EyeWorld Weekly, December 10, 2021

EyeWorld Weekly, December 10, 2021

December 10, 2021 • Volume 27, Number 48

Small-aperture IOL receives approvable letter from the FDA

AcuFocus announced that it received an approvable letter from the FDA for its IC-8 small-aperture IOL. The letter, according to the company’s press release, indicates that the FDA completed its review of Premarket Approval Application for IC-8 and determined that it meets the requirements of the Food, Drug, and Cosmetic Act. AcuFocus stated that the FDA will soon be inspecting the company’s manufacturing facilities. According to the press release, AcuFocus will begin commercialization of the IOL after successful completion of these inspections and official FDA approval, which is estimated by the company to come within the second quarter of 2022.

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Topline results from Phase 2 clinical trial for intracanalicular insert for treatment of dry eye disease

Ocular Therapeutix announced topline results from its Phase 2 clinical trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for short-term treatment of signs and symptoms of dry eye. According to the company’s press release, this randomized, double-masked, vehicle-controlled, multicenter trial evaluated two formulations of OTX-DED. The trial enrolled 166 participants. The primary endpoint of statistically significant change in bulbar conjunctival hyperemia from baseline to day 15 compared to vehicle was achieved. Both the 0.2 mg study group and 0.3 mg study group showed a statistically significant difference compared to control. The study also noted improvements from baseline in visual analog scale dry eye symptoms in both study groups but reported “little separation between OTX-DED and the vehicle hydrogel insert.” The OTX-DED study formulations had a favorable safety profile and, in general, were well tolerated, according to the company’s press release.

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First in-human study to target biomarkers in the eye that identify ALS

Amydis announced a successful meeting with the FDA regarding its proposed Phase 1/2a, first in-human study that would use a small molecule tracer to detect a biomarker in the retina for ALS. The study could lead to identification of a retinal tracer to aid in early diagnosis and management of patients with ALS, according to the company. The company’s press release stated that this clinical trial will begin in the first half of 2022. According to the company, there is currently no objective diagnostic to detect, quantify, and monitor TDP43, the most defining biomarker protein of this neurodegenerative disease.

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Study provides better understanding for bilateral effect after unilateral injection of gene therapy

GenSight Biologics announced publication of a study that provides a better understanding for how unilateral ocular injection of a gene therapy resulted in bilateral improvement. According to the company’s press release, clinical studies of LUMEVOQ, a gene therapy for patients with ND4-LHON, showed improved BCVA in both eyes for patients who received unilateral injection of the therapy. The mechanism behind this contralateral therapeutic effect was studied in non-human primates. Six monkeys received a single injection of LUMEVOQ in their right eye; three monkeys were monitored for 3 months and three for 6 months. Two animals received a placebo injection and were monitored for 3 and 6 months. According to the company’s press release about the research, vector DNA was detected in all injected eyes and in five of the six non-injected eyes. The vector DNA was detected or quantified in the optic chiasm of all six animals, according to the press release. The investigators think transport of the vector DNA to the untreated eye occurs via the optic nerve and chiasm along the anterior visual pathways. This research is published in Molecular Therapy – Methods and Clinical Development.

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ASCRS news and events

  • 2022 ASCRS Annual Meeting: Tier 1 registration for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022, is open through January 12. There is also an open call for complicated case video submissions. 
  • ASCRS Winter Symposium: Registration is open for the February 10–12 Winter Symposium in Park City, Utah. The meeting focuses on the 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 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.

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Research highlights

  • A study published in JAMA Ophthalmology assessed 3,038 adults 65 years or older who were involved in the Adult Changes in Thought study, finding that those who underwent cataract surgery were at lower risk for developing dementia. The study participants were dementia free at enrollment and had biennial follow-up until they were diagnosed with dementia, the authors reported; this specific cohort analysis included those who had a cataract or glaucoma diagnosis before enrollment or during follow-up. The researchers controlled for years of education, self-reported white race, smoking history, and several other factors, concluding that cataract surgery was associated with significantly reduced risk of dementia diagnosis. Glaucoma surgery, however, did not have a significant association with dementia risk. The authors noted that this research should be validated by future studies. 
  • A population-based cohort study evaluated the ocular effects of diabetes diagnosis in childhood. The authors wrote that there is little known about the natural history of ocular sequelae in youth diagnosed with type 1 diabetes (T1D) compared to type 2 diabetes (T2D). The study used a population-based medical record review of residents within Olmsted County, Minnesota, with a diabetes diagnosis between January 1, 1970, and December 31, 2019. The records identified 1,362 individuals, 525 of whom had at least one eye examination. Ocular complications were identified in 147 of the 461 children with T1D and 17 of the 64 children with T2D. The authors found that diabetic retinopathy, proliferative diabetic retinopathy, and the need for pars plana vitrectomy occurred with a shorter duration of developing diabetes in children with T2D. Children with T2D also had nearly twice the risk of developing retinopathy compared to children with T1D. The authors suggested as frequent or more frequent ocular evaluations for pediatric patients with T2D. The research is published in JAMA Ophthalmology.

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Product news

  • Aerie Pharmaceuticals and Santen entered into an exclusive development and commercialization agreement for Rhopressa/Rhokiinsa (netarsudil ophthalmic solution) and Rocklatan/Roclanda (netarsudil and latanoprost ophthalmic solution), expanding a collaboration that now includes Europe, Commonwealth of Independent States countries, China, India, parts of Latin America, and the Oceania countries.
  • EyePoint Pharmaceuticals and ImprimisRx (a wholly owned subsidiary of Harrow Health) entered into a commercial alliance where ImprimisRx would assume responsibility for U.S. sales and marketing of EyePoint’s DEXYCU (dexamethasone intraocular suspension), which is approved in the U.S. for the treatment of postop inflammation after ocular surgery.
  • Rayner acquired ophthalmology assets from Omeros, including Omidria (ketorolac and phenylephrine injection), which is indicated for mydriasis during ocular surgery and reduction of postop pain.

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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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