Fast-Track Designation granted for persistent epithelial defect treatment

Kala Pharmaceuticals announced that it received a Fast-Track Designation from the FDA for its human mesenchymal stem cell secretome therapy called KPI-012 for the treatment of persistent corneal epithelial defect. According to the company, it dosed its first patient in a Phase 2b trial evaluating KPI-012 for this indication in February. By March, Kala announced positive safety data from its first cohort of two patients who were treated with a high dose of the product four times a day. A second cohort of 90 patients is now in a multicenter, randomized, double-masked, vehicle-controlled, parallel group study evaluating safety and tolerability of two doses compared to vehicle. The primary endpoint of this trial is complete healing of the epithelial defect measured by corneal fluorescein staining. Topline data is expected in the first quarter of 2024.

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Study: automated capsulotomy device and white cataracts

Centricity Vision announced publication of a study that showed its Zepto Precision Pulse Capsulotomy had advantages for capsulotomy creation in cases with white cataracts, compared to manual capsulorhexis creation. The study, published in the Journal of Cataract & Refractive Surgery, showed that Zepto produced a complete, consistently round capsulotomy without tears or tags; it quickly decompressed and reduced intralenticular pressure; there were no cases of an Argentinian flag sign; it reduced or eliminated use of trypan blue and cohesive OVD; it reduced the average procedural time by 1 minute; and there was 360-degree capsular overlap with IOLs in all cases. The study was retrospective based on surgical case records and videos from a single surgeon. It included 15 cases with white cataract (10 that were intumescent and 5 that were not intumescent) where a manual capsulorhexis was created and 20 cases (9 intumescent and 11 non-intumescent) where Zepto was used.

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Dose escalation complete for Phase 1/2 study evaluating an RP treatment

Endogena Therapeutics announced that it has completed dose escalation for its Phase 1/2 study of EA-2353 for treatment of retinitis pigmentosa. According to the company’s press release, EA-2353 uses a novel, small-molecule approach to selectively activate endogenous retinal stem and progenitor cells, which can then differentiate into photoreceptors to potentially preserve and restore visual function. The company describes it as a gene-independent treatment. In the current trial, there have been no clinically relevant or dose-limiting adverse events after repeated intravitreal injections. An expansion cohort will now take place at the highest dose evaluated to begin understanding efficacy of EA-2353.

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Companies enter agreement for sustained-release glaucoma treatment

Celanese and Glaukos have entered into an agreement to further development of a sustained-release glaucoma treatment. According to the company’s press release, Celanese will supply its VitalDose Drug Delivery Platform as a component of Glaukos’ iDose TR. iDose TR is a travoprost implant for which Glaukos submitted an NDA to the FDA in February (not yet approved).

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ASCRS news and events

• ASCRS Annual Meeting: Register for the ASCRS Annual Meeting, May 5–8, in San Diego, California. Check the ASCRS ASOA Real-Time Program for the latest program details.
• Eyecelerator: Registration is open for Eyecelerator @ ASCRS 2023. The innovation conference from ASCRS and the American Academy of Ophthalmology will be held on May 4 in San Diego, California. Join investors, industry leaders, and ophthalmologists at this showcase of companies, technology, and other exciting innovation topics in ophthalmology.

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Research highlights

• A study published in the Journal of Cataract & Refractive Surgery evaluated the outcomes of patients who had cataract surgery and were randomized to receive a non-diffractive EDOF IOL (AcrySof Vivity, Alcon) or a neutral aspheric monofocal IOL (enVista, Bausch + Lomb). The study was prospective, single center, double arm, and patient and assessor masked. The study enrolled 56 patients, 24 of whom received the EDOF IOL and 27 the monofocal. The EDOF IOL group saw CDVA, DCIVA, and DCNVA of 20/20, 20/19, and 20/21, according to the investigators, while the monofocal was 20/18, 20/31, and 20/30. Eighty-eight percent of patients in the EDOF group saw 20/25 or better at intermediate distance compared to 30% in the monofocal group. Moderate to severe glare was reported in 20.8% of EDOF patients and in 7.4% of monofocal patients; halo was 16.7% in the EDOF group and 11.1% in the monofocal group.
• A randomized, Phase 3 clinical trial sought to evaluate whether a twice-daily dosed, water-free cyclosporine drop (CycleASol, 0.1%, Novaliq) was effective at treating dry eye. The study, conducted from Dec. 5, 2020–Oct. 8, 2021, included 834 participants who were randomized to receive the cyclosporine drop (n=423) or vehicle (n=411). According to the paper, which is published in JAMA Ophthalmology, patients in the cyclosporine group had a greater improvement in total corneal fluorescein staining (–4.0 grades) compared to the vehicle group (–3.6 grades) at day 29. Dryness scores were –12.2 points in the cyclosporine group and –13.6 points for vehicle. More participants in the cyclosporine group (293, 71.6%) achieved a clinically meaningful reduction of 3 grades or higher in total corneal fluorescein staining, compared to 236 (59.7%) in the vehicle group. Those who responded to the cyclosporine treatment also showed a greater improvement in dryness symptoms and blurred vision at day 29, the authors reported. According to the investigators, this trial confirms the efficacy of water-free cyclosporine solution, 0.1%, with a clinically meaningful effect being seen in slightly more than 70% of participants who received the medication.

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Product news

• A preloaded DMEK EndoGlide is now available from Eversight.

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