Lunara Overnight Orthokeratology Lens Available for Temporary Myopia Reduction
Headline
FDA-Approved Lunara Overnight Orthokeratology Lens Becomes Available for Temporary Myopia Reduction of Up to 6 D
1-minute summary
The Lunara overnight orthokeratology lens has become commercially available for the temporary reduction of myopia, according to a press release from X-Cel Specialty Contacts and Essilor Custom Contacts.
The lens has received FDA premarket approval (PMA) for temporary reduction of myopia of up to 6.00 diopters (D) in eyes with up to 1.75 D of astigmatism.
The lens uses Optimum Infinite (tisilfocon A) material manufactured by Contamac and has an oxygen permeability of 180 Dk.
The available fitting parameters include a 6.5- to 10.5-mm base curve, 9.5- to 12-mm overall diameter, and 5- to 7-mm optic zone.
The supplied report emphasizes that orthokeratology has sometimes been used off-label to attempt to slow myopia progression, but the FDA approval described here is specifically for temporary myopia reduction, not for prevention or slowing of myopia progression.
The manufacturer also reports that fitting is familiar to practitioners experienced with orthokeratology and that fitting support is available for practices transitioning from other tangential-fitting lens systems.
Why this matters
Orthokeratology uses specially designed rigid contact lenses worn overnight to temporarily reshape the cornea. This can reduce refractive myopia during the subsequent waking period.
The regulatory distinction is important:
FDA-approved indication described in the source:
Temporary reduction of myopia.
Not described as an FDA-approved indication:
Slowing or preventing myopia progression.
The source specifically notes that orthokeratology lenses may be used off label for myopia-progression control, but the lens discussed here is approved for temporary myopia reduction.
Study at a glance
This report does not describe a randomized clinical trial, cohort study, meta-analysis or other comparative clinical investigation. It is a product availability announcement based primarily on a company press release.
| Feature | Details |
|---|---|
| Report type | Product/regulatory announcement |
| Product | Lunara overnight orthokeratology lens |
| Regulatory status | FDA PMA approved |
| Indication | Temporary reduction of myopia |
| Maximum myopia reported | Up to 6.00 D |
| Maximum astigmatism reported | Up to 1.75 D |
| Lens material | Optimum Infinite (tisilfocon A) |
| Material manufacturer | Contamac |
| Oxygen permeability | 180 Dk |
| Base curve | 6.5-10.5 mm |
| Overall diameter | 9.5-12 mm |
| Optic zone | 5-7 mm |
| Comparator | Not applicable |
| Clinical primary outcome | Not reported in the supplied article |
| Clinical follow-up | Not reported |
| Source | Company press release |
| FDA PMA date cited | February 10, 2026 |
Product indication
According to the supplied report, Lunara is indicated for the temporary reduction of myopia up to 6 D in eyes with astigmatism of up to 1.75 D.
Reported refractive indication
| Parameter | Reported range/limit |
|---|---|
| Myopia | Up to โ6.00 D |
| Astigmatism | Up to 1.75 D |
The word โtemporaryโ is clinically important because the corneal reshaping effect of orthokeratology is reversible and depends on continued lens use.
Lens material and oxygen permeability
Lunara is manufactured using Optimum Infinite, a material identified in the source as tisilfocon A from Contamac.
The reported oxygen permeability is:
180 Dk
Oxygen permeability is an important consideration for overnight contact-lens wear because the cornea receives less atmospheric oxygen when covered by a lens.
However, the supplied article does not provide comparative clinical data demonstrating that the reported Dk value results in a particular rate of adverse events or superior safety compared with other orthokeratology materials.
Available fitting parameters
The company reported the following parameters:
| Parameter | Available range |
|---|---|
| Base curve | 6.5-10.5 mm |
| Overall diameter | 9.5-12 mm |
| Optic zone | 5-7 mm |
These parameters provide practitioners with a range of lens configurations for fitting patients.
The source does not provide outcome data showing which specific parameter combinations are associated with superior refractive results.
FDA regulatory status
The source states that Optimum Infinite orthokeratology lenses received FDA premarket approval on February 10, 2026.
The approval described in the article concerns the use of the lens for temporary myopia reduction.
It is important not to interpret this approval as an FDA indication for myopia-control therapy unless such an indication is separately specified in the relevant regulatory labeling.
Orthokeratology and myopia progression
The source makes an important distinction between two potential uses of orthokeratology.
Temporary refractive correction
The FDA-approved indication described in the article is temporary reduction of myopia.
Myopia-progression control
Orthokeratology lenses have also been used off label to attempt to slow myopia progression.
The article explicitly states that the lenses discussed are not formally approved for that indication.
Therefore, clinicians should distinguish between:
| Purpose | Status described in source |
|---|---|
| Temporary reduction of myopia | FDA-approved indication described |
| Slowing myopia progression | Off-label use |
| Prevention of myopia onset | Not established by this report |
Fitting process
Kim Peters, marketing manager at X-Cel Specialty Contacts/Essilor Custom Contact Lens Specialists, described the fitting process as:
โfamiliar to anyone who has been fitting orthokeratology lenses in the past 20 yearsโ
According to the company, fitting support is available by telephone.
The company also reports that it provides:
โdedicated support for practices transitioning from other tangential-fitting lens systemsโ
This suggests that the manufacturer is positioning the product for both practitioners already experienced with orthokeratology and practices transitioning from other specialty lens systems.
Company-described product features
Derrell James, vice president and general manager at X-Cel Specialty Contacts/Essilor Custom Contact Lens Specialists, described Lunara as combining:
โpremium material performance, flexible parameters, fast turnaround and direct access to knowledgeable specialty contact lens consultantsโ
He further stated:
โLunara reflects how we believe specialty contact lens manufacturers should support practices: with a strong product backed by equally strong operational support.โ
These statements are company claims and should be distinguished from independently generated clinical evidence.
What the report establishes
Based on the supplied article, the following information is reported:
- Lunara is now commercially available.
- It is an overnight orthokeratology lens.
- FDA PMA approval was reported on February 10, 2026.
- The described indication is temporary reduction of myopia.
- The reported myopia range extends to 6 D.
- The reported astigmatism limit is 1.75 D.
- The lens uses tisilfocon A material.
- Oxygen permeability is reported as 180 Dk.
- Specific fitting parameter ranges are available.
- Manufacturer-supported fitting assistance is available.
What the report does not establish
The supplied article does not provide:
- a randomized comparison with another orthokeratology lens;
- a prospective comparative clinical trial;
- a quantified change in refractive error over a defined follow-up period;
- axial-length outcomes;
- long-term myopia-progression outcomes;
- comparative infection rates;
- comparative corneal adverse-event rates;
- patient-reported outcomes;
- retention or discontinuation rates; or
- independent peer-reviewed clinical efficacy data.
Consequently, those outcomes should not be inferred from the regulatory/product announcement.
Clinical significance
For optometrists and ophthalmologists who provide specialty contact-lens care, the availability of another FDA-approved overnight orthokeratology option may expand the range of products available for patients requiring temporary myopia reduction.
The reported parameter range may also provide flexibility when fitting patients with different corneal geometries.
However, the clinical significance of the productโs material characteristics and parameter flexibility cannot be quantified from the supplied report alone because comparative clinical outcomes were not provided.
Limitations
1. Source is a press release
The primary source identified in the article is a press release, rather than an independent peer-reviewed clinical study.
2. No comparative efficacy data
The report does not compare Lunara with another orthokeratology lens or conventional refractive correction.
3. No detailed safety dataset
The article does not provide rates of microbial keratitis, corneal staining, hypoxia-related complications or other adverse events.
4. No long-term progression data
The report does not establish whether the product slows axial elongation or long-term myopia progression.
5. Manufacturer involvement
The information regarding fitting support, turnaround and product performance comes from the manufacturer or company representatives and should therefore be interpreted in that context.
What doctors should know
- Lunara is an overnight orthokeratology lens intended for temporary myopia reduction.
- The reported FDA-approved range extends to 6 D of myopia.
- The reported astigmatism limit is 1.75 D.
- The lens uses tisilfocon A (Optimum Infinite) material.
- Reported oxygen permeability is 180 Dk.
- Base curves range from 6.5 to 10.5 mm.
- Overall diameters range from 9.5 to 12 mm.
- Optic zones range from 5 to 7 mm.
- The source distinguishes temporary myopia reduction from myopia-progression control.
- Orthokeratology may be used off label for myopia control, but the approval described in this report is for temporary myopia reduction.
- The supplied report does not provide sufficient evidence to determine whether Lunara is superior to other orthokeratology systems.
- Standard patient selection, fitting, follow-up and overnight contact-lens safety considerations remain important.
Bottom line
Lunara is now available as an FDA PMA-approved overnight orthokeratology lens for temporary reduction of myopia of up to 6 D in eyes with up to 1.75 D of astigmatism.
The lens uses tisilfocon A material with a reported oxygen permeability of 180 Dk and offers multiple fitting parameters.
The announcement is primarily regulatory and product-focused rather than clinical-outcomes research. It therefore establishes the productโs reported indication and specifications but does not, by itself, establish comparative efficacy, long-term safety, or effectiveness for slowing myopia progression.
Original research / DOI
Not applicable.
The supplied article identifies its source as a press release.
Product: Lunara overnight orthokeratology lens
Manufacturer/distributors identified: X-Cel Specialty Contacts / Essilor
Material: Optimum Infinite (tisilfocon A), Contamac
