Study: low-dose pilocarpine reduces pupil diameter without significant ciliary muscle response

Orasis Pharmaceuticals announced research that has found a “pupil selective” response to its low-dose pilocarpine formulation, 0.4% (Qlosi), without significant change in ciliary muscle movement. According to the company’s press release, the Qlosi formulation was compared head-to-head to balanced salt solution and a 2% pilocarpine formulation. OCT images were used to measure ciliary muscle movement, change in pupil diameter, and lens thickness. The study enrolled 10 patients with presbyopia (patients with prior ocular surgery or other ocular comorbidities were excluded). The researchers found that Qlosi significantly reduced pupil size without significant change in lens thickness or ciliary muscle response. The 2% pilocarpine formulation showed “significant change in ciliary muscle movement at near not observed in [balanced salt solution] or Qlosi groups.” This, the researchers stated in the press release, suggests that low-dose pilocarpine balances efficacy and safety. The company noted a favorable safety profile from its Phase 3 pivotal trials, in addition to 10 months of real-world use since product launch with no reported cases of retinal detachment or other serious adverse events.

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First patient receives investigational surgical system for glaucoma

Myra Vision announced that the first patient has been enrolled and received the Calibreye TGT Surgical System, an adjustable shunt for treatment of glaucoma. According to the company’s press release, this is considered the first shunt that could be adjusted postop at the slit lamp for individualized IOP management. The trial will enroll up to 70 patients with refractory glaucoma, evaluating safety and efficacy of this new system.

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Clinical program for RP gene therapy begins

Opus Genetics announced that it is beginning a clinical trial to evaluate a gene therapy to treat MERTK-related retinitis pigmentosa (RP). The study will take place in Abu Dhabi to assess the safety and efficacy of OPGx-MERTK, an AAV-based gene therapy designed to deliver a functional copy of the MERTK gene to retinal cells.

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FDA approves IND for steroid-free, topical anti-inflammatory

Novaliq had its Investigational New Drug (IND) application approved for NOV05 (tacrolimus ophthalmic solution) as a steroid-free, topical anti-inflammatory treatment of inner-eye diseases. With this IND, the company stated that it can begin a Phase 2 clinical trial for patients with non-infectious anterior uveitis. According to the company’s press release, oral tacrolimus was shown effective, but it has low bioavailability in eye tissues and carries some systemic side effects. Efficacy of topical tacrolimus for inner eye tissues has not yet been demonstrated.

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Compassionate use approved for investigational drug intended for neuropathic corneal pain

The FDA approved single-patient compassionate use of urcosimod 0.05% for severe neuropathic corneal pain. Currently, OKYO Pharma has a Fast Track designation from the FDA for urcosimod. It is expected to begin a multiple-dose Phase 2b/3 study to evaluate urcosimod for treatment of neuropathic corneal pain later this year.

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Company news

• BioTissue Holdings has completed the sale of its non-ocular surgical and wound care business to BioStem Technologies.

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ASCRS news and events

• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13. View the Preview Program for more information.
• SightLine at ASCRS: Connect, collaborate, and confront the challenges shaping the commercial landscape of ophthalmology at this meeting taking place Thursday, April 9 ahead of the ASCRS Annual Meeting. This meeting is for all commercial stakeholders in ophthalmology to learn about care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 9 ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• ASCRS and EyeSustain-endorsed position paper published: Chang et al. published a position paper in the latest issue of the Journal of Cataract & Refractive Surgery that emphasizes the unmet need for multiuse phaco machine products. Read the paper here.

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Research highlights

• Patient-reported pain perception with either immediately sequential or delayed sequential bilateral cataract surgery (ISBCS vs. DSBCS) was compared in a prospective cohort study published in the Journal of Cataract & Refractive Surgery. The study enrolled 45 patients for ISBCS and 45 for DSBCS. Pain scores, assessed with a verbal numeric rating scale of 0–10, among both groups right after surgery were low. The authors also reported “no significant impact of surgical methods on pain scores, with a notable decrease in pain levels over time.” However, they did find that length of the surgery significantly impacted pain perception and that patients with higher education levels reported higher pain scores. “The effect of education level on pain perception suggests the importance of good preoperative counseling to set appropriate expectations,” they concluded.
• The safety and efficacy of lotilaner ophthalmic solution, 0.25%, was compared to vehicle for patients with Demodexblepharitis and meibomian gland disease, based on pooled analysis of two prospective, randomized double-masked studies. According to the paper published in Clinical Ophthalmology, on day 43 and day 85, a statistically significant higher proportion of patients in the lotilaner group saw collarette reduction to grade 0 and grade 0–1, compared to those in the vehicle group. Patients in the lotilaner group also saw statistically higher meibomian gland secretion scores, number of glands yielding any liquid secretions, and number of glands yielding clear liquid secretions. More patients in the lotilaner group saw an improvement in 3 or more glands secreting clear, grade 3 meibum at both day 43 and 85. Symptoms like fluctuating vision, itching, burning, and redness were better in the lotilaner group as well.

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Product news

• The FDA has approved an NDA labeling supplement to iDose TR (travoprost intracameral implant, Glaukos) that allows re-administration using a repeat treatment protocol. According to the company’s press release, re-administration of iDose TR is permitted in patients who maintain healthy corneal endothelial cell density.

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