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Dr. Rachelle Lin highlights the urgent need for early intervention in childhood myopia, discusses associated retinal and systemic risks, and emphasizes the long-term impact of axial length control in reducing serious ocular complications.

CRU 2025: Managing myopia today to prevent vision loss tomorrow

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The expansion will allow the company to double the number of intraocular lenses manufactured every year to 4 million.

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The author is a correspondent for <I>Urology Times</I>, a sister publication.

Lamina cribrosa deformation a potential prognostic factor in glaucoma

Clinical stage biotech company Tenpoint Therapeutics announced positive topline results from BRIO-II, a Phase 3 pivotal trial assessing BRIMOCHOL PF for the treatment of presbyopia. According to a company news release, the clinical trial successfully met pre-specified visual acuity primary endpoints in both the US and European Union (EU)/United Kingdom (UK) with statistically significant near vision improvements recorded at all time points over 8 hours (p<0.008). Those primary endpoints were agreed upon with the US FDA, European Medicines Agency, and the UK Medicines and Healthcare Products Regulatory Agency.

The 3-arm, multicenter, randomized, double masked, safety and efficacy study (NCT05135286) evaluated BRIMOCHOL PF, a carbachol/brimonidine tartrate fixed-dose combination topical ophthalmic solution, in comparison to a carbachol monotherapy topical ophthalmic solution and a vehicle topical ophthalmic solution in the 629 participants with emmetropic phakic or pseudophakic presbyopia. Participants were enrolled in 47 different sites in the US.

“Tenpoint Therapeutics is the only company in the presbyopia category to demonstrate contribution of elements with BRIMOCHOL PF, paving the way for a combination drug approval that offers the additional benefits of brimonidine,” said Rhett Schiffman, MD, MS, MHSA, chief medical officer and head of Research and Development at Tenpoint, in the release. “In our studies, brimonidine increased the magnitude and duration of action of carbachol and reduced the incidence of hyperemia (eye redness) over carbachol alone. BRIMOCHOL PF is the only presbyopia correcting eye drop to have gone through a 12 month safety study. It was very well tolerated over 12 months of continuous dosing and subjects in the study reported very high compliance during the study and a strong willingness to use the drug. We are very grateful to the investigators, their staff, and the study participants for their enormous efforts in this groundbreaking trial.”

Tenpoint cited that brimonidine also significantly improved reading speed and patient reported quality of life outcomes based on the NEI-Refractive Error Quality of Life questionnaire, in addition to no treatment related serious adverse events reported. Additionally, BRIMOCHOL PF demonstrated clinically and statistically significant reductions in pupil size at all timepoints. This reduction in pupil size was cited as a key mechanism of action for the miotic class of therapies creating a pinhole effect that correct for the loss of near vision and increases depth of focus.

While BRIMOCHOL PF accomplished correction of lost near vision and a depth of focus increase, distance vision improvements and gradual resolution of miosis over 10 hours was also recorded in the clinical trial. According to Tenpoint, less miosis later in the day may minimize difficulties concerning nighttime vision. Additionally, no tachyphylaxis was observed in either vision or pupil effects over the duration of the 12 month at-home dosing phase of the study.

“I am very pleased to see that BRIMOCHOL PF was not only well tolerated over a 12 month dosing study, but also achieved a functional improvement in reading speed, something that patients really care about,” said John Hovanesian MD, a member of Tenpoint’s Medical Advisory Board, in the release. “BRIMOCHOL PF has demonstrated a profile that, if approved, will meet the needs for a large proportion of presbyopes and I’m excited for the product to become a reality for patients.”

Further details from the study will be presented at upcoming scientific meetings, according to Tenpoint.

Tenpoint Therapeutics announces positive topline data from Phase 3 pivotal study, BIO-II, of BRIMOCHOL PF for the treatment of presbyopia. News release. Tenpoint Therapeutics. January 8, 2025. Accessed January 9, 2025.

The 3-arm, multicenter, randomized, double masked, safety and efficacy study successfully met pre-specified visual acuity primary endpoints with statistically significant near vision improvements recorded at all time points over 8 hours.

Tenpoint Therapeutics announces positive topline results from Phase 3 pivotal trial BRIO-II assessing BRIMOCHOL PF for the treatment of presbyopia

 is a common ocular condition marked by a loss of homeostasis anywhere in the cycle, causing or worsening tear film instability, hyperosmolarity, and inflammation of the ocular surface.

 This condition significantly impairs visual quality, leading to challenges in daily activities such as driving, reading, and computer use.

 Addressing DED is crucial for improving patient satisfaction and quality of life and maintaining practice efficiency.

Supportive care often falls short for patients with DED

Patients with DED frequently report symptoms including burning, stinging, grittiness, foreign body sensation, light sensitivity, ocular pain, and blurred vision.

 These symptoms negatively impact quality of life and may also reduce visual function and productivity.

 If left untreated, DED may lead to recurring patient complaints,

 persistent discomfort, and long-term ocular damage.

 Early diagnosis and intervention are essential to prevent these adverse outcomes and improve the patient’s visual function and overall well-being.

DED can be identified through comprehensive evaluations, including clinical assessments like corneal staining

Management strategies often include artificial tear supplements, prescription therapies targeting various causative factors, and lifestyle modifications.

Proactive management can alleviate symptoms, enhance visual function, and reduce risk of increased follow-ups.

DED is commonly categorized as aqueous deficient, evaporative, or mixed. Excessive tear evaporation due to meibomian gland dysfunction is the leading cause, affecting approximately 90% of patients with DED.

Prescription treatments target the insufficient tear production, inflammatory pathways, or excessive evaporation that perpetuate DED. Cyclosporine-based therapies (Restasis, AbbVie; Cequa, Sun Ophthalmics; Vevye, Harrow) act by inhibiting T-cell activation through the calcineurin-phosphate pathway, resulting in increased tear production and protection of conjunctival goblet cells.

 Cequa employs nanomicellar technology to enhance cyclosporine delivery

 whereas Vevye uses a semifluorinated alkane (SFA), perfluorobutylpentane (PFBP or F4H5), as a vehicle.

Lifitegrast ophthalmic solution 5% (Xiidra; Bausch+Lomb) addresses ocular inflammation through mechanisms such as inhibiting T-cell activation, blocking T-cell recruitment to the ocular surface, and reducing inflammatory cytokine secretion.

Lifitegrast binds to lymphocyte function-associated antigen-1, a protein found on the surface of leukocytes, preventing its interaction with its ligand intercellular adhesion molecule-1.

Perfluorohexyloctane ophthalmic solution (Miebo; Bausch+Lomb) targets the evaporative aspect of DED.

 Composed entirely of perfluorohexyloctane (PFHO or F6H8), Miebo reduces tear evaporation by forming a stable monolayer on the tear film and has a prolonged ocular surface residence time due to its low volatility.

 In doing so, PFHO compensates for deficiencies in meibum and stabilizes the lipid layer of the tear film, which results in improved tear film homeostasis.

 Although both Miebo and Vevye contain an SFA (chemically inert molecules consisting of a fluorocarbon segment and a hydrocarbon segment),

 their physiochemical properties lead to distinct functionalities. The SFA in Vevye’s formulation (PFBP) serves as a vehicle to solubilize cyclosporine better than PFHO yet does not inhibit evaporation.

 In contrast, Miebo (PFHO) exhibits antievaporative effects due to its unique chemical structure.

 The longer chain length of PFHO enables the formation of a stable monolayer at air-liquid interfaces.

 Additionally, PFHO’s higher boiling point

(indicating lower volatility) ensures slower evaporation and prolonged ocular surface residence time.

 Unlike PFBP, PFHO was shown to stabilize the tear film lipid layer in a 7-day study in rabbits.

Varenicline nasal spray (Tyrvaya; Viatris) stimulates tear production via the trigeminal parasympathetic pathway.

 Varenicline, a nicotinic acetylcholine receptor agonist, activates this pathway when administered intranasally.

Symptom reduction as a key differentiator among treatments

Clinical trials evaluating cyclosporine-based treatments for DED include randomized, vehicle-controlled studies of Restasis,

 Across these studies, cyclosporine-based eye drops showed significantly greater improvements in DED signs (eg, corneal staining, Schirmer test) compared with vehicle controls.

 However, reductions in DED symptoms were generally similar between the active treatment and control groups.

 For Restasis, no significant differences were observed between the treatment and control groups for symptoms such as eye dryness, sandy/gritty sensation, burning, stinging, itching, and pain, although a notable improvement in blurred vision was observed.

 For Cequa, changes in the global symptom score were comparable to the vehicle.

 For Vevye, the primary symptom end points (Ocular Surface Disease Index score in ESSENCE-1 and eye dryness in ESSENCE-2) were not met, although secondary analyses showed a significantly greater reduction in eye dryness for Vevye compared with vehicle in ESSENCE-1.

Lifitegrast was assessed in 4 randomized, placebo-controlled trials (phase 2, OPUS-1, OPUS-2, OPUS-3).

 Pooled results from these trials demonstrated that lifitegrast effectively addressed both prespecified end points: signs (corneal staining) and symptoms (eye dryness and discomfort) of DED, with improvements in eye dryness as early as 2 weeks after treatment initiation.

PFHO was found to deliver rapid and sustained improvements in both signs (corneal staining) and symptoms (eye dryness, burning/stinging) of DED, with consistently greater effects than a hypotonic saline (0.6%) control in 2 randomized controlled trials (GOBI, MOJAVE).

Both signs and symptoms were improved by the earliest assessment time point of day 14. A postmarketing study recently demonstrated relief of patients’ symptoms as early as day 3 of treatment.

In randomized, vehicle-controlled studies (ONSET-1, ONSET-2), varenicline nasal spray outperformed the vehicle in improving Schirmer test scores, consistent with its mechanism of action), and significantly reduced eye dryness at most assessments in ONSET-1.

Identifying and appropriately treating DED is vital to ensure patient comfort and visual quality and function. Treatment decisions should consider disease etiology, symptom burden, and patient preferences. For aqueous-deficient DED, cyclosporine-based products or varenicline nasal spray may be appropriate, with patient choice guiding between a drop or nasal spray. PFHO is particularly effective for evaporative DED, whereas lifitegrast may be favored in cases involving inflammation. Products that alleviate symptoms, such as lifitegrast and PFHO, may be preferable for patients most troubled by discomfort. A personalized approach to therapy selection can optimize outcomes for individuals with DED.

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An overview of prescription medications available for DED.

Fred Gebhart

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