press release, this double-masked, crossover, single-center clinical trial included 56 patients with dry eye disease. A single dose of reproxalap or Xiidra was administered to each of the eyes of the participants 5 minutes prior to dry eye chamber exposure for 45 minutes. There were safety signals or treatment-related discontinuations related to the drug. The most common adverse event in both treatment arms was mild instillation site discomfort, according to the company.
Phase 2 trials begin for two transdermal drug formulations
The first patients were enrolled in two Phase 2 trials that Glaukos is conducting with its cream-based, transdermal iLution platform. One trial is evaluating the drug delivery system for dry eye disease and another for presbyopia therapy. According to the company’s press releases, the cream is placed on the outside of the eyelid for transdermal delivery of the therapy. In both trials, the active therapeutic in GLK-301 (for the dry eye trial) and GLK-302 (for the presbyopia trial) is pilocarpine. Both trials are multicentered, randomized, double-masked, and placebo controlled. The trial for patients with dry eye disease will assess signs and symptoms of dry eye as endpoints, while the presbyopia trial will assess improvement in mesopic, high-contrast, binocular distance-corrected near visual acuity and maintenance of binocular best-corrected distance visual acuity.
Second pivotal trial begins for wet AMD gene therapy
Regenxbio has begun the second of its two Phase 3 pivotal trials evaluating the safety and efficacy of RGX-314, subretinal delivery of a one-time gene therapy for treatment of wet AMD. This trial is multicenter, randomized, and active-controlled, evaluating the safety and efficacy of two dose arms of the gene therapy compared to intravitreal injections of aflibercept. The primary endpoint is non-inferiority to aflibercept based on change from baseline BCVA at 1 year. The company reported that it plans to submit a biologics license application (BLA) to the FDA in 2024 based on these two trials.
Alcon completes acquisition of Ivantis
Alcon announced that it has now fully acquired Ivantis, the developer of the Hydrus Microstent. According to Alcon’s press release, the company plans to bring the Hydrus Microstent to more international markets and to prioritize evidence-based research. Alcon’s press release noted its intent to pursue research on standalone surgery with Hydrus in the U.S. with clinical trials underway.
ASCRS news and events
- Meet ASCRS’ new head of Government Relations: Brad Gruehn joined ASCRS as the Chief of Government Relations this month. Mr. Gruehn brings nearly 30 years of political and legislative experience to ASCRS, most recently serving as the Congressional Affairs Director for the American College of Emergency Physicians where he led several campaigns to enact legislation that benefited those members and their patients.
- 2022 ASCRS Annual Meeting: Tier 1 pricing for registration for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022, has been extended through January 23. There is also an open call for complicated case video submissions for two ASCRS symposia.
- ASCRS Winter Symposium: Registration is open for the Winter Symposium in Park City, Utah, February 10–12. The meeting focuses on innovative techniques and controversies in anterior segment ophthalmology.
- Beyond 20/20: Beyond 20/20: An ASCRS Series in Modern Refractive Surgery and Presbyopia Therapy is a new, four-part educational program sponsored by the Refractive Clinical Committee that features CME and non-CME components. Learn more about the program and register here.
Research highlights
- A survey was sent to more than 200 ophthalmologists (in cornea, glaucoma, retina, and comprehensive specialties) to collect data to assess musculoskeletal complaints and factors that could be related to symptom severity. According to the paper published in Clinical Ophthalmology, 144 ophthalmologists responded to at least part of the survey, with pain being reported in 81% of respondents. Neck, low back, and shoulders were cited as commonly affected areas. Minimal disability related to spinal issues was found. The paper reported that higher job stress ratings seemed to correspond with more frequent pain attacks and higher total disability index scores. There was also greater difficulty with some clinic, laser, and surgical tasks in those who had higher disability index scores and more pain locations. Most respondents (94.2%) were interested in learning more about improved ergonomics, according to the paper.
- While much is known about the incidence and progression of childhood myopia, the 8-year Raine Study published in JAMA Ophthalmology gives insights on incidence and progression in early adulthood. The study had baseline data (at 20 years old) and follow-up data (at 28 years old) on 701 participants. According to the paper, 8-year myopia and high myopia incidence were 14% and 0.7%, respectively. A myopic shift of 0.5 D or more was observed in 261 participants. The study also noted that rates of progression and axial elongation were faster in female participants and those with parental myopia. Education was not associated with myopia incidence or progression in this group. The authors concluded that myopia progression continues at a lower rate in early adulthood, compared to childhood. They suggested the possibility of protective effects of increased outdoor time in early adulthood.
Product news
- Rayner announced the availability of its first blue-light filtering IOL, the RayOne Hydrophobic BLF.
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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