New device for bladeless goniotomy

Sight Sciences introduced a new instrument for “bladeless,” “gentle” goniotomy—the SION Surgical Instrument. According to the company’s press release, this manually operated device excises the trabecular meshwork without cutting by using specialized lasers. As the press release stated, the instrument “grasps and removes diseased tissue as the surgeon sweeps the instrument around Schlemm’s canal.” A bladeless design removes the risk of a sharp instrument within the eye. This device is an FDA Class 1 510(k) exempt device, according to the company.

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FDA approves the first at-home digital vision test

The first online visual acuity test—the Visibly Digital Acuity Product (VDAP, Visibly)—received FDA 510(k) clearance earlier this month, making it the first FDA-approved, at-home vision test in the U.S. According to the company, this approval will “expand affordable access to vision care for millions of consumers.” The screener is on demand and self-administered, using a mobile device and computer with an internet connection. The test takes about 6 minutes to complete, according to the company, with results being sent securely to eyecare professionals.

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Alcon to acquire Aerie Pharmaceuticals

Alcon and Aerie Pharmaceuticals announced plans for the former to acquire the latter as they entered a definitive merger agreement. According to the companies’ press release, this acquisition would add Aerie’s FDA-approved Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil) and its dry eye candidate, AR-15512, which is currently in Phase 3 clinical trials, to its pharmaceutical portfolio. Phase 2 results for AR-15512 were recently published in peer review, finding that while the TRPM8 agonist did not meet the primary endpoints, which was change from baseline in ocular discomfort scores and anesthetized Schirmer score at day 28, it did achieve statistically significant improvements in dry eye disease signs, symptoms, and disease-related quality of life scores. The study can be found in the journal The Ocular Surface. The acquisition of Aerie by Alcon is expected to close in the fourth quarter of 2022, according to the press release.

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Study: Phase 2 trial for investigational dry eye therapy meets primary endpoint

Oculis announced publication of its Phase 2 clinical trial assessing licaminlimab (OCS-02) on ocular discomfort in patients with severe dry eye disease. The study, published in the peer-reviewed journal Clinical Ophthalmology, showed that a greater percentage of patients at day 29 who used topical licaminlimab compared to vehicle had improvements in ocular discomfort scores compared to baseline. The drug was well tolerated with no safety differences compared to vehicle. The company’s press release about the study described licaminlimab as a single-chain antibody fragment that binds to and neutralizes TNFα, acting as an anti-inflammatory and anti-necrotic agent.

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ASCRS news and events

• ASCRS Annual Meeting: The call for abstract submissions for the 2023 ASCRS Annual Meeting is open now through October 14.
• ASCRS app: Have you downloaded and logged in (use your ASCRS ID or create one) to the new ASCRS app? Learn more about the app and how to download here.
• ASCRS Summer Meeting recap: EyeWorld Onsite covered the ASCRS Summer Meeting, which took place August 19–21 in Nashville, Tennessee. Read recaps from the programming here and here.

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Research highlights

• A retrospective study sought to evaluate whether biometric measurements of corneal curvature (mean K values) from a fellow eye could be used to substitute lens power calculations in eyes with severe corneal pathology where measurements could be challenging. The study also evaluated whether similarity in axial length between a patient’s eyes could imply similarity in corneal curvature. The study included optical biometry measurements of 500 adults (1,000 phakic eyes) scheduled for cataract surgery. A similar axial length was defined as a less than 0.3 mm difference between the two eyes. According to the research, the IOL power calculated with the K mean from the fellow eye was 0.39 D different than the calculation with both the axial length and K mean from the correct eye. The researchers found a more than 1 D difference in 26 of the eyes (5%). The authors concluded that K values from the fellow eye were an adequate substitute for lens calculations for patients with incomplete keratometry readings. A similar axial length between the two eyes, however, did not imply that corneal curvatures were more similar. This research is published in the journal Clinical Ophthalmology.
• Use of cyclosporine for prevention of early graft failure after therapeutic penetrating keratoplasty (TPK) in eyes with fungal keratitis was evaluated in a prospective case series. The series included patients with fungal keratitis who underwent TPK from May–December 2019. These participants (n=20) were compared to a historical cohort (n=28) treated with prednisolone acetate 1% drops. There were 10 clear grafts at 3 months postop in the group treated with cyclosporine, compared to 4 in the cohort that received conventional therapy drops. Mean BCVA was better in the cyclosporine group as well (1.49±0.74 vs. 2.10±0.62). There was no reoccurrence of primary fungal infection in the group that received cyclosporine drops post-TPK, compared to 5 in the group that received conventional therapy (4 of whom in this set were on topical prednisolone). The investigators concluded that topical cyclosporine seems to increase graft survival and reduced risk of recurrence of fungal infection. The research is published in the journal Cornea.

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