Results from Phase 2a study evaluating glaucoma drop

VivaVision Biotech announced Phase 2a results for its glaucoma drop, VVN539, which was evaluated in patients with primary open angle glaucoma or ocular hypertension. According to the company’s press release, the main goal was to evaluate ocular hypotensive efficacy of two concentrations (0.04% and 0.02%) followed by ocular and systemic safety. Participants showed a clinically and statistically significant decrease in IOP with 0.04% being significantly superior compared to vehicle at all nine timepoints in the 21-day study. Compared to unmedicated baseline, the IOP decrease was 5–6 mm Hg. The company reported that 0.02% showed statistically significant decreases compared to unmedicated baseline at the “majority of time points.” The investigators reported a 1–2 mm Hg reduction in IOP in the vehicle alone group. According to the company, with the drug being well tolerated and showing significant clinical activity, further studies will continue with a larger patient population. The company described VVN539 as a first-in-class, duo MOA small molecule that acts on the trabecular meshwork to increase outflow.

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Enrollment complete for epi-on crosslinking trial

Glaukos has completed enrollment for its Phase 3 confirmatory trial for Epioxa epi-on crosslinking. The company announced that it expects the results of this trial, along with its already completed, initial Phase 3 trial for Epioxa epi-on crosslinking, will support its NDA submission by the end of 2024. According to the company’s press release, this Phase 3 confirmatory trial enrolled 312 eyes, which will be randomized 2:1 to receive Epioxa or placebo/sham procedure. The primary efficacy endpoint is mean change in Kmax from baseline to month 12. The company stated that it and the FDA would consider a statistically significant difference in this endpoint between treatment and control groups and a difference of 1 or more diopters a success.

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Phase 2 clinical trial begins for investigational dry eye drop

OKYO Pharma announced that it began dosing patients in its randomized Phase 2, multicenter, double-masked, placebo-controlled trial evaluating OK-101 for treatment of dry eye disease. This comes after a 2-week run-in period with placebo, intended to minimize a placebo effect. OK-101, according to the company’s press release, is a “lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor … typically found on immune cells of the eye responsible for inflammatory response.” In mouse models, the therapeutic agent has shown anti-inflammatory and pain-reduction activity. The company reported that the Phase 2 study includes three cohorts of 80 patients (placebo, OK-101 0.05%, and OK-101 0.1%). Each cohort receives the drops twice daily for 14 weeks (12 weeks of treatment after run-in period). Topline data is expected in the fourth quarter of 2023.

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Enrollment complete for Phase 2 study to evaluate diabetic retinopathy treatment

EyePoint Pharmaceuticals announced completion of enrollment for its Phase 2 clinical trial evaluating EYP-1901 for treatment of moderate to severe non-proliferative diabetic retinopathy (NPDR). According to the company’s press release, this study enrolled 77 patients who are going to be randomly assigned to receive EYP-1901 (2 mg or 3 mg as a single injection) or control (sham injection). The primary endpoint is improvement of at least two diabetic retinopathy severity scale levels at week 36 after injection, the company reported. The press release said that EYP-1901 is delivered in an erodible formulation using Durasert delivery with vorolanib, a tyrosine kinase inhibitor licensed to EyePoint by Equinox Sciences. Topline data is expected in the second quarter of 2024.

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Phase 2b trial for wet AMD treatment begins enrollment

Clearside Biomedical has begun enrollment for its Phase 2b clinical trial of CLS-AX (axitinib injectable suspension via suprachoroidal delivery) for treatment of wet AMD. According to the press release, the company seeks to enroll “treatment-experienced” patients with wet AMD who will be randomized 2:1 to receive either CLS-AX or aflibercept. Topline results from this trial are expected in the third quarter of 2024.

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ASCRS news and events

• ASCRS Summer Meeting: The ASCRS Summer Meeting in Nashville, Tennessee, returns August 11–13. Early bird registration pricing is ongoing through June 26.
• Cataract Awareness Month: June is Cataract Awareness Month. Follow ASCRS on social media to keep up with the latest on this important awareness effort.

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Research highlights

• Three-year safety and efficacy results of NVK002 (Vyluma), a preservative-free, low-dose (0.01% and 0.02%) atropine, were published in JAMA Ophthalmology. This Phase 3 clinical trial was double-masked, placebo-controlled, parallel-group, and randomized 2:2:3 (for once daily control, 0.01%, 0.02%) at 26 sites in North America and five in Europe. Patients were between 3–16 years old with –0.5 to –6.0 D spherical equivalent refractive error and astigmatism of –1.5 D or less. A total of 573 participants were randomized and received treatment. At month 36, according to the paper, 0.01% atropine, compared to placebo, significantly increased the responder proportion, slowed mean spherical equivalent refractive error (SER), and slowed axial length elongation. Atropine 0.02%, the authors reported, also showed a benefit, but it did not significantly increase the responder proportion or slow SER progression. There were no serious ocular adverse events. The authors reported that these results suggest efficacy of atropine 0.01% at all endpoints compared to placebo, suggesting that it could be a treatment option for pediatric myopia progression.
• A retrospective case series published in the Journal of Cataract & Refractive Surgery sought to evaluate LASIK for correction of moderate to high hyperopia (≥3.50 D and ≤6.50 D). According to the paper, 6-month data from 92 eyes that underwent hyperopic LASIK with the VisuMax 500 femtosecond laser (Carl Zeiss Meditec) and Amaris 750 excimer laser (Schwind eye-tech-solutions) had a mean treated sphere of 4.69±0.87. According to the authors, the efficacy index was 0.91 and 0.90 at 6 months and 36 months, respectively; safety index was 1.0. UDVA was 20/20 or better in 72% of patients with spherical equivalent within 0.5 D in 80% of patients and within 1 D in 93% of patients. Seventeen percent of patients gained one or more lines of CDVA. Thirteen percent of patients experienced a loss of 1 line of corrected distance visual acuity (no patients lost 2 or more lines). The authors reported “slight but significant” regression at 36 months and noted that 21.73% required flap lift for enhancement and 11.95% orthoptic visual rehabilitation for accommodative disorders. The authors concluded that this safety and efficacy is similar to that of previously reported refractive lens exchange for hyperopic patients, and thus they “defend the maintenance of LASIK as first line therapy.”

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Product news

• New Apple products (iOS 17, iPadOS 17, and watchOS 10) will have vision health features, which the company described as those that “encourage healthy behaviors that help reduce the risk of myopia.”

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