Last patient visit in proof-of-concept cell therapy

Emmecell completed its last patient visit in the Phase 1 proof-of-concept expansion study of a cell therapy for corneal edema. This study is a 21-patient, randomized, double-masked, U.S.-based, multicenter trial to assess EO2002 for treatment of corneal edema. EO2002 is described as a “first-in-class, non-surgical cell therapy incorporating Emmecell’s exclusive Magnetic Cell Delivery (MCD) nanoparticle platform.” Preliminary data from the trial showed improvement in BCVA, reduction in corneal thickness, and safety. The company reported that additional topline results are expected in November.

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Phase 2 data for allergic eye inflammation drop published

Marinomed Biotech announced publication of its Phase 2 data for Tacrosolv eye drops (tacrolimus eye drop solution, 0.005%) for treatment of allergic rhinoconjunctivitis. The results, published in the journal Clinical Ophthalmology, showed that the high dose (5 μg) was safe and effective at alleviating symptoms. One day 8, this dose reduced total ocular symptom scores compared to placebo. There was a 26% reduction in baseline adjusted total ocular symptom scores from day 1 to day 8 in patients treated with this dosage. Participants in the placebo group showed no difference in total ocular symptom scores between day 1 and day 8.

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NDA resubmission to the FDA for topical ocular reproxalap

Aldeyra Therapeutics resubmitted a New Drug Application (NDA) to the FDA for topical ocular reproxalap for treatment of signs and symptoms of dry eye. This resubmission, according to the company, “includes previously disclosed positive results from a recently completed dry eye disease symptom trial requested by the FDA following review of the previously submitted NDA, as well as a draft label reflecting acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials.”

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Positive topline results from Phase 2b suprachoroidal wet AMD therapy

Clearside Biomedical announced positive topline results from its Phase 2b study evaluating suprachoroidal administration of CLS-AX (axitinib injectable suspension) for treatment of wet AMD. According to the company’s press release, the treatment achieved both primary and secondary outcomes with BCVA and central subfield thickness remaining stable up to 9 months, compared to patients who received aflibercept (control). There were no ocular or treatment-related serious adverse events, and 67% of CLS-AX participants did not require additional treatment up to 6 months. The company reported that the reduced treatment burden in the study group was 84%.

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Complimentary access to video journal

The latest issue of the Video Journal of Cataract, Refractive, & Glaucoma Surgery, founded and edited by Robert Osher, MD, is online now, focusing on highlights from an ESCRS video symposium. Dr. Osher recently received a Lifetime Achievement Award at the 2024 Congress of ESCRS.

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Partnership news

• CASExGLOBAL partnered with Clinical AI and iOR Partners to “introduce AI-powered, decentralized clinical trials to ophthalmic [office-based surgery] centers.”
• Topcon Healthcare and BeeKeeperAI entered into a collaboration that will allow Topcon’s digital health information platform, Harmony, to leverage BeeKeeperAI’s EscrowAI to “accelerate the strategy of applying AI models to imaging data from the eye, facilitating earlier detection and better management of disease” with privacy-enhanced capabilities.

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ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery (BRiCS) Summit: ASCRS held the inaugural BRiCS Summit on September 27 and 28. Read the recap in EyeWorld Onsite.
• 2025 ASCRS Annual Meeting: Registration is now open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2024. Registration is open for the events in San Diego, California, on November 7 and Charlotte, North Carolina, on November 14.
• ASCRS Foundation: Nominations are open for the Resident Excellence Award, which awards 10 exemplary residents a travel grant, 4 nights’ accommodation, complimentary registration, and invitations to leadership and social events at the 2025 ASCRS Annual Meeting.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

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Research highlights

• The predictive factors for redislocation of IOLs in patients who had recurrent IOL dislocation after secondary scleral-fixated IOL (SF IOL) surgery was investigated in a retrospective case series at two tertiary referral hospitals. The study included 237 eyes of 225 patients. The redislocation group was more likely to have a younger age during the initial SF IOL surgery compared to those who did not have a redislocation. Prior history of previous suture break and the initial SF IOL surgery using a less than 1 mm sideport incision were also more likely to have redislocation. Multivariate regression analysis showed “younger age, left eye involvement, aphakic status before the surgery, unremarkable primary IOL dislocation cause, need for ocular hypertension treatment and glaucoma surgery, and no large incision during the initial surgery were significantly (all P<.05) associated with redislocation.” This research was published in the Journal of Cataract & Refractive Surgery.
• The risk factors associated with development of ocular complications due to herpes zoster ophthalmicus (HZO), as well as the frequency of herpes zoster reactivation following shingles vaccination, was reviewed in a retrospective cohort study in a large hospital system. The study published in the American Journal of Ophthalmology included 3,283 patients with herpes zoster; HZO with ocular involvement was seen in 3.4% of patients. Within these, ocular complications occurred 36.4% of the time, with the most common being corneal scaring. Age, female gender, steroids given at the initial visit, and stromal keratitis were associated with developing an ocular complication. In the review, 5,333 patients received shingles vaccination, and 43 patients had herpes zoster reactivation following vaccination.

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Product news

• Verana Health introduced its Qdata Explorer as a “subscription-based tool that allows life sciences companies to explore Qdata, which are research-ready data modules that utilize exclusive, expertly-curated electronic health record (EHR) data from the Academy’s IRIS Registry.”
• Harrow relaunched FDA-approved TRIESENCE (triamcinolone acetonide injectable suspension), 40 mg/mL, for “visualization during vitrectomy and for the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.” This relaunch comes after the drug was on the FDA’s Drug Shortage List for 5 years and an inventory depletion of 2 years.

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