I. Regulatory Status
LumenPro Veterinary StrengthTM is a lubricating ophthalmic agent for use with animals. LumenPro Veterinary StrengthTM conforms with the over-the-counter (OTC) drug monograph for ophthalmic products established by the Food and Drug Administration (FDA) at 21 C.F.R. Part 349. Products conforming with an FDA monograph are generally recognized as safe and effective, and do not require Pre-Market Approval by the FDA. As such, the claims made by LumenPro Veterinary StrengthTM have not been evaluated by the FDA. Rather, all claims with regards to supporting health vision are qualified health claims, backed by peer-reviewed studies. LumenPro Veterinary StrengthTM should not be used as a substitute for any medications.
Lanosterol (complexed) 0.375%
Kolliphor P 188
III. Recommended Dosage
LumenPro Veterinary StrengthTM is safe and effective to administer to dogs, cats, rabbits, horses and rodents. The recommended dosage is to apply one drop to each affected eye, twice daily.
IV. Adverse Reactions
If your pet’s eyes are red or irritated after using LumenPro Veterinary StrengthTM, discontinue use and apply a lubricating or rinsing solution (e.g. saline). Contact your veterinarian if these symptoms persist beyond 24 hours.
Reduced Tear Production
LumenPro Veterinary StrengthTM is not recommended for pets with poor tear production, and its use may result in redness or irritation. Veterinarians should consider performing a tear test prior to recommending LumenPro
Animals with diabetes commonly develop cataracts, and can benefit from LumenPro Veterinary StrengthTM. For the best outcome, veterinarians should ensure the underlying diabetes is treated and under control before recommending
LumenPro Veterinary StrengthTM.
LumenPro Veterinary StrengthTM is believed to have negligible systemic uptake, and there are no known interactions with medications.
VII. Manufacturer Information
LumenPro Veterinary StrengthTM is manufactured by Heliostatix, 115 Sully’s Trail, Suite 14, Pittsford, New York 14534.
VIII. Product Information
- Volume: 15 mL
- Weight (Including Packaging): 0.09 lb
- Weight (Bottle Only): 0.06 lb
- Box Dimensions (H x W x L): 3.6”x 1.1”x 1.1”
- Bottle Dimensions (H ; D): 3” ; 0.9”
- Stability: 18 months
IX. Qualified Health Claims Regarding Lanosterol
Lanosterol (from lanolin) is an ingredient approved by the FDA for use in lubricating eye drops. Laboratory studies have also shown the role lanosterol plays in slowing, halting and reversing the progression of cataracts in dogs and rabbits. Claims based on these studies have not been evaluated by the U.S. Food and Drug Administration.
LumenPro Veterinary StrengthTM uses a patent pending delivery system to make lanosterol bioavailable via ophthalmic solution. While research has focused on the efficacy of this system in canine and leporine subjects, the same mechanism is viable in any species in which the Lanosterol Synthase Pathway is present.
(1) Zhao L, Chen XJ, Zhu J, Xi YB, Yang X, Hu LD, et al. Lanosterol reverses protein aggregation in cataracts. Nature. 2015;523:607–11.
(2) Babizhayev, Mark A., et al. “Efficacy of N-Acetylcarnosine in the Treatment of Cataracts.” Drugs in R & D, vol. 3, no. 2, 2002, pp. 87–103.
(3) Shanmugam PM, Barigali A, Kadaskar J, et al. Effect of lanosterol on human cataract nucleus. Indian J Ophthalmol. 2015;63(12):888–890. doi:10.4103/0301-4738.176040