California Declaration of Compliance

Last Updated: November 12, 2024

RxSight, Inc. (RxSight) is a medical device manufacturer that is committed to conducting its business with integrity and in compliance with all applicable laws. RxSight has established a Comprehensive Compliance Program (CCP) that is reasonably designed with consideration given to the goals of California Health and Safety Code §§ 119400 – 119402, the current operations, size, and organization of our company, and the general principles the Code of Ethics on Interactions with U.S. Health Care Professionals, a voluntary ethical code published by the Advanced Medical Technology Association (AdvaMed).

To the best of our knowledge and based on a good faith understanding of the statutory requirements in the State of California, as of the date noted below, RxSight declares that it has established a Comprehensive Compliance Program (CCP) that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. RxSight declares that, based upon its current internal tracking and monitoring systems, it is in compliance in all material respects with the provisions of its CCP.

To obtain a copy of this Declaration or an the CCP, please contact us at: compliance@rxsight.com or at 833-888-7974.

©2024 RxSIGHT. All Rights Reserved. COM-1043 Rev. J

LAL patients saw nearly as well without glasses (UCDVA) as control patients did with glasses (BCDVA).

The LAL provides optimized vision for patient satisfaction.2

LAL patients saw nearly as well without glasses (UCDVA) as control patients did with glasses (BCDVA).

Since the LAL is a monofocal lens, there is low risk of dysphotopsias caused by splitting light, leading to potentially enhanced vision and patient satisfaction.

LAL patients are approximately two times more likely to achieve 20/20 vision or better without glasses at 6 months.

The LAL offers LASIK-like accuracy in cataract surgery.2,3

92% of eyes (N = 391) achieved results within 0.50 D of target manifest refraction spherical equivalent (MRSE).

Patients are approximately two times more likely to achieve 20/20 vision or better without glasses at 6 months.

The study was a prospective, controlled, multicenter, 12-month study of 600 patients (ITT population) randomized to receive implantation with the RxSight LAL (N = 403) or a commercially available monofocal IOL (N = 197). Effectiveness analyses included 391 LAL patients and 193 control patients. Primary safety variables included best spectacle-corrected visual acuity (BSCVA) at 6 months and incidence of sight-threatening complications and adverse events. Primary effectiveness variables included percent reduction in manifest cylinder at 6 months, percent mean absolute reduction in MRSE at 6 months, and rotation of meridian of LAL at 6 months. Percent of eyes with an uncorrected visual acuity (UCVA) of 20/20 or better at six months post-operatively compared between the LAL treatment group and the monofocal control group was a secondary endpoint.

The Light Adjustable Lens corrects as low as 0.50 D of astigmatism, which is the lowest level approved to be treated.

The ability to treat 0.50 D of postoperative cylinder makes the Light Adjustable Lens the only IOL in the United States approved to correct this level of vision-altering astigmatism. Astigmatism of as little as 0.50 D can reduce visual acuity by one line, and the impact on dynamic, functional visual acuity and low-contrast acuity is even greater.1