FDA approves first-in-class DED drop

Alcon received FDA approval for TRYPTYR, a first-in-class TRPM8 receptor agonist formerly known as AR-15512, that stimulates natural tear production for treatment of dry eye disease (DED). According to the company’s press release, this neuromodulator stimulates corneal nerves to increase natural tears. The FDA’s approval is supported by Phase 3 clinical trials that included 930 patients with dry eye disease who were randomized 1:1 to receive TRYPTYR or vehicle. According to the company, up to four times more patients receiving TRYPTYR experienced at least a 10 mm increase in tear production at day 14 compared to those on vehicle. These results were observed at all timepoints out to 90 days, and statistically significant natural tear production was seen as early as day 1. TRYPTYR will be available in single-dose vials for one drop per eye and is recommended two times a day. The U.S. launch is expected in the third quarter of this year.

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FDA accepts NDA for topical presbyopia therapy

The FDA accepted the New Drug Application for BRIMOCHOL PF submitted by Tenpoint Therapeutics for treatment of presbyopia. According to the company’s press release, BRIMOCHOL PF is a “novel pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia.” The PDUFA date is set for January 28, 2026.

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TFOS DEWS III

The Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS) III has published a series of articles in the American Journal of Ophthalmology. These include the TFOS DEWS III Digest Report, TFOS DEWS III Diagnostic Methodology, TFOS DEWS III Management and Therapy Report, and the TFOS DEWS III Editorial. According to a press release earlier this year from the society, the DEWS III is intended to update the recommendations of the DEWS II regarding subclassification, diagnostic methodology, and management and therapy of dry eye disease. The Digest is intended to “highlight new advances in other TFOS DEWS II topics, including epidemiology; sex, gender, and hormones; pathophysiology; tear film; pain and sensation; iatrogenic dry eye; and clinical trials.”

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Topline results in Phase 3 study evaluating night driving impairment after keratorefractive surgery

Opus Genetics announced topline results from its Phase 3 pivotal trial evaluating Phentolamine Ophthalmic Solution 0.75% for treatment of significant, chronic night driving impairment after keratorefractive surgery in patients with reduced mesopic vision. The primary endpoint (a gain of 3 lines [15 letters] or more of distance vision on a low contrast chart in low light conditions after 15 days of using Phentolamine Ophthalmic Solution) was achieved in 17.3% of participants; placebo achieved this endpoint in 9.2% of participants. The company’s press release stated that this was a statistically significant difference. The study also showed a patient-reported functional benefit with the investigational drop, and the safety profile was consistent with previous studies. This study, according to the company, was conducted under an FDA Special Protocol Assessment, and Phentolamine Ophthalmic Solution 0.75% has a Fast-Track Designation. The study will continue to monitor patients for long-term safety over 48 weeks.

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IND application submitted for pediatric myopia treatment

iVeena submitted an Investigational New Drug application to the FDA for IVMED-85 for treatment of pediatric myopia. Approval of the application would allow the company to begin a Phase 2 international study later this year. IVMED-85 is a preservative-free drop that, according to the company, “strengthens scleral and corneal collagen crosslinks through LOX activation, potentially leading to improved refraction and a decrease in the rate of axial elongation.”

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Study sheds light on clinical inherited retinal diseases without genetic mutations

Research from the University of Oklahoma College of Medicine is providing some information about patients with inherited retinal diseases (IRD) who test negative for genetic mutations. In the study intended to “improve diagnostic accuracy and advance understanding of disease mechanisms,” published in the journal Genes, the investigators performed genetic testing on 103 unrelated patients with an inherited retinal disease from a single site. Genetic findings were identified for 70 participants, 20 of which were novel variants. A press release about the study noted that 33 patients had no genetic mutations but still a clinical diagnosis. The researchers conducted further analysis on these genetic-negative patients, finding that 28 of the 33 had no family history of a similar eye disease. The study’s corresponding author, Lea D. Bennett, PhD, said in the press release the reasons for inconsistency between the clinical diagnosis and genetic testing could be mimicry of symptoms to another IRD, late-onset IRD, incomplete/undisclosed medical history, and/or an undiscovered gene or genetic mutation. In the press release, Dr. Bennet said this research could identify more treatment options and/or clinical trial candidates.

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ASCRS news and events

• Business of Refractive Cataract Surgery Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home resource library, will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Chicago, Illinois, on June 12.
• ASCRS Grand Rounds: A new episode of ASCRS Grand Rounds, featuring cases involving a challenging intraoperative cataract surgery complication and a referral for a corneal mass, is online now. Watch the episode, which is eligible for CME, here.
• 2026 ASCRS Annual Meeting: Hotel room blocks are now open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026.

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Research highlights

• A prospective observational study published in the Journal of Cataract & Refractive Surgery evaluated the visual, refractive, corneal topographic, and aberrometric results from the use of asymmetric intracorneal ring segments of variable width for the management of asymmetric keratoconus. The participants received 1 asymmetric intracorneal ring segment (AS ICRS, INTRASEG), which the study authors wrote has an arc length of 150 degrees and asymmetric width of 800–1200 μm. Forty-three eyes were analyzed in the study, which saw significant improvement of corrected distance visual acuity from 0.34±0.23 to 0.08±0.10 logMAR. The authors reported that the “flattening effect was higher at the widest end than the narrowest end (−10.59±2.59 diopters [D] vs −4.54±1.30 D, P<.001), contributing to reduce the Symmetry Index Front from 9.06±4.02 to 2.21±3.81.” Total higher aberrations were reduced. The authors concluded that the AS INTRASEG for asymmetric keratoconus could improve refractive, topographic, and aberrometric parameters.
• The long-term efficacy of cultured human corneal endothelial cell transplantation with ROCK inhibitors for treatment of corneal endothelial failure was investigated in a prospective observational study. The results of this study, which involved 65 patients who were followed for up to 10 years, were published in the journal Ophthalmology. The primary outcome was corneal restoration and transparency. Secondary outcomes were corneal endothelial cell density of more than 500 cells/ mm² and 1000 cells/mm², corneal thickness below 630 μm, and improvement in BCVA of 0.2 logMAR or more at 24 weeks and 5 years postop. Corneal transparency at 24 weeks, 5 years, and 10 years was achieved in 98.5%, 93.0%, and 83.7% of patients, respectively. Corneal endothelial cell density of more than 1000 cells/mm² was achieved in 79.6% of cases, and a corneal thickness of less than 630 μm was achieved in 85.4% of cases. BCVA improvement occurred in 85.7% of cases at 5 years postop. The authors reported no adverse reactions and concluded that long-term data found corneal endothelial cell transplantation to be safe and effective.

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