Topline results from Phase 2/3 study for uveal melanoma treatment

IDEAYA Biosciences and Servier announced positive topline results from their Phase 2/3 registrational trial for darovasertib in combination with crizotinib as a first line therapy for HLA-A*A2:01-negative metastatic uveal melanoma. The investigational treatment “met the primary endpoint of a statistically significant improvement in median progression-free survival (PFS) relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR).” The study included 210 patients who received darovasertib combination, and 103 received therapy based on the investigator’s choice (76% of which was ipilimumab plus nivolumab and 24% pembrolizumab). According to the company’s press release, patients in the darovasertib combination group reduced their risk of disease progression by 58%. The overall response rate in the darovasertib combination group and ICT group was 37.1% and 5.8%, respectively. Additionally, there were 5 complete responses in the investigational group; none were observed in the ICT arm. Median duration of response in the darovasertib combination arm was 6.8 months. Based on this data, as well as safety and tolerability data, the company plans to submit a New Drug Application to the FDA in the second half of 2026.

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Study evaluates spatial computing in cataract surgery with Apple Vision Pro

A prospective, IRB-approved feasibility study has begun to evaluate cataract surgery with Apple’s heads-up visualization technology (Apple Vision Pro), the ClearSurgery spatial application (developed by ClearSurgery), and the ZEISS Artevo 3D digital microscope. This study is being conducted by Sharp HealthCare and Sharp Otay Lakes Ambulatory Surgery Center in California. According to the company’s Chief Spatial Computing Officer, the study will “generate clinical data that helps us understand how spatial computing technology may be used safely in surgical eye care.”

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Updates in DME treatment trials

• Eclipse Life Sciences has completed patient enrollment for its Phase 2 clinical trial evaluating EC-104 (fluocinolone acetonide) as a 6-month extended-release intravitreal corticosteroid implant for treatment of DME. This U.S.-based trial compares two doses of the investigational corticosteroid implant to Ozurdex (dexamethasone intravitreal implant, 0.7 mg) in patients with DME who have had a poor clinical response to intravitreal anti-VEGF therapy and who have previously tolerated corticosteroids without significant IOP increases. The primary endpoint is safety; secondary endpoints evaluate anatomical durability of treatment response and BCVA at 24 weeks post-implant.
• Oculis announced final patient visits in its Phase 3 trials evaluating OCS-01 (dexamethasone) for treatment of DME. The company plans to report topline results in June 2026. The company’s Phase 3 program consists of two trials evaluating the safety and efficacy of OCS-01 drops in patients with DME, following them for 52 weeks. So far, OCS-01 has demonstrated significant improvements in visual acuity and rapidly reduced edema. An NDA submission to the FDA could be made in the fourth quarter of this year, according to the company’s press release.

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Company news

• MeiraGTx and Johnson & Johnson entered into a purchase agreement for MeiraGTx to acquire botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP), which is on the pathway toward regulatory approval. The company stated that it expects to file a BLA in the U.S. and elsewhere as soon as possible.

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ASCRS news and events

• ASCRS Annual Meeting: Hotel rooms are now available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location.
• EyeWorld Onsite: Did you miss content from the 2026 ASCRS Annual Meeting? Read live coverage and see photos from key symposia and events in EyeWorld Onsite.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2026. Registration is open for the next event in Omaha, Nebraska, on June 11.
• ASCRS Online Education: The ASCRS CME Education Catalog offers a wealth of both CME and non-CME content for ASCRS members. Check out what your colleagues have been watching lately.

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Research highlights

• The use and success rates of Merit-Based Incentive Payment System (MIPS) measure 191 criteria for cataract surgery was evaluated in a retrospective cohort study published in JAMA Ophthalmology. The study was designed to assess the validity and generalizability of 2024 MIPS measure 191, which is that patients achieve 20/40 or better within 90 days after surgery, according to the study authors. The study included data from patients (n=55,132) from 16 health systems who underwent at least 1 cataract surgery from 2010 through 2023. The authors found that among all patients who had surgery, 90.7% achieved surgical success, per MIPS measure 191. When excluding patients with ocular comorbidities, the success rate jumped to 95.5%. Patients who were considered to live in the least affluent community, who had complex surgery, who had cataract surgery combined with another intraocular procedure, or who had diabetes were less likely to achieve success under MIPS measure 191. The authors noted that while most patients achieved surgical success, “the existing measure excluded nearly half of patients undergoing surgery, and older patients and Black patients were more likely to be excluded.” They suggest a “case-mix adjustment of patients’ sociodemographic characteristics and clinical factors […] to ensure fairness when comparing surgeons’ performance.”
• The role of toric IOLs in keratoconic eyes undergoing cataract surgery was evaluated using a statistical eye model, which generated 20 keratoconic eye situations for optical simulation. Ray tracing and comparative analysis of image quality were assessed. According to the study authors, the eye simulations underwent simulated corrections with spherical and toric IOLs and spherical and toric rigid gas-permeable (RGP) contact lenses. The authors found that “spherical and toric IOLs alone modestly improved [visual Strehl ratio, which was used to quantify image quality] to 0.025±0.004 and 0.034±0.005, respectively, from a baseline of 0.013±0.003 (P<.001).” However, eyes that were corrected with toric RGP lenses after IOL implantation had significantly better image quality—”0.250±0.014 (spherical IOL) and 0.246±0.014 (toric IOL) (P<.001).” Combining a toric IOL with a toric RGP, however, “led to overcorrection and increased aberrations,” the authors wrote. The study is published in the Journal of Cataract & Refractive Surgery.

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Product news

• CMS issued a permanent J-Code for Epioxa HD/Epioxa (riboflavin 5’-phosphate ophthalmic solution, 0.239%/riboflavin 5’-phosphate ophthalmic solution, 0.177%, Glaukos) for treatment of keratoconus. The code, J2789, will become effective on July 1, 2026.
• Lenz Therapeutics, which received FDA approval for VIZZ (aceclidine ophthalmic solution, 1.44%) in 2025 for treatment of presbyopia, submitted a Marketing Authorization Application for VIZZ in the U.K.
• BVI received the CE Mark for its phaco-vitrectomy platform Virtuoso.

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