Topline results for investigational first-in-class dry eye drop

Telios Pharma announced topline results for its TL-925, a first-in-class topical Bruton’s tyrosine kinase inhibitor for treatment of moderate to severe dry eye disease. The proof-of-concept study, which included 107 participants, compared safety, tolerability, and efficacy of TL-925 applied twice daily for 28 days to a vehicle control. The study found TL-925 to be safe and well tolerated with a clinically meaningful and statistically significant efficacy compared to vehicle. According to the company’s press release, a Phase 2b study has been initiated and is enrolling. According to EyeCRO, TL-925 incorporates MiDROPS, which is designed to increase bioavailability of the medication. A separate Phase 2 study is evaluating TL-925 for treatment of allergic conjunctivitis.

Back to top

Dosing complete in second cohort of Stargardt disease gene therapy trial

Ocugen announced that it completed dosing of a second cohort in its Phase 1/2 clinical trial of OCU410ST for Stargardt disease. OCU410ST is a modifier gene therapy candidate considered a first-in-class therapy for Stargardt disease that has the potential to be a one-time treatment. The second cohort is a medium dose. Following a review of 4-week safety data from this medium dose cohort, the company plans on advancing to a high-dose cohort that will include 3 patients.

Back to top

Enrollment complete for Phase 2 acute optic neuritis trial

Oculis announced that enrollment for its Phase 2, multicenter, randomized, double-blind, placebo-controlled trial evaluating safety and tolerability of OCS-05 for acute optic neuritis is complete. According to the company’s press release, OCS-05 has an orphan drug designation for this indication in both the U.S. and Europe. It is designed to be administered once daily via IV infusion. An ongoing study is taking place in four sites in France. The company hopes to submit an IND in the U.S. later this year.

Back to top

Enrollment complete for Phase 1/2a trial evaluating neovascular AMD therapy

AsclepiX Therapeutics announced that it completed enrollment of 15 patients for its Phase 1/2a open-label, single-ascending dose study to evaluate the safety and bioactivity of AXT107 (gersizangitide), administered via suprachoroidal injection, for patients with neovascular AMD. Topline results from the trial are expected in the second quarter of 2025. The company stated in a press release that AXT107 “inhibits pro-angiogenic vascular endothelial growth factor receptor 2 and activates the vessel stabilizing receptor tyrosine kinase.” The company also stated that due to low aqueous solubility, AXT107 is expected to have sustained durability, which could reduce treatment burden. The Phase 1/2a trial will evaluate three dose strengths of the treatment and determine bioactivity and duration, as well as assess central subfield thickness and BCVA.

Back to top

ASCRS news and events

• ASCRS Live!: This dinner series, making its way to nine cities, is continuing to bring ASCRS education around the U.S. Next up: Houston, Texas.
• 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 from April 2024 through April 2025 for a new video.
• ASCRS Annual Meeting: Hotel blocks are open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025.

Back to top

Research highlights

• Refractive surgery with or without prophylactic crosslinking was compared in a systematic literature review published in the Journal of Cataract & Refractive Surgery. The authors included 2,820 eyes from 23 studies and compared refractive surgery alone and refractive surgery with crosslinking. Refractive surgery combined with crosslinking decreased central corneal thickness, CDVA, and safety and efficacy indices, according to the authors. They noted no significant differences in postop UDVA of 20/20 or better at 12 or more months postop between the two groups. The authors wrote that more randomized control trials with standard crosslinking protocols are needed to review the prophylactic use of crosslinking with refractive surgery.
• The real-world clinical outcomes of in-office (slit lamp) administration of a bimatoprost sustained-release implant for IOP lowering was reported in a retrospective interventional case series published in the journal Clinical Ophthalmology. According to the paper, the study included 129 eyes of 81 patients who received the implant as an alternative to a topical prostaglandin analogue. It took 6–9 months post-implant before further glaucoma interventions were needed. Mean IOP was unchanged from baseline at month 1 and began to rise after month 3, the authors reported. At 1 year, 40.5% of eyes were intervention-free, mean topical medication reduction was 0.5 per eye, and 27.8% of eyes were medication-free. The authors noted that these real-world findings are similar to those of the Phase 3 study findings.

Back to top

Product news

• The ArcScan Insight 100, an ophthalmic ultrasound imaging system, received approval in China.

Back to top

---