FDA approves ophthalmic spray for mydriasis

Eyenovia announced FDA approval of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) for mydriasis delivered by the company’s proprietary Optejet drug delivery device. According to the company’s press release, this is the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S. and the first product approved using the company’s Optejet device. Mydcombi is indicated to induce mydriasis for diagnostic procedures and conditions where short-term pupil dilation is desired. It is contraindicated in patients with a known hypersensitivity to any component of its formulation.

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FDA accepts NDA for travoprost intraocular implant

Glaukos announced FDA acceptance of its NDA for iDose TR (travoprost intraocular implant). The NDA is supported by the company’s two Phase 3 pivotal trials, which both achieved pre-specified primary efficacy endpoints through 3 months and favorable tolerability and safety through 12 months. The PDUFA goal date for completion of the FDA’s review is December 22.

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FDA accepts supplemental BLA for treatment for macular edema

Genentech announced that the FDA accepted its supplemental Biologics License Application (BLA) for Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion. This application is based on the results from two Phase 3 studies that showed treatment with Vabysmo provided early, sustained improvement of vision in these cases and non-inferiority in visual gains at 24 weeks compared to aflibercept. These studies are ongoing out to 72 weeks, assessing the potential for extending dosing intervals up to every 4 months. Vabysmo is already approved in the U.S. for treatment of wet AMD and diabetic macular edema.

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FDA 510(k) clearance granted to green pattern laser photocoagulator

Norlase received FDA 510(k) clearance and the CE Mark for its ECHO Green Pattern Laser photocoagulator. According to the company, this is an industry-first, portable scanning laser photocoagulator that can increase accessibility of the technology.

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NDA submitted for pain and inflammation nanoemulsion

Salvat Laboratories submitted an NDA to the FDA for clobetasol, a corticosteroid formulated into a nanoemulsion for treatment of pain and inflammation after ocular surgery. The submission is based on two Phase 3 clinical trials. According to the company’s press release, after a standard 14-day treatment course, there was no rebound effect and thus no need for a gradual decrease in dosage. The company stated that there is not a need to shake the product due to the nanoemulsion formulation.

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Positive clinical results from IOP-monitoring contact lens

Smartlens announced positive clinical results for its miLens, an electronics-free soft contact lens for monitoring IOP. The study evaluated accuracy and comfort and compared results to the Goldmann tonometer. According to the company’s press release, the miLens measured changes in IOP that matched the Goldmann IOP values, which the company stated validated its ability to monitor IOP over time. The company reported 78% of miLens measurements were within 2 mm Hg of Goldmann.

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Study provides real-world data comparing MIGS using IRIS Registry

Sight Sciences announced 12-month retrospective subanalysis of IOP-lowering medication use after MIGS in patients with mild glaucoma. According to the company’s press release, the data from the American Academy of Ophthalmology’s IRIS Registry included 16,789 patients who received either 1) OMNI Surgical System (Sight Sciences) in combination with cataract surgery, 2) iStent Inject (Glaukos) in combination with cataract surgery, 3) Hydrus (Alcon) in combination with cataract surgery, or 4) cataract surgery alone. The analysis found that patients who had OMNI had “the greatest average medication reduction with a mean reduction from baseline of 1.01 glaucoma medications at 12 months postoperatively.” According to the company, this analysis was performed in partnership with Verana Health, the analytics partner of the IRIS Registry.

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FDA approves IOL positioning system

Centricity Vision announced that the FDA granted 510(k) clearance to its ZEPTOLink IOL Positioning System. According to the company’s press release, this platform integrates with any phaco system. The IOL positioning system is designed to increase precision of IOL positioning by creating centered, 360-degree IOL overlap. This news is an update from a post in EyeWorld Weekly last week that incorrectly stated that this technology was still under development.

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ASCRS news and events

• ASCRS Annual Meeting: Catch up on events from the ASCRS Annual Meeting by reading EyeWorld Daily News and on ASCRS social media platforms. Housing is now open for ASCRS 2024 in Boston, Massachusetts.
• ASCRS Summer Meeting: The ASCRS Summer Meeting in Nashville, Tennessee, returns August 11–13. Registration is open now.
• New webinar: The latest YES Connect Webinar—Refractive Surgery 101: Pearls for Getting Started with LASIK/PRK/SMILE/ICL/RLE—is online now.

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Research highlights

• The safety and efficacy of an eight-chop phaco technique was described in a paper published in the Journal of Cataract & Refractive Surgery. According to the prospective study, patients were classified into three groups based on their cataract grade (II, III, and IV, with 50 patients in each group). The eight-chopper I was used for Grade II, eight-chopper II for Grade III, and Lance-chopper for Grade IV. The paper reported a significant difference in phaco time, cumulative dissipated energy, and volume of fluid used among the three groups, increasing with denser lenses. The paper reported endothelial cell loss of 0.9%±5.9%, 1.0%±10.3%, and 5.3%±11.1% in the grade II, III, and IV groups at 19 weeks postoperatively, respectively. The author concluded that the eight-chop technique was safe and effective for nuclei of varying densities.
• A retrospective study published in the journal Ophthalmology sought to evaluate outcomes and incidence of adverse events in patients who had bilateral same-day refractive lens exchange. The procedures were performed by a private provider in the U.K. between March 2018 and December 2021. According to the paper, 17,330 patients (34,660 eyes) were included; 28,827 eyes received a multifocal IOL and 5,833 a monofocal IOL. The percentage of eyes within 0.5 D of target was 85.5% with a monofocal and 86.2% with a multifocal, respectively. There were 55 intraoperative adverse events in 55 eyes of 54 patients, which the authors wrote is a 0.159% incidence. Posterior capsule tear was the most common adverse event. There were 267 adverse events within the first month postop for an incidence of 0.759%. The adverse events included cystoid macular edema (172 eyes), significant corneal edema (28 eyes), persistent inflammation (27 eyes), significantly raised IOP (27 eyes), TASS (8 eyes), wound leak (3 eyes), retinal detachment (1 eye), and retinal tear (1 eye). The authors reported the need for secondary surgical interventions in 56 cases in the first month postop; the most common reason was rotation of a misaligned toric IOL. The authors concluded that elective same-day bilateral refractive lens exchange was “safe, with high refractive predictability and a low incidence of serious adverse events.”

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Product news

• Harrow’s FDA-approved IHEEZO (chloroprocaine hydrochloride), a sterile, single patient-use ophthalmic gel for use as an ocular anesthetic, launched in the U.S. It has been issued the J-Code 2403 and transitional pass-through reimbursement status.

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