FDA approves first pharmacologic treatment of ROP for preterm infants

Regeneron announced FDA approval of EYLEA (aflibercept injection) as the first pharmacologic treatment for preterm infants with retinopathy of prematurity (ROP). According to the company’s press release, this is the first pediatric approval for EYLEA, which is now indicated for five retinal conditions. Data from two Phase 3 trials supported this approval, finding that 0.4 mg of EYLEA (vs. laser photocoagulation) in infants with ROP resulted in an absence of active ROP in about 80% of patients.

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FDA accepts NDA for dilation reversal drop

Ocuphire reported that the FDA accepted its NDA for Nyxol (phentolamine ophthalmic solution) for the treatment of pharmacologically induced mydriasis. The PDUFA date is set for September 28. If approved, Nyxol would become the only commercially available drop for reversal of dilation, according to the company. The NDA submission is based on positive findings in a Phase 2b trial, two Phase 3 pivotal trials, and a Phase 3 pediatric trial, all of which totaled to more than 600 participants.

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Phase 2b results for anti-VEGF agent for wet AMD

Opthea announced publication of its Phase 2b results for OPT-302, an anti-VEGF-C/-D “trap” agent, in combination with ranibizumab for treatment of wet AMD. The prospective, randomized, controlled, multicenter study that enrolled 366 treatment-naïve patients is published in the journal Ophthalmology. According to the company’s press release, patients received monthly administration of 2 mg of OPT-302 with standard-of-care ranibizumab. The primary efficacy endpoint of a statistically superior gain in visual acuity compared to ranibizumab alone at 24 weeks was achieved. More patients in the OPT-302 combination therapy group gained 10 or more letters and showed reduced swelling and vascular leakage, the company reported. These findings support that the combination therapy delivers superior visual results compared to anti-VEGF monotherapy. According to the company, Opthea is conducting two confirmatory Phase 3 studies with OPT-302 and ranibizumab and OPT-302 and aflibercept, with the endpoint in both studies being superiority in visual acuity gains at 12 months.

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Interim results for Phase 1 study evaluating hydrogel implant for retinal diseases

Ocular Therapeutix announced 10-month, interim results from its Phase 1 study of OTX-TKI, an axitinib intravitreal hydrogel implant for treatment of retinal diseases, such as wet AMD and diabetic retinopathy. The results support the potential for OTX-TKI to enhance durability of treatment of wet AMD, with the implant controlling wet AMD for up to 10 months after a single administration, according to the company’s press release. This ongoing study enrolled 21 patients at 6 clinical sites who were randomized to receive OTX-TKI with a 2 mg aflibercept injection 4 weeks post-implant or aflibercept injections every 8 weeks (control). According to the company, the trial is designed to assess safety, durability, tolerability, and biological activity (as measured by BCVA and central subfield thickness [CSFT] of the retina). More specific results showed comparable stable, sustained BCVA and CSFT between the study group and the control arm. According to the company, there was a 92% reduction in treatment burden in the OTX-TKI group.

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Data from ongoing Phase 1/2 clinical trial of gene therapy for Leber congenital amaurosis

Atsena Therapeutics announced data from its ongoing Phase 1/2 clinical trial of ATSN-1010 as a gene therapy treatment for Leber congenital amaurosis caused by bilateral mutations in the GUCY2D (LCA1) gene. This data supported the positive safety and efficacy of the gene therapy, with subretinal delivery being well tolerated and resulting in “clinically meaningful improvements in vision in patients treated with the highest dose,” according to the company’s press release.

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting, May 5–8, 2023, in San Diego, California, is ongoing. “Make Waves” in education, innovation, and networking specifically focused on anterior segment surgery.
• ASCRS Annual Meeting Preview Program: The ASCRS Annual Meeting Preview Program is available online with more details about Annual Meeting schedules and programming.
• Eyecelerator: Registration is now open for Eyecelerator @ ASCRS 2023. The innovation conference from ASCRS and the American Academy of Ophthalmology will be held on May 4 in San Diego, California. Join investors, industry leaders, and ophthalmologists at this showcase of companies, technology, and other exciting innovation topics in ophthalmology. Sponsorship opportunities and opportunities to present at the Eyecelerator Marketplace are available now. More detailed program information will be coming soon.
• ASCRS Podcast: The latest episode of Ophthalmology Quicksand Chronicles, featuring guest David Chang, MD, is online now.

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Research highlights

• An observational, descriptive clinical study out of a single center evaluated the effect of cataract surgery on patients’ blinking. Patients (n=50) were evaluated preoperatively and at 1 month and 3 months postop. Blinking at each visit was recorded for 90 seconds with an eye-tracking device. Blink rate, completeness, and other kinematic parameters were later assessed with image analysis. After 3 months postop, the authors reported that the blink rate was significantly lower than baseline and 1 month postop. The number of complete blinks was also significantly smaller (percentage of incomplete blinks significantly higher) at 3 months postop compared to baseline (no statistical difference was seen at the 1-month postop visit). The authors reported no difference in the number of incomplete blinks or kinematic parameters between visits. The investigators concluded that clinicians should be aware that cataract surgery alters blinking patterns postop, which could have an effect on the ocular surface. The research is published in the Journal of Cataract & Refractive Surgery.
• A retrospective, cross-sectional review based on electronic health record (EHR) data sought to better understand blindness risk upon first presentation for glaucoma. The study, published in the American Journal of Ophthalmology, used EHRs from the Duke Ophthalmic Registry, looking at glaucoma (but excluding concurrent diseases), blindness classification, and risk factors such as gender, race, marital status, age, IOP, diabetes, income, and education. The dataset included 3,753 patients, 192 of whom (5%) were blind upon first presentation to the glaucoma clinic. African American/Black race, single marital status, prior diabetes diagnosis, and higher IOP were associated with an increased risk for presenting blind due to glaucoma. Higher annual income and education were associated with a lower risk of presenting blind due to glaucoma. The authors wrote that these results “highlight disparities in healthcare outcomes and indicate the importance of targeted education to reduce disparities in blindness.”

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Product news

• Bruder Healthcare expanded its portfolio of dry eye products by entering into an exclusive licensing agreement with Dry Eye Drink, which produces an anti-inflammatory, antioxidant, and anti-bacterial hydrating drink mix for patients with dry eye disease.
• CIMERLI (ranibizumab-eqrn, Coherus BioSciences), an FDA-approved biosimilar to Lucentis (ranibizumab, Genentech), received a Q-Code from CMS, effective after April 1.
• Visionix launched its Optovue Solix FullRange OCT device in North America. The technology includes FullRange anterior scans, posterior high-density scan patterns, fundus cameras, external photography, and external IR imaging.

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