52-week Phase 3 data published for cyclosporine, 0.1%

Harrow announced publication of the results from its Phase 3 open-label extension study for VEVYE (cyclosporine ophthalmic solution), 0.1%, for the treatment of signs and symptoms of dry eye. According to the company’s press release, the study, which included 202 patients, showed a statistically significant improvement in all efficacy endpoints compared to baseline at each visit. Corneal staining improvements were observed early, according to the paper published in the journal Cornea, and stabilized over time; tear production improved continuously during the study period. The most common adverse event was mild instillation site pain in 6.5% of the 175 patients who completed follow-up. The company noted in a press release that when patients were asked to rate on a scale from 0 to 10 how satisfied they were with the drop, 33.1% rated at a 10; 91% rated at a score of 5 or higher.

Back to top

First patient enrolled in Phase 3 trial assessing new treatment for MGD

Azura Ophthalmics announced that it enrolled its first patient in its Phase 3 clinical trial assessing the safety and efficacy of AZR-MD-001 for patients with signs and symptoms of MGD. The multicenter, double-masked, vehicle-controlled randomized trial will evaluate safety, efficacy, and tolerability of AZR-MD-001 sterile ophthalmic ointment, 0.5%, vs. control dosed twice weekly in about 500 patients for 12 months. Primary efficacy sign is change from baseline to month 3 in the meibomian glands liquid secretion. The primary efficacy symptom is change from baseline to month 3 in OSDI score. Secondary endpoints will include change from baseline in SPEED scores and the treatment’s ability to improve additional signs and symptoms. AZR-MD-001 is designed to be applied to the lower eyelid and is, according to the company, thought to “[break] down the bonds between abnormal keratin proteins to soften glandular blockage, [slow] down the production of keratin to prevent future blockages, and [increase] the quality and quantity of meibum produced by the meibomian glands.”

Back to top

Geographic atrophy treatment trial advances to highest dose

Ocugen announced that it was moving toward dosing patients with its highest dose of OCU410 for treatment of geographic atrophy. According to the company’s press release, six patients with geographic atrophy have received a low dose and medium dose of the gene therapy to date in the Phase 1/2 clinical trial. The company stated that it was approved to move to dosing at the highest level in the dose-expansion phase and to begin Phase 2 dosing due to no serious adverse treatment-related events. The company described the studies as assessing safety and efficacy of unilateral subretinal injection of OCU410. Phase 1 is the dose-ranging study while Phase 2 will randomize patients in an outcome accessor-blinded, dose-expansion study where patients will be placed into one of two OCU410 treatments groups or the untreated control group.

Back to top

New dataset added to support various areas of research and development

Verana Health announced the launch of its Qdata Uveitic Macular Edema module, which the company noted includes visual acuity, central subfield thickness, and IOP information and nearly 4 years of follow-up data on more than 152,000 de-identified patients. Verana stated that this dataset is a “major advancement in the management and treatment of UME, a prevalent complication of uveitis that leads to significant visual loss.” The data can help support clinical development, economic and outcomes research, and therapy development, and identify real-world treatment patterns and outcomes, and site selection and patient identification for research. Verana has also recently began development of Qdata Dry Eye Disease and Qdata Thyroid Eye Disease for additional research capabilities.

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, on June 13. Register now.
• 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.
• 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

• The visual and refractive outcomes and patient satisfaction with bilateral implantation of an enhanced monofocal IOL (RayOne EMV, Rayner), targeted for emmetropia, was reported in a prospective, monocentric, non-comparative study published in the Journal of Cataract & Refractive Surgery. The study included 50 eyes of 25 patients who had less than 1.5 D of astigmatism. At month 3, the mean manifest spherical equivalent was −0.39±0.28 D, and all eyes were within 1 D of target. Sixty-eight percent of patients could read ≤0.0 logMAR and 95% ≤0.2 logMAR for distance binocularly uncorrected, and 59% could read ≤0.1 and 100% ≤0.2 logMAR at intermediate. Ninety-six percent of patients were satisfied with their lenses.
• The need for YAG capsulotomy within 5 years after cataract surgery with different single-piece, acrylic monofocal IOLs (AcrySof [Alcon], LLASY60 [AJL], Bi-flex [Medicontur], Stabibag [IOL Tech], and Asphina [Carl Zeiss Meditec]) was evaluated in a Spanish cohort study published in the journal Clinical Ophthalmology. The study, which was based on EMR data, included 9,545 patients with 14,519 eyes; 3,955 eyes had follow-up data out to 5 years available for analysis. In this timeframe, YAG incidence, according to the study, was lower with the AcrySof IOLs (8.8%) compared to the others, which were as follows: LLASY60 47.4%, Asphina 44.3%, and Stabibag 44.0%. This, the authors concluded, highlights “the importance of IOL choice for patients’ long-term outcomes.”

Back to top

Product news

• CorneaGen announced the commercial launch of Corneal Tissue Addition for Keratoplasty (CTAK) for corneal contouring in eyes with keratoconus. This product was developed in partnership with CTAK LLC and Ziemer.
• The CIRRUS 6000 OCT (Carl Zeiss Meditec) is now available in the U.S.
• BioTissue introduced the CAM360 AG, a hydrated, shelf-stable cryopreserved amniotic membrane solution for treatment of ocular surface disorders.
• Nidek launched the RS-1 Glauvas OCT system.
• Nordic Pharma launched LACRIFILL Canalicular Gel, a crosslinked hyaluronic acid derivative, which has FDA approval to temporarily block tear drainage by the occlusion of the canalicular system.
• Quantel Medical launched the POCKET III handheld pachymeter, which has the CE mark and FDA 510(k) approval.

Back to top

---