The latest in drug and technology developments and updates from July 2025.
What to take away in the worlds of presbyopia, lid and lash, retina, and dry eye from the past month. Image credit: AdobeStock/Shutter2U
Major news on the presbyopia forefront closed out July with the US Food and Drug Administration’s (FDA) approval of Lenz Therapeutics’ VIZZ (aceclidine 1.44%). The first and only FDA-approved aceclidine eye drop for presbyopia was met with other formative developments in multiple specialties in eye care, including retina, dry eye, and lid and lash. Learn the latest in our roundup of what to take away from the month of July in terms of drug and technology updates below:
Lenz Therapeutics has announced that the FDA has approved its formulation of aceclidine 1.44% for the correction of near vision in adults with presbyopia. This formulation is the first and only FDA-approved aceclidine eye drop indicated for presbyopia, and its unique mechanism of action relies on a pupil-selective miotic that interacts with the iris and recruits ciliary muscle minimally. In clinical trials, the formulation showed efficacy for up to 10 hours following instillation.
Today Nanoscope Therapeutics announced its rolling submission of a biologics license application (BLA) to the FDA for MCO-010 for the treatment of vision loss caused by retinitis pigmentosa (RP).1
Nanoscope’s BLA has been granted rolling review by the FDA, with the first modules already submitted. The completion of the full BLA submission is anticipated in early 2026 and is eligible for priority review under the program’s fast-track designation.
The FDA has accepted for review the resubmitted new drug application (NDA) for topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease from Aldeyra Therapeutics.1
Aldeyra resubmitted its NDA to the FDA in June 20252 after receiving 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.
In partnership with CorneaGen, Ziemer USA has launched its GALILEI CTAK module, now available for use with the GALILEI diagnostic platform.1 The module can be used in combination with Ziemer’s FEMTO LDV Z8 femtosecond laser platform, an all-in-one laser for refractive, cataract, and therapeutic surgery that can also be used for corneal tissue addition for keratoplasty (CTAK) procedures, according to a news release.
The module is now available in the US market, but will require a software update to existing GALILEI systems.
Viatris announced that its phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis did not meet the primary end point.
The MR-139 3001 phase 3 trial (NCT06400511) was a randomized, placebo-controlled, double-masked prospective study. A total of 477 patients were randomly assigned to receive either MR-139 or placebo, self-administered to the eyelids twice daily. Patients were treated and observed over 12 weeks.
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