- Study: Standalone trabeculotomy/viscodilation 24-month outcomes
- Proof of concept for dropless immunosuppression after PK
- Topline Phase 2 data for high-dose aflibercept in wet AMD
- Companies enter licensing agreement for investigational ophthalmic therapies
- ASCRS news and events
August 27, 2021 • Volume 27, Number 34
Study: Standalone trabeculotomy/viscodilation 24-month outcomes
Sight Sciences announced 24-month outcomes of standalone use of its OMNI Surgical System, which performs trabeculotomy/viscodilation, in patients with mild to moderate open-angle glaucoma. According to the press release about the study published in the journal Clinical Ophthalmology, 38 eyes of 27 subjects were included. The paper put mean baseline IOP at 24.6 mm Hg; mean IOP postop at 24 months was 14.9 mm Hg. According to the authors, 100% of eyes achieved an IOP reduction of at least 20%. Mean medication use at baseline was 1.9; at 24 months postop, mean medication use was 0.5. The authors reported that 84.6% of eyes were on less than 1 medication, and 57.7% were medication-free after the procedure. The authors concluded that the OMNI Surgical System “provides clinically relevant and statistically significant reductions in both IOP and medications.”
Proof of concept for dropless immunosuppression after PK
A Phase 2, non-randomized safety/pilot study published in the British Journal of Ophthalmology evaluated the safety/efficacy of a subconjunctival dexamethasone implant after penetrating keratoplasty (PK). According to the paper, 14 patients with low rejection risk received the implant, followed by a steroid drop regimen after the implant was absorbed. There was no increase in IOP or other adverse events related to the implant. One patient, who had corneal neovascularization preop, experienced graft rejection. The authors supported the possibility of the dropless method for immunosuppression.
Topline Phase 2 data for high-dose aflibercept in wet AMD
Regeneron announced topline results from its ongoing Phase 2 proof of concept trial using 8 mg of aflibercept for wet AMD. According to the company’s press release, this dosage was compared to the currently approved 2-mg dose of aflibercept (EYLEA, Regeneron). No new safety signals were raised, the company reported, and of patients in the group who received the 8-mg injection, 43.4% had no retinal fluid compared to 26.4% in the 2-mg group at week 16. Both groups had received three doses at this timepoint. The trial will continue through week 44 with dosing extended to every 12 weeks or more frequently, if required. According to the company’s press release, there are also two ongoing Phase 3 trials evaluating 8-mg aflibercept compared to 2-mg EYLEA in wet AMD and DME, assessing safety and efficacy (visual acuity is the primary endpoint) for up to 2 years.
Companies enter licensing agreement for investigational ophthalmic therapies
A press release from Visus Therapeutics announced a licensing agreement with Cella Therapeutics to develop therapies to treat glaucoma and AMD. The press release also announced a licensing agreement with DelSiTech to develop drug delivery technology for ophthalmic therapies.
ASCRS news and events
- ASCRS Clinical Survey: There are only a few days left to take the ASCRS Clinical Survey, which closes at the end of August. ASCRS members, please take 15 minutes of your time to contribute valuable data to this initiative.
- ASCRS Glaucoma Building Blocks: Registration for this four-episode, on-demand CME series in comprehensive glaucoma management is reopened for a limited period of time. Learn more and register for this program to strengthen your foundation in modern glaucoma management.
Research highlights
- Meta-analysis that included 31 studies, covering more than 1.2 million anti-VEGF injections, evaluated safety outcomes when these injections were performed in the office vs. in the operating room. The rates of endophthalmitis and culture-positive endophthalmitis were evaluated. According to the paper, comparative analysis found no difference in the rates of endophthalmitis after the anti-VEGF injections (there was, however, a higher rate of culture-positive endophthalmitis in the office setting). Overall endophthalmitis rates associated with anti-VEGF injections were 0.03% and 0.02% in office and hospital, respectively. Pooled rates for culture-positive endophthalmitis were the same in both settings. Ultimately, the authors of the paper published in JAMA Ophthalmology concluded that they “could not determine if it is more appropriate to give treatment in the OR for safety reasons in low-income compared with higher-income regions in the world.”
- A brief published in the journal Eye described a case of acute corneal allograft rejection shortly after COVID-19 vaccination. According to the authors, unexpected ocular symptoms began 3 days after the patient received the Pfizer-BioNtech COVID-19 vaccine. The patient had bilateral DSAEK for Fuchs (with a PKP after failed DSAEK in the left eye) about 4 months before receiving the mRNA vaccine. Two months after the PKP, the patient’s eye was 6/18 with a clear corneal graft. When the patient presented with ocular symptoms after the COVID-19 vaccine, she was count fingers only in the eye that had PKP and she was diagnosed with acute corneal endothelial graft rejection. The patient’s right eye was unaffected. Graft rejection was resolved by week 3 after a regimen of hourly topical dexamethasone 0.1% in the affected eye and a week of oral acyclovir 400 mg 5x/day. The authors described this case as the second report of corneal allograft rejection following COVID-19 vaccine.
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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