- FDA approves image and data management/analysis platform
- Results from pivotal Phase 3 trial for new Demodex treatment
- Trial demonstrates safety, efficacy of mydriasis-reversal drug in pediatric patients
- Phase 3 pivotal trial for novel dry eye disease, MGD drug candidate
- Phase 3 results for investigational geographic atrophy therapy
- New coalition supports sustainability in ophthalmology
- ASCRS news and events
May 6, 2022 • Volume 28, Number 18
FDA approves image and data management/analysis platform
The FDA issued 510(k) clearance for RetinaAI Medical’s RetinAI Discovery platform, a system that is used to organize and analyze ophthalmic medical images. According to the company’s press release, this system can be used on OCT scans and fundus photos, for example, on the cloud to facilitate collaboration in real time. The company developed a set of AI models that quantify fluid and layer segments in retinal tissue to detect vision-threatening conditions, such as AMD, diabetic retinopathy, DME, and RVO. According to the company’s press release these models have the CE mark; RetinaAI Medical is planning on an FDA submission for them to be integrated into the Discovery system for automated analysis later this year.
Results from pivotal Phase 3 trial for new Demodex treatment
Tarsus Pharmaceuticals announced that it met primary and secondary endpoints for its investigational TP-03 (lotilaner ophthalmic solution) for treatment of Demodex blepharitis. This trial was randomized, controlled, double-masked, and enrolled 412 patients with more than 10 collarettes per lid, at least mild erythema, and at least 1.5 mites per lash. TP-03 was self-administered twice per day in each eye for 6 weeks, and during the study period (14 days prior or during the treatment) no other treatment for blepharitis was used. Fifty-six percent of patients receiving the drug achieved complete collarette cure, compared to 13% on vehicle; 89% of participants in the treatment group achieved clinically significant collarette cure at day 43 compared to 33% on vehicle. The company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2022.
Trial demonstrates safety, efficacy of mydriasis-reversal drug in pediatric patients
Ocuphire Pharma announced positive results from the pediatric safety study for its investigational mydriasis-reversal drug, Nyxol (phentolamine ophthalmic solution). The trial, MIRA-4, enrolled 23 pediatric patients ages 3–11 years, who received either Nyxol or vehicle 1 hour after receiving one of three mydriatic agents that are commonly used to dilate pupils for exams. According to the company’s press release, Nyxol was safe and well tolerated with no adverse events. Sixty-four percent of patients treated with Nyxol returned to baseline pupil diameter within 90 minutes after dosing, compared to 25% on placebo; 82% treated with Nyxol returned to baseline within 3 hours post-dose compared to 33% on placebo. The company stated that it plans to submit an NDA from the results of its four clinical trials to the FDA in late 2022.
Phase 3 pivotal trial for novel dry eye disease, MGD drug candidate
Bausch + Lomb and Novaliq announced data from its second Phase 3 clinical trial investigating NOV03 (perfluorohexyloctane) for treatment of dry eye disease associated with MGD. According to the company’s press release, both efficacy endpoints were met (total corneal fluorescein staining and VAS eye dryness at day 57), reinforcing the results for the first pivotal trial. The company stated that the clinical development program for NOV03 will conclude with an ongoing, multicenter, open-label, single-arm, 12-month safety extension trial.
Phase 3 results for investigational geographic atrophy therapy
Apellis Pharmaceuticals announced longer-term, 18-month data from its two Phase 3 studies of intravitreal pegcetacoplan, an investigational therapy for treatment of geographic atrophy (GA) secondary to AMD. The studies looked at monthly and every-other-month injections and found continuous, clinically meaningful reduction in growth of extrafoveal and foveal lesions. The treatment continued to demonstrate a favorable safety profile, the company’s press release reported. Apellis plans to use this data to submit an NDA to the FDA in the second quarter of 2022.
New coalition supports sustainability in ophthalmology
A global coalition of ophthalmologists and eye societies has formed EyeSustain to engage, network, and educate the ophthalmic community about sustainable practices. EyeSustain brings the most current information and resources about reducing surgical waste and ophthalmology’s environmental footprint into one location. With the highest procedural volumes in medicine, EyeSustain states on its website, “ophthalmology has a unique opportunity to lead efforts to make healthcare more economically and environmentally sustainable.” Learn more about EyeSustain on its website and in this EyeWorld article.
ASCRS news and events
- 2022 ASCRS Annual Meeting: Catch up on coverage from the Annual Meeting, which wrapped up on Tuesday, with the EyeWorld Daily and EyeWorld Onsite.
- ASCRS Grand Rounds: ASCRS Grand Rounds, 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 prospective, consecutive, survey-based case series from a single private practice evaluated patient perspectives of immediate sequential bilateral cataract surgery (ISBCS). Sixty-one patients were enrolled and 47 completed the surveys before and after their routine delayed sequential bilateral cataract surgery (DSBCS). Eighty-three percent had what the authors described as a favorable outlook of ISBCS preop; this dropped to 76.6% postop. Fifty-three percent said they were willing to accept additional risk in order to receive ISBCS. The authors of the study, which is published in Clinical Ophthalmology, concluded that “most patients had a favorable outlook of ISBCS before and after undergoing DSBCS. Patients with underlying systemic health co-morbidities were most likely to accept additional surgical risk, if necessary, to receive ISBCS.”
- According to a paper published in the journal Eye, there is “no diagnostic gold standard for keratoconus in children and adolescents.” The authors sought to investigate the diagnostic accuracy of various indices for keratoconus detection in this group. They used data from 432 normal pediatric eyes and 48 eyes with pediatric keratoconus and forme fruste keratoconus. These eyes were imaged with a rotating Scheimpflug camera. According to the paper, 36 indices were tested and most showed discriminative power in differentiating keratoconus and forme fruste keratoconus from normal corneas. The authors found that the most useful indices for keratoconus detection in the pediatric population were OCULUS values (CAIRO 8), Ambrosio’s relational thickness maximum and average, pachymetric progression index maximum and average, back elevation from the best-fit toric ellipsoid, the keratoconus index, topographic keratoconus indices, and the index of height decentration.
Product news
- Kala Pharmaceuticals announced that EYSUVIS (loteprednol etabonate ophthalmic suspension) is now covered by Pharmacy Benefit manager and Humana.
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: Sumit “Sam” Garg, 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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