Results from second Phase 3 pivotal trial for presbyopia drop

Opus Genetics announced positive topline results from its second Phase 3 pivotal trial evaluating phentolamine ophthalmic solution, 0.75%, for treatment of presbyopia. According to the company’s press release, the trial met its primary endpoint, with a statistically significant 27.2% of participants treated with the drop achieving a 15 or greater letter improvement in DCNVA; the participants experienced a less than 5 letter loss in BCDVA at 12 hours post-dose on day 8. Only 11.5% of patients on the placebo drop achieved this result. A 15 or greater letter gain in DCNVA at 1 hour post-dose on day 1 was achieved in 20.6% of participants in the phentolamine arm compared to 6.1% in the placebo arm. Safety was consistent with that of previous trials; the most common treatment-related adverse events were conjunctival hyperemia, instillation site irritation, dysgeusia, and headache. The company reported that adverse events were “predominantly mild.” Long-term safety will be monitored out to 48 weeks.

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Interim Phase 2 data presented on DME, wet AMD treatment

Ashvattha Therapeutics announced presentation of its interim Phase 2 results evaluating subcutaneous migaldendranib for treatment of diabetic macular edema and wet AMD. The results demonstrated safety and sustained efficacy through 24 weeks in 19 patients (11 of whom had wet AMD and 8 DME). Patients with DME had an increase in BCVA of 4.5 letters and a decreased central subfield thickness of –69.1. Wet AMD patients maintained a stable BCVA and central subfield thickness. The company’s press release reported that the subcutaneous delivery is thought to be more patient friendly compared to intravitreal injections. The company also observed a 75% treatment burden reduction compared to treatment in fellow eyes, suggesting the potential for bilateral benefits with subcutaneous administration.

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Phase 2 trial to investigate oral DME treatment

Boehringer Ingelheim announced the beginning if its Phase 2 trial evaluating the efficacy, safety, and tolerability of BI 1815368, an investigational oral treatment for diabetic macular edema. The treatment is “intended to ameliorate retinal vascular hyperpermeability, thus treating existing exudation and preventing future exudation.”

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First patient dosed in investigational cell therapy for photoreceptor diseases

BlueRock Therapeutics announced that the first patient was dosed in its first-in-human Phase 1/2a trial evaluating OpCT-001, an investigational induced pluripotent stem cell therapy for the treatment of primary photoreceptor diseases, such as retinitis pigmentosa and cone-rod dystrophy. According to the company’s press release, the trial is a two-part interventional trial, with Phase 1 focusing on safety and dose-escalation and Phase 2 gathering additional safety data as well as assessments on the effect of the treatment on visual function, functional vision, and anatomic measures.

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Phase 1 trial begins for minimally invasive dry AMD treatment

PulseSight Therapeutics announced that it dosed the first patient in its Phase 1 clinical trial assessing safety and tolerability of PST-611. The treatment is described by the company as a “first-in-class non-viral vectorized therapy … expressing human transferrin, a highly potent iron regulator, playing a central role in restoring normal iron homeostasis.” The company explained that dry AMD involves dysregulation of iron homeostasis, which can lead to inflammation, oxidative stress, and retinal cell death. The Phase 1 study will enroll 6–12 patients with dry AMD. Preliminary results are expected in early 2026.

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Acquisitions and other company news

• Alcon announced its plans to acquire LumiThera, the maker of a photobiomodulation device for treatment of dry AMD.
• LENZ Therapeutics and Théa announced an exclusive license and commercialization agreement to register and commercialize LNZ100 for treatment of presbyopia in Canada. LNZ100, an aceclidine-based eye drop, has an August 8 PDUFA date in the U.S.
• Eyenovia announced its rebranding to the name Hyperion DeFi, a name which, according to the company’s press release, “reflects company’s leadership position with its cryptocurrency treasury reserve strategy focused on the HYPE token.”

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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 premium 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 Seattle, Washington, on July 24.
• 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 open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026. The call for submissions is also ongoing until September 1. Submit an abstract and get involved in ASCRS 2026.

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Research highlights

• Long-term changes in endothelial cell loss in different areas of the cornea after FLACS or conventional phacoemulsification cataract surgery was evaluated in a single-center retrospective study. The study included 48 eyes in the conventional phaco group and 40 eyes in the FLACS group. All patients were followed at 1 month, 3 months, 6 months, 12 months, and 24 months postoperatively. Endothelial cell loss was greater at position 2 (that nearest to the main corneal incision), while positions 1 (the corneal center) and 3 (the peripheral region opposite the main wound) remained stable at all time points. At postop month 3, the FLACS group had significantly lower endothelial cell loss at position 3 compared to the phaco group, but at position 2 endothelial cell loss increased in both groups, stabilizing at 6 months. There were not significant differences in coefficient of variation, percentage of hexagonal cells, or corneal thickness between the FLACS and phaco groups. The study is published in the Journal of Cataract & Refractive Surgery.
• A cross-sectional research study published in the journal Eye used data from the 2005–2008 National Health and Nutrition Examination Study and evaluated the effect of an antioxidant-rich diet on glaucoma prevalence. The study included participants 20 years or older who completed the dietary intake and vision and eye health questionnaire. A dietary oxidative balance score (DOBS) was calculated from 16 dietary factors. The study included 4,909 participants and found via logistic regression analysis that each unit increase in DOBS was associated with a 4% decrease in glaucoma risk. Other statistical analyses also significantly associated a higher DOBS score with a lower prevalence of glaucoma, suggesting a benefit for an antioxidant-rich diet in glaucoma prevention.

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Product news

• Corza Medical announced expansion of its Onatec Ophthalmic Suture Portfolio, which includes ophthalmic and oculoplastic absorbable and non-absorbable sutures.
• Regener-Eyes announced closure by the FDA of its voluntary product recall, returning products to normal operations. The company noted that the recall was out of an abundance of caution and resulted in a change in bottle design to include advanced backflow prevention technology to reduce microbial contamination.

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