PainReform Commences Development for OcuRing™-K Phase II Trial, LayerBio’s Drop-Less Sustained-Release Ocular Therapy
Rhea-AI Summary
PainReform (Nasdaq: PRFX) commenced development of OcuRing-K, LayerBio’s intraoperatively administered, erodible sustained‑release ocular device, and is advancing toward a Phase II clinical trial for post‑cataract pain and inflammation.
OcuRing‑K delivers controlled ketorolac release to target tissues, aims to replace multi‑week eye‑drop regimens, and showed pain and inflammation reductions in preclinical studies and a Phase I evaluation with lower total drug exposure. The program targets the large cataract surgery market (~4.5M US surgeries; ~$9B global annual procedure volume) and may expand to additional ophthalmic indications pending further clinical progress and regulatory approval.
Positive
- Advanced to Phase II clinical development
- Phase I and preclinical data showed reduced pain and inflammation
- Targets large market: 4.5M US cataract surgeries and $9B global volume
- Platform supports multiple ophthalmic therapeutics beyond NSAIDs
Negative
- OcuRing‑K is not approved and requires successful Phase II/III and regulatory clearance to access the reimbursable US market
- Commercial opportunity depends on future clinical and regulatory outcomes, not yet demonstrated
Insights
PainReform advancing OcuRing™-K into Phase II after Phase I and preclinical signals of reduced pain and inflammation with lower drug exposure.
The program uses an erodible intraoperative sustained-release device to deliver ketorolac directly to ocular tissues, replacing multi-week drop regimens and aiming to maintain steadier local drug levels while lowering systemic exposure. The release mechanism and single-dose, in-situ depot approach explain how the product could simplify postoperative care and reduce contamination risks tied to patient-applied drops.
Key dependencies include successful Phase II safety and efficacy readouts and U.S. regulatory acceptance to access the reimbursable cataract surgery market. The announcement cites preclinical studies and a Phase I clinical evaluation showing reductions in post-surgical pain and inflammation and sustained therapeutic kinetics; those results are the factual basis for progression but require confirmation in a well-powered Phase II. Watch for trial design details, primary endpoints, enrollment timeline, and regulatory interactions over the next 12–24 months; a clear U.S. pathway would materially affect commercial prospects given roughly
Development plan positions OcuRing™-K for advancement in the fast-growing, multi-billion-dollar global cataract surgery market
TEL AVIV, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) today announced, through its pharmaceutical division, the commencement of its development plan for OcuRing™-K, LayerBio’s patented, drop-less, intraoperatively administered sustained-release ocular therapy designed to deliver controlled, site-specific release of ketorolac following cataract surgery. Following the closing of PainReform’s majority investment in LayerBio and the integration of OcuRing-K into PainReform’s development portfolio, the Company conducted a methodical internal assessment with LayerBio’s management team to define development priorities and establish a clear path for advancing the program. Work is now progressing toward the Phase II clinical trial.
OcuRing-K is an erodible, intraoperatively administered sustained-release device designed to provide extended and consistent intraocular therapeutic levels of an NSAID (non-steroidal, non-opiate, anti-inflammatory analgesic). LayerBio’s technology is designed to address major limitations of traditional postoperative eye-drop regimens, which typically require multiple daily steroid and NSAID drops for several weeks and deliver only a small fraction—often less than
This inefficient delivery of eye drops produces sharp fluctuations in drug levels, increasing the potential for inconsistent efficacy and side effects. In contrast, OcuRing-K’s in-situ depot formulation provides direct, localized delivery to target tissues with markedly lower systemic exposure, offering controlled and stable therapeutic coverage compared to conventional eye drops. By removing the need for patient-administered drops, OcuRing-K also reduces contamination risks, such as inadvertent contact between dropper bottles and ocular tissues.
Preclinical studies and a Phase I clinical evaluation demonstrated reductions in post-surgical pain and inflammation while using significantly lower total drug exposure than standard eye-drop regimens. The sustained-release kinetics of OcuRing-K maintained therapeutic levels over time, supporting the potential for improved ocular safety, reduced systemic side effects associated with high-volume topical dosing, and enhanced patient compliance, particularly among elderly populations.
Cataract surgery is one of the most common procedures worldwide, with approximately 4.5 million surgeries performed annually in the United States and more than
LayerBio’s sustained-release platform also supports delivery of a wide range of other ocular therapeutics—including NSAIDs, antibiotics, steroids, and anti-VEGF agents—aligning with PainReform’s plans to explore additional ophthalmic indications following the development of OcuRing-K.
“Our plan identifies post-cataract pain and inflammation as the initial target indication for OcuRing-K. Commencing the development plan for OcuRing-K and advancing work toward the next clinical trial marks a key milestone in our strategy to deliver meaningful, drop-less solutions to one of the most common and impactful surgical procedures worldwide,” said Ehud Geller, Chairman of PainReform. “LayerBio’s data demonstrate the potential of this sustained-release depot technology to provide consistent pain and inflammation control with significantly lower drug exposure than traditional drops. With this plan in place, PainReform is well positioned to advance OcuRing-K into its next phase of development.”
As previously announced, PainReform and LayerBio plan to advance OcuRing-K through its next stage of clinical development in the United States, where approval could unlock a high-volume reimbursable market and enable expansion across additional ophthalmic indications.
OcuRing-K continues to be led by Dr. Ken Mandell, LayerBio’s founder and Chief Executive Officer, a Harvard-trained ophthalmologist and biotechnology innovator with more than a dozen INDs and multiple Phase 1–3 ophthalmic trials to his credit.
PainReform will provide further updates as the OcuRing-K program advances.
About PainReform
PainReform Ltd. (Nasdaq: PRFX) is a company focused on the reformulation of established therapeutics, and a developer of AI-driven energy optimization technologies through its DeepSolar platform. The Company’s pharmaceutical programs leverage a proprietary extended-release drug-delivery system intended to provide prolonged post-surgical pain relief while minimizing the need for repeated dosing and reducing reliance on opioids. Through DeepSolar, PainReform also delivers advanced software solutions that enable both consumers and enterprises to monitor, forecast, and optimize energy consumption—particularly in solar-integrated environments. This dual business model reflects PainReform’s strategic commitment to applying precision technology across high-impact sectors including healthcare and sustainable energy. For more information, please visit www.painreform.com.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements about PainReform’s expectations, beliefs and intentions including with respect to the development plan for OcuRing-K and its plans for the commencement of clinical trials. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: our ability to continue as a going concern, our history of significant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110 OcuRing™-K, LayerBio Inc.’s lead product candidate, and the commercialization of the DeepSolar solution; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110, OcuRing™-K and future product candidates; our limited experience managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; our ability to maintain our listing on the Nasdaq Capital Market; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting us is contained under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
FAQ
What did PainReform announce about OcuRing‑K on December 2, 2025 for PRFX?
What clinical evidence supports OcuRing‑K for PRFX investors?
How large is the cataract surgery market referenced in the PRFX announcement?
What is the planned regulatory path for OcuRing‑K under PRFX?
Will OcuRing‑K replace postoperative eye‑drop regimens according to PRFX?
Who leads the OcuRing‑K program mentioned by PRFX?
