- Survey: 96% of ophthalmologists vaccinated against COVID-19
- Phase 2b/3 results from trial for Demodex blepharitis
- Data from ongoing Phase 2a study of therapy for geographic atrophy
- First patient enrolled in Phase 2 study of nasal spray for neurotrophic keratopathy
- Next ASCRS Journal Club on July 8
June 25, 2021 • Volume 27, Number 25
Survey: 96% of ophthalmologists vaccinated against COVID-19
The American Academy of Ophthalmology (AAO) surveyed its members and found that 96% of respondents said they received one of the COVID-19 vaccine options. According to a press release from AAO, 871 ophthalmologists completed its online survey, which was conducted between May 14–June 8, revealing that a strong percentage of this medical specialty is fully vaccinated. The survey also asked about staff who have patient contact, finding that 78% of respondents said 75% or more of its staff who are patient facing were vaccinated against COVID-19. The American Medical Association also recently surveyed practicing physicians in general and found 96% in this broader category was fully vaccinated.
Phase 2b/3 results from trial for Demodex blepharitis
Tarsus Pharmaceuticals announced that it met primary and secondary endpoints in its pivotal Phase 2b/3 Saturn-1 trial evaluating TP-03 (lotilaner ophthalmic solution, 0.25%) in patients with Demodex blepharitis. There was complete collarette cure at day 43 in patients treated with this compound, compared to vehicle. Mites were eradicated and composite cure, based on complete collarette and erythema cure, at day 43 was also achieved, according to the press release. The company reported that TP-03 had a similar safety profile as the vehicle with no treatment-related discontinuations. Tarsus plans to have topline results from Saturn-2, its second pivotal trial, in the first quarter of 2022. If results are similar to Saturn-1, the company stated that it could support an NDA submission in 2022.
Data from ongoing Phase 2a study of therapy for geographic atrophy
Gemini Therapeutics announced data from its ongoing Phase 2a study of its recombinant human complement factor H (GEM103) in patients with geographic atrophy secondary to dry AMD. The ReGAtta dose escalation trial, thus far, has found continued tolerance of the therapy, which is administered intravitreally, and biologic activity of GEM103 regulating the complement, in addition to support for dosing every other month. No serious adverse events were reported, but out of 390 injections among the study group that included 62 patients, 16 patients (26%) experienced an adverse event (12 of which were conjunctival hemorrhage related to the injection). According to the company’s press release, visual acuity remained stable throughout the study period, and progression of geographic atrophy at 3 and 6 months in the study eye compared to fellow eyes that met inclusion criteria was “statistically indistinguishable.”
First patient enrolled in Phase 2 study of nasal spray for neurotrophic keratopathy
Oyster Point Pharma announced that the first patient has been enrolled in its Phase 2 OLYMPIA trial of OC-01 (varenicline), a nasal spray, for the treatment of stage 1 neurotrophic keratopathy classified with the Mackie system. This multicenter, randomized, double-masked, placebo-controlled trial will evaluate about 100 patients across 18 sites in the U.S. The nasal spray will be administered 3 times and compared to vehicle (also administered as a spray). According to the company’s press release, the primary endpoint is percentage of study participants who achieve complete resolution of fluorescein corneal staining at day 56. The company described OC-01 as a preservative-free cholinergic agonist that is meant to activate the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear production. Oyster Point filed an NDA for OC-01 for signs and symptoms of dry eye disease with the FDA in December 2020 and has a PDUFA target action date for this indication in October 2021.
Next ASCRS Journal Club on July 8
Plan to join ASCRS’ interactive Journal Club on Thursday, July 8, from 9:00–10:00 p.m. ET for another session in this monthly series in which a panel of experts will discuss two pre-selected manuscripts from the Journal of Cataract & Refractive Surgery. Nick Mamalis, MD, and Leela Raju, MD, co-moderate these free CME sessions, open to all ASCRS members. The July session will feature Jake McMillin, MD, and Hetal Ray, MD, as discussants, and M. Bowes Hamill, MD, Nathan Radcliffe, MD, and Karolinne Rocha, MD, PhD, as panelists.
Research highlights
- Research published in the American Journal of Ophthalmology compared the long-term results of DSAEK and DMEK in fellow eyes that had Fuchs. Sixty-four patients (128 eyes) were included in the two-centered, retrospective case series. DSAEK was conducted in the first eye followed by DMEK in the second. The main outcome was BSCVA and how long it took to achieve BSCVA. According to the research, both procedures achieved comparable BSCVA, but DMEK procedures achieved it faster (277 days with DMEK vs. 490 days with DSAEK). According to the research, 22 patients preferred the DMEK procedure, 17 preferred DSAEK, and 25 patients did not have a preference.
- A pilot study evaluated the safety and efficacy of a single dose of 5% povidone-iodine (PVP-I) compared to control (artificial tears) against adenoviral conjunctivitis. The study took place at nine U.S. clinics and included patients with presumed adenoviral conjunctivitis (four or more days of symptoms and a positive test). Fifty-six patients (28 of whom had detectable viral titers at baseline) were randomized to receive either the PVP-I treatment or control. By day 4, 2.5%±2.7% of those in the PVP-I group had viral titers compared to 14.4%±10.5% in the artificial tears group. Participant-reported symptoms (tearing, lid swelling, and redness) and clinician-graded signs (mucoid discharge, bulbar redness, and bulbar edema) were lower in the PVP-I group compared to control at day 4. After day 4, signs and symptoms decreased in both groups and there was no difference between the groups. With these findings, the investigators concluded a dose of 5% PVP-I could speed improvement of clinical signs and symptoms in patients with adenoviral conjunctivitis. The research is 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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