FDA OKs new drugs, indications, and devices

Recently, the U.S. Food & Drug Administration (FDA) announced a number of approvals and clearances that demonstrate the broad scope of innovation in the ophthalmic space. To help keep readers up to date, Ophthalmic Professional presents the following summary of the FDA approvals/clearances announced during the past several months:

Allergan, an AbbVie company, announced the FDA approved a twice-daily dosing option of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. A second dose may be administered 3-6 hours after the first dose. With the approval of twice-daily dosing, the duration of effect of VUITY may be extended for up to 9 hours.

Bausch + Lomb Corporation and Novaliq GmbH announced that the FDA has approved MIEBO (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO was approved based on results from two multi-center, randomized, double-masked, saline-controlled studies, GOBI and MOJAVE.

Eyenovia Inc.’s Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% received FDA approval for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. This represents the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.

Horizon Therapeutics announced the FDA has approved an update to the Indications and Usage section of the Tepezza label to specify its use for the treatment of “Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.”

Regeneron Pharmaceuticals announced the FDA approved EYLEA (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP). The FDA approval is supported by data from two randomized global Phase 3 trials — FIREFLEYE (N=113) and BUTTERFLEYE (N=120).

Novaliq GmbH announced FDA approval of VEVYE (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol) is the first cyclosporine solution indicated for the treatment of signs and symptoms of DED with efficacy demonstrated after four weeks of treatment.

C. Light Technologies, Inc. received word from the FDA that its Retitrack, a retinal eye-movement monitor for non-invasive, objective clinical assessments, has been cleared for marketing through premarket notification 510(k). The monocular eye movement monitor is intended for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses.

Centricity Vision received 510(k) clearance from the FDA for the ZEPTOLink IOL Positioning System. The platform integrates the ZEPTO precision pulse capsulotomy technology with any phaco system to streamline cataract surgery. ZEPTOLink uses suction and irrigation provided by the phaco system.

Johnson & Johnson Vision announced its ELITA Femtosecond Laser received FDA 510(k) clearance for the creation of LASIK flaps. ELITA provides low energy per pulse, fast laser repetition rate and small spot size (1 µm), smooth stromal bed, and sub-micron precision.

Norlase received FDA 510(k) clearance for the ECHO Green Pattern Laser photocoagulator, a portable scanning laser photocoagulator utilizing microelectromechanical systems technology. The laser and scanner are integrated into a single delivery device that attaches to compatible slit lamps.

Nova Eye Medical was granted FDA 510(k) clearance for its iTrack Advance canaloplasty device. iTrack Advance has been cleared for microcatheterization and viscodilation to reduce IOP in adult patients with primary open-angle glaucoma. The device leverages the same proprietary features of the company’s original iTrack but has been designed for improved surgical efficiency.

ZEISS Medical Technology announced the FDA approved the CT LUCIA 621P monofocal aspheric, single-piece C-loop IOL. The IOL features the ZEISS Optic Asphericity Concept, which is designed to compensate for a range of spherical aberrations and optimize visual outcomes in the event of potential decentration/lens misalignments.

The information presented was sourced from press announcements from the respective companies. Updates to this article will appear in the online version. OP