Summary: development status as of September 2026

The BIM-IOL System is investigational and not approved in any jurisdiction. Two identical registrational phase 3 trials (SGP-005, Rhine, NCT07218783; SGP-006, Rhone, NCT07218796) compare the 78 mcg system with a commercial monofocal IOL plus twice-daily timolol 0.5%; each plans to enroll approximately 400 participants at 45 sites. The sponsor expects enrollment to complete in 2027, 12-month data in 2028, 24-month data in 2029, and submission of a 505(b)(2) NDA in 2028. The sponsor expects regulation as a drug-led, drug-device combination product with CDER as lead center and states no current plans to seek device premarket approval. No FDA expedited-program designation was identified in the sponsor's SEC filings. SpyGlass Pharma completed its initial public offering on Nasdaq (ticker SGP) in February 2026 with gross proceeds of $172.5 million.

Investigational status and registrational phase 3 program

“In July 2025, we initiated two registrational Phase 3 trials, each expected to enroll approximately 400 patients across 45 sites. We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) New Drug Application (NDA) to the FDA in 2028.” (opens the source at this quote in a new tab)
“We plan to complete Phase 3 enrollment by 2027 and report 12 month data in 2028 and 24 month data in 2029.” (opens the source at this quote in a new tab)

“Enrollment remains on track in the registrational Phase 3 trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), with completion of enrollment expected in 2027.” (opens the source at this quote in a new tab)

Phase 3 registry records

Field	SGP-005
Brief title	“Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)”
Start date	“2025-10-15”
Estimated primary completion date	“2029-03-31”
Estimated enrollment	“400”

Field	SGP-006
Brief title	“Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)”
Estimated primary completion date	“2029-05-31”
Estimated enrollment	“400”

FDA regulatory pathway: 505(b)(2) NDA

“We believe this approach positions us to pursue a streamlined regulatory approval process under the FDA’s 505(b)(2) pathway because the active ingredient in our BIM-IOL System, bimatoprost, has been previously approved by the FDA.” (opens the source at this quote in a new tab)
“We believe our approach is consistent with regulatory guidance from the FDA and we have communicated our strategy to seek approval via the 505(b)(2) pathway to the FDA. The FDA will ultimately determine our regulatory pathway following the submission of our 505(b)(2) NDA.” (opens the source at this quote in a new tab)

“If the FDA does not allow us to pursue the Section 505(b)(2) regulatory pathway for a product candidate as anticipated, we may need to conduct additional clinical trials, provide additional data and information and meet additional standards for regulatory approval.” (opens the source at this quote in a new tab)

Drug-device combination product: lead center and device component

“We believe this product candidate will be regulated by the FDA as a drug-led, drug-device combination product.” (opens the source at this quote in a new tab)
“While we have no current plans to seek premarket approval for any device products, our lead combination product candidate is subject to regulation by CDER and by CDRH, although CDER has primarily jurisdiction over the drug-led combination product. The device component of our combination product candidate must comply with the applicable medical device quality controls.” (opens the source at this quote in a new tab)

Investigational new drug application

“Our investigational new drug application (IND) for the Phase 1/2 trial of the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery was cleared by the FDA, and we completed enrollment in November 2024.” (opens the source at this quote in a new tab)

Initial public offering and SEC reporting status

“SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma”), a late-stage biopharmaceutical company, today announced the closing of its initial public offering of 10,781,250 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 1,406,250 additional shares of its common stock, at a public offering price of $16.00 per share. The aggregate gross proceeds from the offering were $172.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by SpyGlass Pharma.” (opens the source at this quote in a new tab)

“Cash, cash equivalents and short-term investments of $234.2 million on June 30, 2026, are expected to fund planned operations through 2028.” (opens the source at this quote in a new tab)

Patents and licensed intellectual property

“As of December 31, 2025, our co-owned and exclusively licensed patent estate contains eight (8) patent families comprising fifteen (15) issued U.S. patents” (opens the source at this quote in a new tab)
“The fifteen (15) issued U.S. patents are projected to expire between 2039 and 2043, before accounting for potentially available patent term adjustments or patent term extension, as appropriate, and assuming timely payment of appropriate maintenance, renewal, annuity and other governmental fees.” (opens the source at this quote in a new tab)
“All patents and patent applications in our intellectual property portfolio are co-owned with a single co-Applicant, the Regents of the University of Colorado, a body corporate (CU). We exclusively license the co-Applicant’s rights in these patents and patent applications that are co-owned.” (opens the source at this quote in a new tab)

Patent limitation: active ingredient in the public domain

“The selected API of our BIM-IOL System, bimatoprost, is an approved and known pharmaceutical that has been in the public domain and used for the treatment of eye disorders for many years and we are therefore not able to seek and obtain patent protection for the form of crystalline bimatoprost we use in our BIM-IOL System.” (opens the source at this quote in a new tab)

Regulatory exclusivity potentially applicable to a non-NCE product

“The FDCA also provides for a period of three years of non-patent exclusivity for non-NCE drugs if the NDA or NDA supplement includes reports of one or more new clinical investigations, other than bioavailability or bioequivalence studies, that were conducted by or for the applicant and are essential to the approval of the application or supplement.” (opens the source at this quote in a new tab)

Related product in development: BIM-DRS for pseudophakic participants

“Bimatoprost-Drug Ring System (BIM-DRS) first-in-human trial is on track to start in the second half of 2026.” (opens the source at this quote in a new tab)

Field	Quoted record
Brief title	“Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension”
Estimated enrollment	“24”

FDA fast track, breakthrough therapy, or other expedited-program designations

No evidence found.

Regulatory submission: NDA planned for 2028

“pending successful Phase 3 results, we plan to submit a 505(b)(2) New Drug Application (NDA) to the FDA in 2028 to seek approval of the BIM-IOL System” (opens the source at this quote in a new tab)

Launch

No evidence found.