Phase 3 results reported for novel glaucoma eye drop

Nicox announced publication of its Phase 3 results for NCX 470, a nitric oxide-donating bimatoprost eye drop for treatment of open angle glaucoma or ocular hypertension. According to the company’s press release, results from this randomized, controlled study that compared NCX 470 to latanoprost were published in the American Journal of Ophthalmology. The authors concluded that NCX 470 was well tolerated and lowered IOP more than latanoprost at all 6 time points among study participants. The study described NCX 470 as having a dual mechanism of action that “enhances uveoscleral and trabecular outflow.” A separate Phase 3 trial being conducted in the U.S. and China is expected to have topline results by the second quarter of 2025.

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Update: preventative therapy for patients at risk for radiation retinopathy

Alimera Sciences announced that the first patient was randomized in its study evaluating intravitreal faricimab (6.0 mg) injections or ILUVIEN (fluocinolone acetonide, 0.19 mg) implant vs. observation alone for patients who are at risk for radiation retinopathy. According to the company’s press release, the study will enroll 600 patients with choroidal melanoma who are being treated with plaque brachytherapy, which puts them at risk for macular edema and visual acuity loss. The company’s leadership, in the press release, stated that they think “continuous microdosing” with ILUVIEN could “prevent, delay, or reduce” radiation retinopathy.

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Topical drop for diabetic retinopathy does not meet endpoints in Phase 2 trial

OcuTerra Therapeutics announced that nesvategrast did not meet its primary or key secondary endpoints in its Phase 2 trial, though it was found safe and well tolerated. Nesvategrast was being developed as a possible topical therapy for diabetic retinopathy. According to the company’s press release, it did not result in a statistically significant improvement on the diabetic retinopathy severity scale compared to placebo and did not have a significant impact on progression. The press release did report that there was a significant improvement in preventing development of vision-threatening events in patients with diabetic retinopathy severity scale levels 47 and 53. The company plans to evaluate and share its strategic alternatives at a later date.

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ASCRS news and events

• ASCRS Annual Meeting: The ASCRS Annual Meeting is just a few weeks away, April 5–8 in Boston, Massachusetts. There is still time to register online or onsite. Take a look at the 2024 Annual Meeting & Subspecialty Day Real-Time Program for more details.
• EyeWorld Corporate Events: EyeWorld is hosting more than a dozen Corporate Education events during the ASCRS Annual Meeting in Boston. Click here to learn more about these opportunities and to pre-register.

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Research highlights

• A prospective nonrandomized observational study published in the Journal of Cataract & Refractive Surgery sought to identify risk factors for haptic malposition in eyes with ICLs. The study included 134 patients who had ICLs and completed 1 year of follow-up. Extent of haptics in the ciliary sulcus (ICS) was measured, and patients were categorized based on this measurement from 0 to 4. According to the paper, the position of the haptics was quantified as the distance between the iris root and terminal haptic tip. The authors found that [the measurement of haptics in the ciliary sulcus] “was 0 ICS in 19 eyes (14.2%), 1 in 22 eyes (16.4%), 2 in 32 eyes (23.9%), 3 in 29 eyes (21.6%), and 4 in 32 eyes (23.9%).” Multiple linear regression analysis showed that iris-ciliary angle, maximum ciliary body thickness, distance between the sulcus-to-sulcus plane and the anterior surface of the crystalline lens, and ICL size were significantly associated with iris root to haptic tip distance. The authors also reported that spherical equivalents, sulcus-to-sulcus plane and the anterior surface of the crystalline lens, and the extent of haptics in the ciliary sulcus were correlated with central vault. The authors concluded that a shortened ciliary process is the most common risk factor for haptic malposition and that the extent of haptic in the ciliary sulcus is significantly related to central vault.
• The long-term efficacy of low-concentration atropine over 5 years was reported in a randomized, double-masked, extended trial study published in the journal Ophthalmology. The study also included the proportion of children needing retreatment and the efficacy of retreatment from year 3–5. Patients 4–12 years old from the original study were followed up for 5 years, and during the third year were randomized to continue treatment with 0.05%, 0.025%, or 0.01% atropine or to stop treatment. In years 4 and 5, those who were continuing treatment were switched to 0.05% atropine and those who stopped treatment were started on 0.05% atropine if they showed 0.5 D of progression or more after a year. According to the paper, 269 out of 326 children from the third year completed 5 years of follow-up. Mean spherical equivalent progressions were –1.34±1.40 D, –1.97±1.03 D, and –2.34±1.71 D for the continued treatment groups with 0.05%, 0.025%, and 0.01% atropine, respectively. Nearly 88% of patients who were randomized to stop treatment needed retreatment, and need for retreatment was similar across all concentrations. Those who had to restart treatment had similar efficacy results as those who continued treatment.

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