EyeWorld Weekly, September 16, 2022

EyeWorld Weekly, September 16, 2022

EyeWorld Weekly

September 16, 2022 • Volume 28, Number 36

‘Visionary Report’ sheds light on understanding, perspectives of AMD

Bausch + Lomb has issued its first annual Visionary Report, which gathered key insights on American understanding and perspectives about AMD. Among the many findings in the report was that 81% of Americans would be willing to give something up (vacationing, money, internet, etc.—even one of their other senses) for assurance of never losing their sight. While AMD is a leading cause of vision loss, 44% of Americans were concerned about developing it, and 61% weren’t aware that a dilated eye exam is needed to identify AMD. The company’s press release about the report also included that 75% of Americans had heard of AMD before but had not discussed it with an eyecare provider; 77% of them would be interested in such a discussion. According to the company, these perspectives were obtained from 2,073 respondents who received a poll April 14–18, 2022.

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NDA submitted for Demodex blepharitis treatment 

Tarsus Pharmaceuticals submitted an NDA to the FDA for TP-03 (lotilaner ophthalmic solution) for the treatment of Demodex blepharitis. According to the company’s press release, the submission includes data from the company’s two pivotal trials, which collectively included more than 800 patients and saw all endpoints met with the drug being well tolerated.

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Study complete for trial of oral diabetic retinopathy therapy

Ocuphire Pharma announced that the last patient has completed their final visit in a Phase 2b, 24-week trial of oral APX3330 for treatment of diabetic retinopathy. According to the company’s press release, topline results from the trial are expected in the fourth quarter of 2022. APX3330, if proven effective and approved, would be a first-in-class oral treatment for diabetic retinopathy and/or diabetic macular edema. The company reported that this study enrolled 103 subjects with moderately severe to severe non-proliferative diabetic retinopathy or mild proliferative diabetic retinopathy. Patients were randomized to receive 600 mg APX3330 or placebo, which they took daily over 24 weeks.

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Enrollment complete for study comparing dry eye therapeutic device to cyclosporine

Sight Sciences announced that enrollment is complete for its randomized, multicenter SAHARA study, which will compare use of a dry eye therapeutic device (the company’s TearCare System) to topical dry eye medication (Restasis, cyclosporine ophthalmic emulsion, Allergan). According to the company’s press release, the study, which enrolled 310 patients, will randomize patients 1:1 to receive either the 15-minute bilateral thermal TearCare treatment, which will then be followed by manual meibomian gland expression by a physician, or one drop of Restasis twice daily for 6 months. Clinical investigations will conclude at 6 months, according to the company. The primary superiority endpoint will be mean change from baseline in tear breakup time and OSDI scores. The company reported that after the 6-month readout, patients randomized to receive Restasis will have the TearCare treatment. From there all participants will be followed for 18 additional months to assess durability of TearCare and retreatment effect over a 2-year period. Results from the 6-month 1:1 study are expected in the second quarter of 2023.

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Gene therapy developed for ciliopathy associated with a form of Leber congenital amaurosis

The National Eye Institute (NEI), in a news article, described the development of a new gene therapy that rescues the cilia in retinal cells affected by a type of Leber congenital amaurosis (LCA) that is caused by mutations in the NPHP5 gene. This type, according to the article, leads to severe defects in the cilium. The NEI article explained that LCA can be caused by defects in at least 25 different genes. Some forms of LCA have treatment options available. The article continued that the type caused by NPHP5 mutations is relatively rare, causing bilateral blindness in all cases and in many cases leading to kidney failure. The NEI researchers used stem cell samples from patients with this gene deficiency to make retinal organoids that were then used to test therapeutic interventions. The researchers discovered that the organoids with this mutation had reduced levels of CEP290 protein, which the article explained usually interacts with NPHP5 and “forms the primary cilium gate.” Researchers introduced an AAV-vector with a functional NPHP5 gene, and the organoids showed restoration of opsin protein in its proper location (previously observed in unexpected locations). The authors suggested that this functional gene “may have stabilized the primary cilium gate.”

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ASCRS news and events

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Research highlights

  • A retrospective, single-site study reviewed cases of primary SMILE in order to determine enhancement rates and the results of PRK as an enhancement option when needed. The study, published in Clinical Ophthalmology, included 405 eyes that had SMILE. Of these, 15 needed an enhancement with PRK, for a rate of 3.7%. The study authors reported that there was no significant difference in the pre-SMILE data between the group that needed an enhancement and those that did not. After 1 year post-enhancement, all eyes in this group had UDVA of 20/40 or better, and 13 had a UDVA of 20/20 or better. All eyes were within 1 D of target, 13 were within 0.5 D, and 10 were within 0.25 D. The authors concluded that PRK was a safe and effective procedure for enhancement after SMILE. 
  • A prospective study published in the journal Cornea evaluated 94 eyes (47 patients) with chronic MGD and evaporative dry eye treated with light therapy in order to determine the effects of combined light therapy, intense pulsed light (IPL) and low-level light therapy (LLLT), on clinical and molecular outcomes. These therapies combined “demonstrated a marked improvement in clinical metrics,” the authors wrote. OSDI scores, 3 months after therapy, were significantly reduced in 95.6% of eyes, TBUT increased in 72.3% of eyes, and meibomian gland expressibility scores increased in 80.8% of eyes. The effects, the authors reported, were sustained out to 6 months follow-up. Inflammatory factors, such as MMP-9 and others, were reduced. The authors concluded that combined light therapy is promising in patients with chronic MGD and dry eye disease, with clinical and molecular changes supporting improvement in symptomatology and reduced inflammation.

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Product news

  • TearLab rebranded to Trukera Medical and launched the ScoutPro Osmolarity System, which combines specimen collection for osmolarity testing and laboratory analysis into a handheld device. 
  • LENSAR applied for certification in the European Union for its ALLY Adaptive Cataract Treatment System. ALLY received FDA clearance in June 2022 and subsequently began its commercial launch in the U.S.

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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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