- Topline data from Phase 3 trial of presbyopia-correcting drop
- FDA gives 510(K) approval to updated neuromodulation therapy for increased tear production
- Enrollment complete for Phase 3 trial of reproxalap
- DME trial to focus on underrepresented patient populations
- BLA submitted to FDA for wet AMD therapy
- Companies collaborate to further develop gene therapy for retinal disease
- ASCRS news and events
April 8, 2022 • Volume 28, Number 14
Topline data from Phase 3 trial of presbyopia-correcting drop
Topline data from Allergan’s Phase 3 VIRGO trial evaluating twice-daily dosing of VUITY, pilocarpine HCl ophthalmic solution, for the temporary treatment of presbyopia showed that primary endpoints were met. A similar safety profile was observed as with the currently approved once-daily administration. According to the company’s press release, near vision was improved without a compromise in distance vision at day 14, hour 9 in the trial. This data will supplement an NDA submission to the FDA in the second quarter of the year for optional twice-daily dosing. The trial included 230 participants 40–55 years old with presbyopia. They were randomized to receive placebo or VUITY, with two drops in each eye per day for 14 days. The second drop was instilled 6 hours after the first.
FDA gives 510(K) approval to updated neuromodulation therapy for increased tear production
Olympic Ophthalmics received FDA 510(K) approval for its second-generation iTEAR100 device, which the company described as a prescription neuromodulation therapy to acutely increase tear production in patients over a 30-day period of time. This device has smartphone connectivity, offering telehealth opportunities, improved longevity, and with an easily controllable design, according to the company. iTEAR100 is the only FDA-approved at-home prescription medical device to increase natural tear production, the company said. The company currently has three ongoing trials to 1) evaluate iTEAR100 as a first-line treatment in patients with newly diagnosed dry eye disease; 2) evaluate the benefits of the telehealth features; and 3) seek a possible label expansion with research to optimize basal tear secretion vs. reflex tearing.
Enrollment complete for Phase 3 trial of reproxalap
Aldeyra Therapeutics announced that it has completed enrollment for its TRANQUILITY-2 trial, a Phase 3 clinical trial, of reproxalap ophthalmic solution, for treatment of dry eye disease. Topline results are expected in the second quarter of 2022. The study enrolled 361 patients who were randomized to receive reproxalap or vehicle over 2 days—four doses on the first day followed by Schirmer testing at baseline and after the fourth dose. On the second day, a dose was administered just before the patient was in a dry eye chamber and at 45 minutes (out of 90 total minutes) within the low-humidity, high-airflow chamber where they performed visual tasks, according to the press release. Primary endpoints are Schirmer tests on the first day and ocular redness on the second day.
DME trial to focus on underrepresented patient populations
Genentech is beginning the Elevatum trial with its Vabysmo (faricimab-svoa) therapy for diabetic macular edema (DME), focusing on historically underrepresented patient populations. The company’s notice about the study stated that Black, African American, Hispanic, Latin American, and Indigenous people are disproportionately affected by diabetes and are at higher risk of developing DME. With this risk and a “historical industry-wide lack of diversity in clinical trials,” the company stated that it designed the Elevatum trial to specifically focus on the outcomes of this therapy in these underrepresented populations with the goal of ultimately improving the standard of care for all patients.
BLA submitted to FDA for wet AMD therapy
Outlook Therapeutics submitted a Biologics License Application (BLA) to the FDA for ONS-5010 (bevacizumab-vikg), an investigational therapy for treatment of wet AMD. If approved, the company would market it as LYTENAVA and stated that it “could replace the current practice of using unapproved IV bevacizumab sourced from compounding pharmacies for treatment of wet AMD.” Potential marketing approval would be anticipated for late 2022 or early 2023.
Companies collaborate to further develop gene therapy for retinal disease
ViGeneron and Regeneron Pharmaceuticals announced their strategic collaboration that will further develop and commercialize a gene therapy based on ViGeneron’s novel adeno-associated virus vectors for treatment of an inherited retinal disease. The company’s press release stated that the companies will collaborate on creation and validation of the vgAAV-based candidates, and Regeneron will have the exclusive license to develop, commercialize, and manufacture the vgAAV-based product for the target. The company stated that ViGeneron’s vgAAV vector is designed to overcome limitations of other AAV-based gene therapies.
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:Watch the latest episode of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, with guest Amar Agarwal, MD.
Research highlights
- A retrospective comparative study published in the journal Cornea sought to analyze the role of corneal epithelial thickness mapping with SD-OCT in diagnosing ocular surface disorders (OSDs) combined with quantitative analysis of epithelial thickness (ET). The study included 303 eyes with OSD and 55 normal eyes that served as controls. The epithelial thickness maps were classified as normal, doughnut, spoke-wheel, localized/diffuse, and thinning/thickening. The results found that full agreement in classification among three readers occurred in 75.4–99.4% of cases. The main OSD features were: keratoconus (135 eyes) with a doughnut pattern and a maximum-minimum ET of ≥ 13 μm; limbal deficiency (56 eyes) with a spoke-wheel pattern and max-min ET of ≥ 14 μm; EBMD (55 eyes) with inferior thickening patterns and central ET of >56 μm; dry eye (21 eyes) with superior thinning patterns and a minimum ET of ≤ 44 μm; pterygium (10 eyes) with nasal thickening and nasal ET of >56 μm; and in situ carcinoma (11 eyes) with a max ET of >60 μm and an ET SD of >5 μm. The authors concluded that epithelial map pattern recognition combined with quantitative analysis of epithelial thickness is relevant for diagnosing OSD and distinguishing various OSDs. They stated that deep learning of a big dataset could lead to a fully automated diagnostic system for these disorders.
- A national, non-interventional, cross-sectional, mixed-methods survey analyzed the potential impacts on cataract surgery candidates’ expectations and behaviors. The paper published in Clinical Ophthalmology included 278 survey participants who were 65 years or older and who had no history of cataract surgery. Twenty percent of participants said they wanted to have cataract surgery and 8% said they wanted to have cataract surgery right away. The authors found that 1 out of 3 survey participants was fearful of the procedure, which was correlated with an intention to delay the surgery for as long as possible. Less than 2% of participants said their doctors recommended at-home strategies to preoperatively mitigate risks of OSD, but most said they would use a preop kit if they were given one (87%), asked to buy one (83%), or asked to get one online (71%). “These findings negate the popular assumption that patients are in a hurry to have their cataract surgery right away and, therefore, may resist physician recommendations to address ocular surface disease preoperatively,” the authors concluded.
Product news
- Alcon launched the Systane iLux2 Thermal Pulsation System, with imaging technology to view meibomian glands and the treatment procedure and customizable heat and compression features.
- Beovu (brolucizumab, Novartis) received European Commission approval for treatment of diabetic macular edema.
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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