SEPETAPROST

Sepetaprost, developed by Santen and Ono Pharmaceuticals, is sold as Setaneo ophthalmic solution 0.002% as a once-daily eyedrop to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). 

Sepetaprost is a novel investigative prodrug. It is a bicyclic prostaglandin derivative. The active form binds to and stimulates FP and EP3 receptors, promoting aqueous humor outflow and thereby lowering intraocular pressure (IOP). By activating both receptors, it increases the outflow of aqueous humor from the eye more effectively than traditional first-line prostaglandin analogs.

Clinical studies have shown that Sepetaprost 0.002% provides sustained IOP reduction consistently over 24-hours.

Comparisons with Timolol and Latanoprost have shown noninferior or superior efficacy of Sepetaprost. [1,2]

Conjunctival hyperemia (redness of the eye) is the most frequently reported ocular side effect. The majority of reported adverse reactions were considered mild to moderate, with no unexpected systemic safety concerns observed.

CLINICAL STUDIES 

1. The ANGEL-2 Study:

Involved 323 adult (≥18 years) participants (POAG, 68.4%; OHT, 31.6%) who were randomized 1:1 to receive either once-daily sepetaprost (n = 162) or twice-daily timolol (n = 161) in 1 eye for 3 months.

Results:

The primary endpoint, the noninferiority of sepetaprost to timolol in mean IOP reductions, was met. The upper limit of the 2-sided 95% CI for the between-group difference in mean IOP score was <1.0 mmHg at all 9 timepoints. Superiority of sepetaprost to timolol was observed at 4:00 pm in week 2, week 6, and month 3; IOP mean difference (standard error): −0.76 (0.302), –0.73 (0.328), and −0.95 (0.319), respectively (all P < 0.05). Overall, 23.6% of participants receiving sepetaprost and 21.3% receiving timolol experienced AEs. The most commonly reported ocular AE in both groups was conjunctival hyperemia (sepetaprost, 9.9%; timolol, 2.5%).

Conclusions:

Once-daily sepetaprost 0.002% was statistically noninferior to twice-daily timolol 0.5% for lowering IOP in participants with POAG or OHT. There were no unexpected safety concerns observed, and all AEs were mild or moderate in severity.

REFERENCE:

Wirta DL, El-Harazi SM, Tepedino ME, Bacharach J. Sepetaprost 0.002% Noninferiority vs. Timolol 0.5% in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: ANGEL-2. Ophthalmol Glaucoma. 2025 Jul-Aug;8(4):384-392. doi: 10.1016/j.ogla.2025.02.004. Epub 2025 Mar 4. PMID: 40043909.

2. In another study, 33 participants received treatment (sepetaprost, n = 17; latanoprost, n = 16). Mean 24-h IOP was numerically lower with sepetaprost vs. latanoprost at month 3 (- 0.88 mmHg; 95% confidence interval [CI] - 2.89, 1.14; not statistically significant at the 0.05 level [NS]). Mean change from baseline in IOP at month 3 ranged from - 5.63 to - 7.00 mmHg for sepetaprost and - 3.84 to - 6.66 mmHg for latanoprost. Lower nocturnal IOP was observed with sepetaprost vs. latanoprost at month 3 (- 1.61 mmHg difference; 95% CI - 4.05, 0.83; not statistically significant; however, the 90% CI was - 5.27, - 0.17 and therefore, nominal statistical significance was achieved at the 0.10 level). Mean difference between groups indicated similar, or numerically lower, IOP with sepetaprost at individual time points at week 6 and month 3. At 36 and 48 h following sepetaprost cessation, mean IOP was lower vs. baseline IOP at the same time points. AEs occurred in 13 (76.5%) vs. 11 (68.8%) participants treated with sepetaprost vs. latanoprost.

Conclusions: 

In participants with POAG or OHT, mean 24-h IOP and nocturnal IOP at month 3 were consistently numerically lower with sepetaprost vs. latanoprost. Safety profiles were similar between groups.

REFERENCE:

Konstas AG, Garhöfer G, Lübke J, Voykov B, Ropo A. A Study of 24-h Efficacy and Safety of Sepetaprost vs. Latanoprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension. Adv Ther. 2025 Aug;42(8):3810-3825. doi: 10.1007/s12325-025-03227-2. Epub 2025 Jun 10. PMID: 40493333; PMCID: PMC12313740.

CALIBREYE TGT SURGICAL SYSTEM

 

The Calibreye TGT Surgical System is intended to offer an adjustable solution to control IOP in patients with glaucoma.

The Calibreye is being evaluated as an Investigative Device Exemption (IDE) device, under the ADAPT trial. The first patient for the trial was recently enrolled by Myra Vision, the company involved in the manufacture of the device.

The ADAPT trial is a prospective, multicenter, nonrandomized open-label study that will enroll up to 70 refractory glaucoma patients with a 12-month primary effectiveness endpoint. The clinical investigation will evaluate the safety and effectiveness of the company’s titratable glaucoma therapy system, designed to optimize IOP reduction in patients undergoing glaucoma surgery. Once implanted, the Calibreye aqueous shunt is designed to enable slit lamp-based outflow adjustments as individual patient requirements evolve over time.

The Calibreye has the following specifications:

10.0 x 1.6–mm overall dimensions intended to provide posterior bleb formation to increase aqueous drainage.

Low profile (0.30 mm thick) to help maximize patient comfort and minimize erosion risk.

Suture eyelets for a secure shunt placement.

Visual indication for confirmation of channel settings.

Uses materials with well-known ophthalmic biocompatibility:

Silicone

• Hydrophobic properties help reduce protein binding to minimize cellular adhesion.
• Flexible and stable polymer with minimal biodegradation in vivo.
• Hyperemia is milder than with stainless steel
• Inflammatory response is milder than with polypropylene used in other devices.

Valve components composed of nitinol, a material with a proven history of use in ocular applications.

A multi-center international feasibility study involving Calibreye implantation, enrolled 43 patients with moderate to late-stage disease, of which 33 patients had greater than 3 months of follow-up, at four sites in three countries. 

The 3-month clinical trial results presented demonstrated:

1. 44.9% intraocular pressure (IOP) reduction compared to baseline, with an average IOP of 12.1 mmHg.
2. 88% of patients were medication-free, with 100% of patients on less than or equal to the number of meds at baseline.
3. Over 96% mean medication reduction compared to baseline, equating to a mean reduction of over 3 medications per patient.
4. No patients required bleb needling procedures.
5. 100% of devices implanted successfully, 100% of titrations completed successfully with an average of 2.2 titrations per patient.

GamifEye VISUAL FIELD ANALYZER

GamifEye is a unique virtual reality (VR) visual field (VF) testing technology. It has been developed by Envision Health Technologies and integrated with systems like ZEISS perimetry. The headset-based system replaces traditional, bulky machines to measure peripheral and central vision.

Additionally, the adaptive perimetry software provides optimal patient comfort and portability.

The technology is based on a clinically-validated gamified testing strategy that transforms VF tests into interactive games with an immersive and intuitive experience.

The software provides automated adaptive perimetry (AAP) with novel algorithms that both personalize testing and adapt as defects are discovered (intended to reduce testing/retesting variability).

The intuitive VF testing system offers earlier detection of glaucoma-related vision loss as an alternative to the current standard of care i.e. static automated perimetry table-mounted devices.

The technology offers comprehensive VF assessments such as:

• 10-2, 24-2, 24-2C, and 30-2 VF testing
• Esterman binocular VF testing
• Ptosis and function field assessment

Envision's Advanced Progression Analytics module is designed to deliver deeper, more clinically meaningful insight into disease progression by integrating both global and localized functional change into a unified analytical framework.

Incorporating VR headsets in VF testing presents several advantages over gold standard perimetry methods, which primarily rely on conventional devices such as the Humphrey Visual Field Analyzer and the Octopus Perimeter. 

One significant advantage of VR headset-based perimetry is the immersive and controlled testing environment it offers, which can help minimize distractions and external light interference that may affect test results.

Further, the portability and affordability of VR headsets allow for more flexible testing locations, reduce testing times, and potentially pave the way for telemedicine applications, making visual field testing more accessible to patients in remote or underserved areas.

Additionally, VR headsets offer numerous advantages over traditional devices, such as the ability to present stimuli in a fully immersive, three-dimensional environment, which may enhance the ecological validity of the testing and patients’ engagement in their healthcare. 

Finally, VR headset-based perimetry headsets can be easily customized to suit individual patient needs and may offer more engaging and interactive testing experiences, potentially reducing patient fatigue and improving test reliability.