Phase 3 trial investigating inflammation, pain management after cataract surgery

Oculis announced the first patient has been enrolled in its Phase 3 trial investigating OCS-01 (dexamethasone) for treatment of inflammation and pain following cataract surgery. The Phase 3 OPTIMIZE trial is randomized, double-blind, placebo-controlled, and taking place at 25 U.S. sites with the goal of enrolling about 240 patients. Efficacy measures include absence of anterior chamber cells at day 15 postop and absence of pain at day 4 postop, according to the press release. The same drug is also under investigation for DME and treatment of inflammation and pain following ocular surgery in general, the company reported.

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Positive topline data in study for RP gene therapy

MeiraGTx announced positive topline data from its Phase 1/2 study evaluating botaretigene sparoparvovec (AAV-RPGR), an investigational gene therapy treatment for patients with X-linked retinitis pigmentosa. According to the company’s press release, the therapy was “generally safe and well-tolerated” and demonstrated significant improvements in retinal function, visual function, and functional vision compared to the randomized control group. These results, the company continued, were observed in the dose escalation and expansion phases of the MGT009 study. The Phase 3 Lumeos study of the same therapy for treatment of patients with X-linked RP with variants in the RPGRgene is currently dosing patients.

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Study: Intravitreal cancer drug found to preserve vision more than traditional therapy

Aura Biosciences shared retrospective analysis that found its intravitreal belzupacap sarotalocan for treatment of early stage choroidal melanoma preserved visual acuity more than the traditional plaque radiotherapy. According to the company’s press release, the retrospective, matched, case-control study assessed visual acuity outcomes of 43 patients from the Phase 1b/2 trial evaluating belzupacap sarotalocan in patients with early stage choroidal melanoma compared to 150 patients with small choroidal melanoma treated with plaque radiotherapy. Both groups were at high risk for vision loss with the tumor edge within 3 mm of the fovea. The press release reported that the study found patients treated with radiotherapy had long-term, progressive, and irreversible vision loss when the tumors were close to the fovea. Vision loss in those receiving radiotherapy was 3 lines or more in most patients as early as 2 years and 6 lines or more as early as 3 years. Representatives of the company stated that this research highlights the high unmet need for early, vision-preserving therapy.

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Several studies show efficacy of home-based OCT

Notal Vision pulled together several studies that show the efficacy of the Notal Home OCT. One of these studies, a prospective, cross-sectional study that included 333 patients with wet AMD (600 eyes) showed that 91% of patients were able to successfully acquire the images with imaging on the home device showing more than 95% agreement with in-office imaging for detection of fluid. A separate prospective, longitudinal study that included 15 patients with wet AMD and no prior training with the device before it was sent to their home showed that patients had a 95% success rate in taking scans (2,300 total scans were taken). This latter study also found an average of 5.8 scans were taken each week by patients, which the company equated to strong compliance. Finally, the company included a 26-patient study that compared the Notal Home OCT scans with expert-graded commercial OCT scans, finding a more than 97% correlation between the two.

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Company announces expense reduction and refocus plan

Oyster Point Pharma announced a plan to reduce its expenses and refocus on the launch of TYRVAYA (varenicline solution), delivered as a nasal spray, currently indicated for dry eye. According to the company’s press release, it plans to reduce operating expenses by $6–8 million in the second half of 2022 and by $40–48 million in 2023. The effort, the company continued, will lower operating expenses in 2023 compared to those in 2022. The company also announced that it would refocus research and development efforts of its OC-01 varenicline solution to target various stages of neurotrophic keratopathy (results from a Phase 2 clinical trial investigating its impact on stage 1 neurotrophic keratopathy is expected in the fourth quarter of this year).

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ASCRS news and events

• ASCRS Summer Meeting: Register for the ASCRS Summer Meeting to get a “Taste of ASCRS”—its focused, anterior segment CME and its experience—August 19–21, in Nashville, Tennessee.
• Beyond 20/20: The full 4-episode, CME program for Beyond 20/20: An ASCRS Series in Modern Refractive Surgery and Presbyopia Therapy is now available on demand.
• ASCRS Satellite CME: Six complimentary CME resources are available online here.
• ASCRS advocacy win: After a year of advocacy from ASCRS, AAO, and the grassroots actions of our members, Aetna has dropped its prior authorization requirement for cataract surgery in most states. Read more here.

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Research highlights

• Recent research published in the journal Ophthalmology adds to a growing body of literature that supports time outdoors as a method to help stem myopia onset and/or progression. The prospective, cluster-randomized, examiner masked study included 6,296 children ages 6–9 from 24 schools in Shanghai, China. Students were randomized to receive 40 minutes or 80 minutes of outdoor time during the school day or to be in the control group, which continued its usual outdoor time. According to the paper, outdoor and indoor time and light intensity was measured with a wearable on the wrist during a second year of follow-up. The authors reported an unadjusted 2-year cumulative incidence of myopia of 24.9%, 20.6%, and 23.8% for the control, 40-minute outdoor group, and 80-minute outdoor group, respectively. After adjusting, incidence decreased by 16% in the 40-minute group and 11% in the 80-minute group, compared to control. There was less myopic shift and axial elongation in the test groups compared to control, but there was no significant difference in adjusted incidence of myopia and myopic shift between the test groups, the authors reported. The authors concluded that “increasing outdoor time reduced the risk of myopia onset and myopic shifts, especially in non-myopic children.” They also noted that exposure and light intensity were related to the protective effect of outdoor time.
• A novel IOL power calculation formula—the O formula—was recently described in the Journal of Cataract & Refractive Surgery online. The authors described the formula as based on ray tracing without commonly used parameters, including ultrasound compatible axial length, keratometry readings, and A-constant. The retrospective consecutive case series included 423 eyes that received a single-piece, L-loop, acrylic IOL with biometric data for the O formula obtained with SS-OCT tomography and biometry. Performance of the O formula was compared to the Barrett Universal II and the Kane formulas. The investigators found the standard deviation of prediction errors was lower with the O formula compared to Barrett, but it was not significantly different compared to the Kane formula. The paper reported that 75.4% and 98.6% of patients were within ±0.50 and ±1.00 D of target with the O formula, 77.1% and 97.9% with the Barrett formula, and 76.7% and 98.1% with the Kane formula. The authors concluded that the O formula is “one of the promising approaches for IOL power calculation,” but they noted that larger-scale studies are needed. “It may be used as an alternative in IOL power calculation because of its independence from commonly used parameters,” the investigators wrote.

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Product news

• Harrow Health has launched IOPIDINE 1% and MAXITROL 3.5 mg/10,000 units/0.1% commercially in the U.S. It plans to commercialize MOXEZA 0.5%, which was also among the FDA-approved ophthalmic medicines it recently acquired, at a later date.

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