FDA issues eight warning letters

Amid ongoing concern of certain eye drops being associated with sterility issues (several brands over the last year have been recalled), the FDA has issued warning letters to eight companies for manufacturing or marketing of unapproved ophthalmic drug products. The FDA stated that these warning letters were issued to companies with drops that were “illegally marketed to treat conditions such as conjunctivitis (‘pink eye’), cataracts, glaucoma, and others.” Companies that received letters were: Boiron, CVS Health, Dr Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan AG/Similasan USA, TRP Company, and Walgreens Boots Alliance.

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Positive Phase 2 safety update for investigational treatment of retinal diseases

EyePoint Pharmaceuticals provided a safety update for its ongoing Phase 2 trials evaluating EYP-1901 as a 9-month treatment for moderately severe to severe non-proliferative diabetic retinopathy and a 6-month maintenance treatment for wet AMD. According to the company’s press release, about 170 patients have received EYP-1901 and have at least 3 months of post-injection follow-up in these two trials. No drug-related ocular severe adverse events or systemic severe adverse events have been reported. EyePoint expects to report topline data for the trial evaluating the treatment’s effect on diabetic retinopathy in the second quarter of 2024 and data for the trial evaluating EYP-1901 for wet AMD in December 2023. According to the press release, EYP-1901 is a sustained-delivery treatment based on the company’s Durasert delivery technology with vorolanib, a tyrosine kinase inhibitor.

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First-in-human titratable glaucoma therapy system

Myra Vision announced that it has begun a first-in-human clinical study of its Calibreye System, which it described as a glaucoma drainage device with titratable outflow control. This device is targeted for moderate to severe glaucoma patients. The current study is a prospective, non-randomized, open-label feasibility study, aiming to evaluate the clinical procedure, safety, and performance of the system for patients with open angle glaucoma.

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Companies partner to develop biological dry eye treatment

Link Biologics and Thea entered into an agreement to develop Link_TSG6 as a treatment for dry eye disease and other ophthalmic indications. According to the press release, Link_TSG6 is a biological drug based on TSG-6, which is a protein that protects tissues from inflammatory damage. The companies reported that it has already been tested in preclinical models, including models of dry eye disease. The press release reported that Link Biologics will be responsible for reach and development through the end of Phase 2 trials, then Thea will take over further development and commercialization.

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Geographic atrophy drug development discontinued

Novartis announced that it was discontinuing development of GT005 for treatment of geographic atrophy secondary to dry AMD.

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ASCRS news and events

• ASCRS Annual Meeting: The call for submissions for the 2024 ASCRS Annual Meeting is going on now through October 9. Find submission details here.
• ASCRS Live Webinar: “A Challenging Day in the OR: Tough Choices in IOL Selection,” a live educational event, will take place Tuesday, September 26 at 9:00 p.m. ET. Register now for this webinar that will cover four unique cases.

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Research highlights

• Calcium channel blockers (CCBs), commonly used to lower blood pressure, have been associated with an increased risk of glaucoma. A study published in JAMA Ophthalmology took a look at the systemic use of CCBs with glaucoma and other related traits, using participants in the UK Biobank (2006–2010). The UK Biobank data in the study included 427,480 adults, 33,175 of whom used CCBs (7.8%). The authors found that people who used CCBs had 39% higher odds of developing glaucoma. Use of these drugs was also associated with a thinner macular ganglion cell-inner plexiform layer and macular retinal nerve fiber layer. There was not an association between CCB use and IOP, which according to the authors “suggests that an IOP-independent mechanism of glaucomatous neurodegeneration may be involved.” The authors maintained that a causal relationship between CCBs and glaucoma development has not been established but that “CCB replacement or withdrawal may be considered should glaucoma progress despite optimal care.”
• The relationship between preoperative corneal stiffness and residual refractive error after SMILE was evaluated in a retrospective cohort study published in the Journal of Cataract & Refractive Surgery. The study included 287 eyes and found that there was more under correction in eyes that had “less-stiff corneas” regardless of timepoint. The authors wrote that postop refraction had a mean 0.05 D under correction for every 0.1-unit decrease in stress-strain index. This stress-strain index, the authors continued, “accounted for nearly 10% of the variance in refractive outcomes.” Overall, the authors reported that those with less-stiff corneas had a “2- to 3-fold increased risk of residual refractive error after SMILE.” They suggested that this knowledge could help modify nomograms and improve postop predictability.

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Product news

• MIEBO (perfluorohexyloctane ophthalmic solution, Bausch + Lomb) began its commercial launch in the U.S. as the first FDA-approved eye drop for dry eye disease directly targeting tear evaporation.

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