FDA Orphan Drug and Fast Track Designations granted to investigational NK therapy

TearSolutions announced that it received an Orphan Drug Designation and a Fast Track Designation from the FDA for Lacripep, a first-in-class synthetic peptide derived from the tear protein lacritin. It is being developed as a treatment for neurotrophic keratitis (NK). In preclinical studies, Lacripep was used to “resolve underlying nerve damage, reactivate physiological basal tear secretion, and restore health to the corneal epithelium,” according to the company. TearSolutions has begun a Phase 2 clinical trial to evaluate safety and efficacy of Lacripep in about 54 patients diagnosed with neurotrophic keratitis.

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DME drop study does not meet Phase 3 endpoint

Oculis Holding announced topline results for its two Phase 3 trials evaluating OCS-01 drops for patients with diabetic macular edema (DME). The primary endpoint—mean change in BCVA ETDRS letter score at week 52—was not met in either trial, which in total included more than 800 patients among 119 investigational sites in the U.S. and outside the U.S. A secondary endpoint—retinal thickness measured by OCT—“showed a substantial and persistent reduction with OCS-01 vs vehicle at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1,” the company reported. However, the proportion of patients with a 15-letter gain or more in BCVA, which the company described as a “key secondary endpoint,” was not met in either trial. OCS-01 was described as well tolerated with no unexpected adverse events. Company leadership expressed disappointment over these results and said going forward they are focusing resources on their Privosegtor platform for optic neuropathies and licaminlimab for dry eye disease.

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Phase 1b trial begins for first-in-class DME treatment

Therini Bio began dosing the first patients in its Phase 1b trial for THN391 for treatment of diabetic macular edema. The company’s press release described THN391 as a “potential first-in-class, high-affinity, humanized monoclonal antibody designed to selectively block fibrin’s inflammatory epitope and halt the neuroinflammation cascade without disrupting coagulation.” It has already demonstrated efficacy as a VEGF antagonist, containing leakage from neovascular lesions in preclinical models. According to the company, the Phase 1b trial is a multiple ascending dose study that will assess safety and preliminary efficacy (retinal central subfield thickness, visual acuity, and exploratory biomarkers). Each patient in three dose cohorts will receive 3 monthly intravitreal injections of THN391. Data from this study is expected in the fourth quarter of 2026.

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ASCRS news and events

• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2026. Registration is still 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.
• 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.

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EyeWorld article of the week

Biologics are of interest for several corneal conditions. Winston Chamberlain, MD, PhD, Anat Galor, MD, and Stephen Pflugfelder, MD, described the appeal of biologics in the areas of immune-mediated and severe ocular surface disease, as well as corneal dystrophies. Read “Early momentum in biologics for corneal conditions” in the Spring issue of EyeWorld.

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Research highlights

• A longitudinal cohort study published online ahead of print in JAMA Ophthalmology sought to quantify what level of contrast sensitivity (CS) in older adults led to functional visual disability. According to the paper, “although poor CS is associated with falls, cognitive decline, and reduced independence in older adults, existing thresholds lack functional relevance,” which is what the research sought to correct. The study included data from the National Health and Aging Trends Study, which involved a nationally representative cohort of Medicare beneficiaries; 4,475 participants with binocular contrast sensitivity and self-reported vision data were included and exposed to logarithm-scaled, binocular presented contrast sensitivity (logCS). The authors found weighted mean logCS was 1.72. The baseline contrast sensitivity of people with self-reported visual disabilities (SRVD) was 1.49 logCS compared to 1.73 among those without SRVD. Those who developed a new SRVD within 1 year follow-up of the data collection showed a mean decline in logCS from 1.62 to 1.56. The authors noted that “each 0.1-unit decrease in baseline logCS was independently associated with a 12% higher odds of incident SRVD.” The threshold of 1.60 logCS was labeled as the “functional threshold” where the participants began to experience a SRVD.
• The correlation between preop vertex-scleral spur angle (Vtx-SSA) and postop horizontal IOL tilt after cataract surgery was evaluated in a postoperative case series from the Cullen Eye Institute at Baylor College of Medicine. The case series included 72 eyes of 72 patients. Vtx-SSA “was highly correlated with horizontal tilt,” the investigators found, noting that “tilting of the IOL in the horizontal axis accounted for nearly 80% of the total tilt magnitude.” A strong correlation was also identified between crystalline lens horizontal tilt and that of the IOL. No correlation was observed with axial length. The authors concluded that Vtx-SSA could be an “easy-to-interpret presurgical surrogate for estimating horizontal IOL tilt,” but added that “it does not account for more minor contributions of tilt in the vertical plane.” This research was published in the Journal of Cataract & Refractive Surgery.

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Product news

• Rayner launched its new Ophteis Cohesive OVD in European markets. The company stated that this launch is part of a comprehensive rebrand of its OVD products, which include Ophteis Cohesive, Ophteis Dispersive, and Ophteis Adaptive PRO.
• Bausch + Lomb launched Blink Triple Care Preservative Free lubricant eye drops in the U.S. The company stated it will be available at most retailers by the end of June.
• Samsung Bioepis launched OPUVIZ 40 mg/mL solution vials in Europe. OPUVIZ is considered a biosimilar to Eylea (aflibercept, Regeneron Pharmaceuticals).

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