EW Weekly, June 19, 2020

First patient dosed in optogenetic Phase 1/2 trial for retinitis pigmentosa
Bionic Sight announced the first patient is being dosed in its Phase 1/2 clinical trial for an optogenetic gene therapy, BS01, for retinitis pigmentosa. According to the company, optogenetic proteins in BS01 receive light coming into the eye and convert it into signals that are sent to the brain by a device that helps the patient’s optic nerve. Bionic Sight stated that this open-label, dose-escalation study is for patients with advanced retinitis pigmentosa. After the first patient was dosed, additional enrollment was put on hold due to the COVID-19 pandemic, but Bionic Sight hopes to resume enrollment in the second half of 2020.

Zimura sees positive Phase 3 results
Iveric bio announced positive 18-month results from its Phase 3 clinical trial for Zimura (avacincaptad pegol) for treating geographic atrophy secondary to AMD. Zimura, according to the company’s press release, is a novel complement C5 inhibitor that in the 18-month study reduced the mean growth rate of geographic atrophy by 28.11% in the 2 mg group compared to the control group and by 29.97% in the 4 mg group compared to control. The company reported no adverse events related to Zimura.

Positive results for Phase 2a treatment for Demodex blepharitis
There is currently no FDA-approved prescription for Demodex blepharitis, but Tarsus Pharmaceuticals announced positive results from its Phase 2a Mars study. The study for TP-03, which targets the mite’s nervous system, was single arm and open label and showed a drop in mite density by day 14 with no adverse events reported. According to the company press release, results from a randomized control study for TP-03 will be released soon. There was a 10-fold improvement in average mite density per lash by the end of the 28-day treatment period with treatment effects lasting out to 90 days, according to Tarsus.

ASCRS changes date of 2021 Annual Meeting
ASCRS announced a date change for its 2021 Annual Meeting, moving it from April to August 13–17, 2021, in San Francisco, California. This decision was made in light of the current and projected challenges with SARS-CoV-2 and the hope for development, approval, and administration/availability of a vaccine. ASCRS communications stated that dates for abstract submission, exhibit contracts, and registration will be kept as close to historical dates as possible. ASCRS will return its Annual Meeting to the spring in April 2022 in Washington, D.C.

ASCRS and IJCAHPO Technicians & Nurses Program virtual broadcast
Technicians and nurses are encouraged to join the final installment in a virtual broadcast series of topics from the 2020 Technicians & Nurses Program sponsored by IJCAHPO and ASCRS. The full program had the latest information on cataract and refractive surgical topics with the potential to earn up to 21 IJCAHPO credits over 3 days. Part 3, the final part of the series, purchased separately from Part 1 and Part 2, will take place on June 27 from 8:00 a.m.–5:00 p.m. CDT for the potential of up to 7 IJCAHPO credits.

Research highlights
  • A cross-sectional study from a hospital database in the U.S. found that nearly 2,000 ocular injuries annually are related to fireworks. The database looked at injuries occurring between 1999–2017, finding ocular burns to be the most common type of firework-related injury. The research also identified firecrackers and bottle rockets as the most common types of firework materials that cause injuries, with bottle rockets being associated with the most severe injuries. In the 19-year study period, there were more than 34,500 firework-related injuries, 65.9% of which were in patients 18 years or younger; 71.9% of cases were male. While sustained ocular burn was the most common injury (62.9%), ruptured globe (2.8%), foreign bodies (11.7%), conjunctival irritation (9.6%), and other severe ocular trauma (4.6%) also occurred. These findings and more were published in JAMA Ophthalmology.
  • Evidence from the previous SARS and MERS outbreaks along with preliminary clinical experiences and other small studies of SARS-CoV-2 suggests that immunosuppressive drugs for ophthalmology patients are safe to continue amid the COVID-19 pandemic. The research published in the British Journal of Ophthalmology by Thng et al. states that it appears safe to continue immunosuppressive drugs, except for high-dose corticosteroids or perhaps for patients who are at higher risk for COVID-19 disease.
  • Research has led to a mouse model for the zonular instability seen in Marfan patients. The research published in Disease Models & Mechanisms describes how a disruption induced in fibrillin-1 led to significantly decreased zonular strength and eventual development of ectopia lentis as the mouse aged. Other Marfan-like ocular symptoms were observed in the mice as well. The investigators disrupted fibrillin-1 gene expression at the end of the zonules where they attach to the lens or where they attach to non-pigmented ciliary epithelium. According to the research, the disruption at the lens end did not have an effect, while the disruption at the non-pigmented ciliary epithelium did. This technique, according to the researchers, could provide a mouse model for testing therapies.
  • Doctors described a novel aerosol prevention box to be used to reduce the risk of COVID-19 transmission during administration of regional anesthesia. The doctors wrote that while regional anesthesia has been recommended during the pandemic because it doesn’t require intubation or extubation, they described how regional anesthesia can result in sneezing that could thus transmit the virus. They showcased a novel aerosol prevention box to be placed around the patient’s head to protect against such transmission during anesthesia administration for ocular surgeries. The concept is described in the journal Eye.

Product news
  • ADX-2191 (Aldeyra Therapeutics), already an investigational therapy for proliferative vitreoretinopathy in the U.S., received orphan medicinal product designation by the European Commission.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

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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