FDA approves IND for neuropathic pain drug

OKYO Pharma announced FDA approval of its IND for OK-101, allowing the drug to begin clinical trials for treatment of neuropathic corneal pain. According to the company, OK-101 will be evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial, beginning in the second quarter of this year. The company plans to enroll about 54 patients. According to the press release, this was the first IND application for treatment of neuropathic corneal pain to be approved by the FDA.

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Phase 2 preliminary efficacy and safety data for wet AMD treatment trial

Adverum Biotechnologies announced positive preliminary efficacy and safety data from its Phase 2 trial evaluating ixoberogene soroparvovec (Ixo-vec) for patients with wet AMD. According to the company’s press release, both doses of Ixo-vec intravitreal gene therapy showed “maintenance of visual and anatomical outcomes,” including “a potentially best-in-class reduction in annualized [anti-VEGF] injections and the percentage of patients remaining free of annualized injections,” according to the company. At one of the doses, the treatment at 26 weeks showed an annualized reduction of anti-VEGF injection rates of 90% and the other dose a 94% reduction. Injection-free rates at 26 weeks among the doses were 68% and 85%. The company also reported that visual acuity and anatomic endpoints were maintained at both doses. From a safety standpoint, the treatment was well-tolerated with no serious adverse events.

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First-in-human data for DME, AMD therapy

EyeBio announced positive data from its first-in-human Phase 1b/2a clinical trial evaluating Restoret for treatment of diabetic macular edema (DME) and neovascular AMD. In the study, presented at the Macula Society Meeting according to the company’s press release, treatment-naïve DME patients (n=26) who received Restoret monotherapy and treatment-naïve AMD patients (n=5) who received Restoret and aflibercept showed BCVA improvement (a mean of 11.2 letter improvement in the DME group) and a reduction in retinal thickness (a mean reduction of –143 microns in the DME group). Restoret was well tolerated in both groups, according to the company. Restoret is described as an “investigational tri-specific Wnt agonist antibody … [that] aims to eliminate leakage in vascular diseases by activating the Wnt pathway to both restore and maintain the blood-retinal barrier.”

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Study: Rapid eye stroke detection protocol helps prevent vision loss

Researchers from New York Eye and Ear Infirmary of Mount Sinai published a novel protocol that, according to a press release from the organization, can quickly detect eye stroke and lead to care that prevents irreversible blindness. The protocol, published in the journal Ophthalmology, uses high-resolution retinal imaging (OCT) in an emergency room setting and remote consultation with retina specialists. According to the press release, 59 patients went through the protocol described in the study in its first 18 months. The average time from onset of symptoms to treatment after confirmed diagnosis was 9 hours (treatment occurred within 2.5 hours after arrival at the hospital). Of the 25 patients with confirmed eye stroke, 10 were eligible for treatment and nine received treatment with intra-arterial tPA. Treatment resulted in patients’ vision improving from count fingers to 20/100; four patients who received treatment improved to 20/40 or better.

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Enrollment complete for Phase 3 trial for sozinibercept

Opthea completed enrollment for its Phase 3 pivotal clinical trial for sozinibercept (OPT-302), a VEGF-C/D inhibitor in combination with aflibercept (anti-VEGF-A) for treatment of wet AMD. The second Phase 3 clinical trial for sozinibercept is expected to complete enrollment within the second quarter of this year, the company reported. With that, Opthea expects topline results from its Phase 3 clinical program in 2025.

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ASCRS news and events

• ASCRS Annual Meeting: The ASCRS Annual Meeting has something for everybody, from symposia to courses and paper sessions to hands-on lab experiences to networking opportunities. See what to expect April 5–8 in Boston, Massachusetts, by reviewing the ASCRS ASOA Preview Program.
• ASCRS Foundation: The 2024 ASCRS Foundation Chang-Crandall Humanitarian Award recipient is Martin Spencer, MD. Read more about Dr. Spencer and his inspiring work in this press release.

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Research highlights

• A review published in the Journal of Cataract & Refractive Surgery discussed optimal dosing and adverse effects of intracameral phenylephrine for intraoperative mydriasis and management of intraoperative floppy iris syndrome (IFIS). The authors wrote that “serious systemic adverse events…have been described with topical phenylephrine drops,” but little evidence has implicated intracameral phenylephrine with similar adverse events. The authors speculated this could be due to adverse events in cases with intracameral phenylephrine potentially being attributed to other causes (anxiety, patient position, anesthesia). The authors suggest that with a lack of research on the optimal dose/concentration for intracameral phenylephrine, that a lower concentration (0.31%) should be used with an anticholinergic and lidocaine for mydriasis. For IFIS, this lower concentration could be effective, but the authors note that a higher concentration (1–1.25%) might be needed.
• A 6-week observational, extension study was conducted to evaluate the long-term outcomes of lotilaner ophthalmic solution, 0.25%, for treatment of Demodex blepharitis. The study published in the journal Cornea included 128 patients who received lotilaner and 111 who were in the control group. Patients received a 6-week treatment. At day 180, the percentage of patients with 0–2 collarettes was significantly higher in the study group than the control group (39.8% vs. 2.7%); at day 365 it was 23.5% vs. 2.9%. Patients with 10 or less collarettes was also significantly higher in the study group vs. control at day 180 and day 365 (70.3% vs. 18.0% and 62.6% vs. 21.9%, respectively). The authors reported continued improvement of erythema in the study group after the 6-week treatment and no serious adverse ocular events (there was one mild ocular adverse event in the treatment group).

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Product news

• Eyenovia successfully completed FDA inspection of its commercial manufacturing facility that will allow it to produce Mydcombi, a fixed-combination of tropicamide and phenylephrine (1%/2.5%) delivered with the company’s Optejet spray device for pupil dilation.

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